Laboratory Manual
Course: 310
Subject: Practical
Course: 310
Subject: Practical
Pharmaceutical Engineering & Technology
Prepared By
Md. Imran Nur Manik
M.Pharm
Departmnt of Pharmacy
Uniersity of Rajshahi
Md. Imran Nur Manik
M.Pharm
Departmnt of Pharmacy
Uniersity of Rajshahi
Rajshahi-6205, Bangladesh
Available at
Essential Pharma documents
www.pharmacydocs.blogspot.com
Essential Pharma documents
www.pharmacydocs.blogspot.com
Serial No | Date | Name of the experiment | Page No. |
01 | 01.10.11 | Preparation of Paracetamol Suspension | 02‒06 |
02 | 01.10.11 | Preparation of Paracetamol syrup | 07‒11 |
03 | 02.10.11 | Preparation of Iron syrup | 12‒16 |
04 | 02.10.11 | Preparation of Antacid Suspension | 17‒19 |
05 | 02.10.11 | Preparation of Metronidazole Suspension | 20‒22 |
06 | 01.10.11 | Preparation of oil in water emulsion | 23‒26 |
Experiment Number : 01
|
Date : 01.10.2011
|
Name of The Experiment : Preparation of Paracetamol Suspension (100ml)
| |
Introduction:
Suspensions are biphasic liquid dosage form. A heterogeneous system in which the continuous phase is a liquid or semisolid, and the dispersed phase consists of a dispersed solid (size: 0.5 -5 micrometer).
Types of suspension:
1. According to aggregation of particles:
a) Flocculated suspension:
The suspension in which the dispersed particles are settling down easily and return to its original phase on stirring without delay, is called flocculated suspension. The rate of settling down is dependent on aggregation of particles. It is easy to redisperse. The flocculates stick to the side of the bottle.
1. According to aggregation of particles:
a) Flocculated suspension:
The suspension in which the dispersed particles are settling down easily and return to its original phase on stirring without delay, is called flocculated suspension. The rate of settling down is dependent on aggregation of particles. It is easy to redisperse. The flocculates stick to the side of the bottle.
b) Deflocculated suspension:
The suspension in which the dispersed particles are settling down and formed hard mass and by agitation do not return to the original phase easily, is called deflocculated suspension. It is very hard to redisperse. The preparation doesn’t stick to the side of the bottle.
The suspension in which the dispersed particles are settling down and formed hard mass and by agitation do not return to the original phase easily, is called deflocculated suspension. It is very hard to redisperse. The preparation doesn’t stick to the side of the bottle.
2. According to the route of administration:
√ Oral suspension :
i) Aqueous suspension. e.g. antacid suspension.
ii) Non-aqueous suspension. e.g. Mandelate oral suspension. iii) Dry granules .e.g. amoxicillin suspension.
√ Oral suspension :
i) Aqueous suspension. e.g. antacid suspension.
ii) Non-aqueous suspension. e.g. Mandelate oral suspension. iii) Dry granules .e.g. amoxicillin suspension.
√ Injectable suspension. e.g. Penicillin injection.
√ Topical suspension. e.g. calamine lotion.
√ Ophthalmic suspension. e.g. chloramphenicol.
√ Aerosol suspension. e.g. dexamethasone phosphate suspension.
√ Topical suspension. e.g. calamine lotion.
√ Ophthalmic suspension. e.g. chloramphenicol.
√ Aerosol suspension. e.g. dexamethasone phosphate suspension.
Properties of well formulated suspension:
♦ Suspension must be consisting of small and uniformly sized particles.
♦ If the suspension is allowed to stand, the dispersed particle settle down gradually and ultimately
two distinct phases are found after a certain period of time.
♦ The particles which settle to the bottom of the container should not pack into hard cake. The
sediment particles must be re-dispersed easily on agitation.
♦ The suspension should not be too viscous to pour freely from the orifice of the bottle.
♦ The suspension must be homogenous until the period of time to take the required dose.
♦ Viscosity must be controlled to reduce the rate of settling down of the particle.
♦ The suspension should have pleasing odor, color and taste.
♦ The product should not support bacterial growth during storage.
♦ If the suspension is allowed to stand, the dispersed particle settle down gradually and ultimately
two distinct phases are found after a certain period of time.
♦ The particles which settle to the bottom of the container should not pack into hard cake. The
sediment particles must be re-dispersed easily on agitation.
♦ The suspension should not be too viscous to pour freely from the orifice of the bottle.
♦ The suspension must be homogenous until the period of time to take the required dose.
♦ Viscosity must be controlled to reduce the rate of settling down of the particle.
♦ The suspension should have pleasing odor, color and taste.
♦ The product should not support bacterial growth during storage.
Advantages of suspension :
√ No suitable solvent available to dissolve drug (i.e. ZnO)
√ Mask unpleasant taste of drugs(i.e. garlic-like taste for chloramphenicol)
√ To increase chemical stability (Ex. Penicillin G rapid hydrolysis in solution)
√To Control Therapeutic Response
√ No suitable solvent available to dissolve drug (i.e. ZnO)
√ Mask unpleasant taste of drugs(i.e. garlic-like taste for chloramphenicol)
√ To increase chemical stability (Ex. Penicillin G rapid hydrolysis in solution)
√To Control Therapeutic Response
Formula:
Name of ingredient
|
Theoretical amount
|
Weighted amount
|
Paracetamol
|
2.4 gm
| |
Na-CMC
|
1 gm
| |
Sorbitol
|
10 ml
| |
Sugar syrup
|
20 ml
| |
Na methyl paraben
|
90 mg / 0.09 gm
| |
Na propyl paraben
|
10 mg / 0.01 gm
| |
Citric acid
|
0.2 gm
| |
Red dye
|
q.s
| |
Raspberry flavor
|
q.s
| |
Distilled water
|
q.s
|
Apparatus:
1.Mortar 3.Filter paper 5.Stirrer 7.Measuring cylinder 9.Beaker.
2. Pastle 4.Bottle 6. Funnel 8. Droppers
2. Pastle 4.Bottle 6. Funnel 8. Droppers
Method of preparation:
1. The mortar was cleaned thoroughly. About 1gm of Na-CMC was weighed & transferred into the mortar. A few (about 20 ml) of water was added, triturated & allowed to stand for 15 minutes to proper swelling the Na-CMC.
2. When 2.4 gm dry Paracetamol powder was mixed & triturated properly and rapidly.
3. Then 20 ml of sugar syrup was added & 10 ml of sorbitol was added in a small quantity of a time with constant triturating so as to get a homogeneous product. It’s a primary suspension. All preservatives are dissolved & added.
4.The suspension was transferred to a measuring cylinder of flask & more of vehicle (e.g. Dist. Water) was added to produce the final volume 100 ml, stirred thoroughly so to form a uniform suspension. The suspension was transferred to a bottle, closed properly & labeled.
Function of each ingredient:
1.Paracetamol :
Properties:
i. white crystalline odorless bitter tasted powder
ii. It is the active ingredient of the preparation acting as antipyretic & analgesic.
i. white crystalline odorless bitter tasted powder
ii. It is the active ingredient of the preparation acting as antipyretic & analgesic.
2. Na-CMC :
Properties:
i. it is white to faintly yellow in color
ii. Odorless
iii. hygroscopic powder
iv. soluble in water & insoluble in organic solvents
v. It shows pseudo-plastic flow behavior.
Function:
i. As suspending agent
ii. viscosity imparting agent.
3. Sorbitol :
Properties:
i. White or almost colorless crystalline, odorless, hygroscopic powder also available as
granule flakes and pellets to prevent caking.
ii. Pleasant, cooling, sweet taste ( 50-60 % the sweetness of sucrose )
iii. Melting point 110-112ºC ( anhydrous )
iv. Solubility : very soluble in water and soluble in warm alcohol and glycerin and slightly soluble in hydrocarbons.
v. Stability and storage conditions : sorbitol is relatively chemically inert and compatible
with most excipients.
vi . It is stable in air in the absence of catalysts and in colds dolutes acids and bases
vii .It is nonflammable noncorrosive and nonvolatile
viii.In high concentration Sorbitol is stabilizer for Labile Vitamins and antibiotics
ix . Since it is hygroscopic it should be stored in a tightly sealed container.
Funtions :
i . Sweetenening agent ( 25-90 % ) substitute for glycerin and propylene glycol
ii . Humactant ( 3-15 % )concentration
iii . Binder and moisture control agent ( 3-10 % ) in tablets
iv . Viscosity agent (25-90 % )
Properties:
i. it is white to faintly yellow in color
ii. Odorless
iii. hygroscopic powder
iv. soluble in water & insoluble in organic solvents
v. It shows pseudo-plastic flow behavior.
Function:
i. As suspending agent
ii. viscosity imparting agent.
3. Sorbitol :
Properties:
i. White or almost colorless crystalline, odorless, hygroscopic powder also available as
granule flakes and pellets to prevent caking.
ii. Pleasant, cooling, sweet taste ( 50-60 % the sweetness of sucrose )
iii. Melting point 110-112ºC ( anhydrous )
iv. Solubility : very soluble in water and soluble in warm alcohol and glycerin and slightly soluble in hydrocarbons.
v. Stability and storage conditions : sorbitol is relatively chemically inert and compatible
with most excipients.
vi . It is stable in air in the absence of catalysts and in colds dolutes acids and bases
vii .It is nonflammable noncorrosive and nonvolatile
viii.In high concentration Sorbitol is stabilizer for Labile Vitamins and antibiotics
ix . Since it is hygroscopic it should be stored in a tightly sealed container.
Funtions :
i . Sweetenening agent ( 25-90 % ) substitute for glycerin and propylene glycol
ii . Humactant ( 3-15 % )concentration
iii . Binder and moisture control agent ( 3-10 % ) in tablets
iv . Viscosity agent (25-90 % )
4. Methyl & Propyl paraben:
Properties:
i. It is colorless crystal or white crystalline powder
ii. Odorless
iii. Slightl burning in taste
iv. Soluble in organic solvents & insoluble in water
v. Melting point: 125-1280C.
vi. In rare instsances it can elicit skin sensitization and induce cutaneous allergy responses.
Properties:
i. It is colorless crystal or white crystalline powder
ii. Odorless
iii. Slightl burning in taste
iv. Soluble in organic solvents & insoluble in water
v. Melting point: 125-1280C.
vi. In rare instsances it can elicit skin sensitization and induce cutaneous allergy responses.
Function:
i. As sweetening agent & preservative.
ii. Combination of paraben are used to obtained synergistic effect.
5. Sucrose syrup & Na-saccharine: These are used in the preparation as sweetening agent to mask
the bitter taste of preparation.
Sucrose syrup:
Properties:
i. Colorless or Brown , Odorless, Crystalline Powder.
ii. It has a sweet taste.
iii. Free flowing (crystalline sucrose)
iv. Cohesive solid (Powder Sucrose)
v. Melting Point 168-186 º C
vi. Good stability at room temperature and at moderate relative humidity.
vii. Diluents solutions are liable to attack by microorganisms.
viii.Sucrose is considered to be more carcinogenic than other carbohydrates because it is
more easily converted to dental plaque.
ix. Viscous in nature.
x. Concentration is 67% w/v
i. As sweetening agent & preservative.
ii. Combination of paraben are used to obtained synergistic effect.
5. Sucrose syrup & Na-saccharine: These are used in the preparation as sweetening agent to mask
the bitter taste of preparation.
Sucrose syrup:
Properties:
i. Colorless or Brown , Odorless, Crystalline Powder.
ii. It has a sweet taste.
iii. Free flowing (crystalline sucrose)
iv. Cohesive solid (Powder Sucrose)
v. Melting Point 168-186 º C
vi. Good stability at room temperature and at moderate relative humidity.
vii. Diluents solutions are liable to attack by microorganisms.
viii.Sucrose is considered to be more carcinogenic than other carbohydrates because it is
more easily converted to dental plaque.
ix. Viscous in nature.
x. Concentration is 67% w/v
Functions:
i. As Sweetening Agent ii. Viscosity increasing agent.
i. As Sweetening Agent ii. Viscosity increasing agent.
6. Citric acid:
Properties:
i. Translucent crystal or white crystal or granular to fine crystalline powder
ii. Colorless and odorless,
iii. Strong acidic taste & Effervescent in dry air
iv. Very soluble in water freely soluble in alcohol and sparingly soluble in ether,
v. Melting point 100°C (Monohydrate) , 153°C (anhydrous)
Properties:
i. Translucent crystal or white crystal or granular to fine crystalline powder
ii. Colorless and odorless,
iii. Strong acidic taste & Effervescent in dry air
iv. Very soluble in water freely soluble in alcohol and sparingly soluble in ether,
v. Melting point 100°C (Monohydrate) , 153°C (anhydrous)
Functions:
i. Buffering agent iii. Antioxidant synergist v. acidifying agent
ii. Sequestering agent iv. Flavor enhancer vi. Plasticizer.
i. Buffering agent iii. Antioxidant synergist v. acidifying agent
ii. Sequestering agent iv. Flavor enhancer vi. Plasticizer.
7. Raspberry oil : used as flavoring agent & prevent oxidative degradation.
8. Red dye : Used as a coloring agent for good suspension.
9. Distilled water : Used as a vehicle.
Other ingredients that can be used :
♦Active ingredients: Aspirin or Indomethacin.
♦Suspending agent: methyl cellulose, ethyl cellulose, hydroxyl propyl cellulose.
♦Preservatives: Na benzoate, Benzoic acid.
♦Coloring agent: Amarantin
♦Flavoring agent: peppermint oil.
♦Antioxidant: ascorbic acid.
Indications:
It is used as antipyretic & analgesic agent without significant anti-inflammatory action. It is indicated in mild to moderate pain ( musle pain, headache, tension, lumbago, neckache, pyrexia etc.)
♦Active ingredients: Aspirin or Indomethacin.
♦Suspending agent: methyl cellulose, ethyl cellulose, hydroxyl propyl cellulose.
♦Preservatives: Na benzoate, Benzoic acid.
♦Coloring agent: Amarantin
♦Flavoring agent: peppermint oil.
♦Antioxidant: ascorbic acid.
Indications:
It is used as antipyretic & analgesic agent without significant anti-inflammatory action. It is indicated in mild to moderate pain ( musle pain, headache, tension, lumbago, neckache, pyrexia etc.)
Contraindications : Hepatic & renal impairment.
Paracetamol BP 100ml Suspension Composition: Antipyretic , Analgesic Each 5 ml contain BP120mg Palatable suspension 100ml sugar free Indication: Batch no 0171740 Fever ,Common cold, Influenga ,Headache Mfg. Date : October.2011 Dose: As Directed By The Physician. Exp Date : October.2012 Storage condition : Keep in cool and dry place. Precaution : Shake before use. Keep every medicine out of reach of children.
Manufactured by: Laboratory of Pharmacy ;RajshahiUniversity.Rajshahi-6205
|
Market preparation:
Trade Name Manufacturer Name
Ace Square
Napa Beximco
Apa Opsonin
Pyralzin Renata
Xcel ACI
Measurement of viscosity:
Ace Square
Napa Beximco
Apa Opsonin
Pyralzin Renata
Xcel ACI
Measurement of viscosity:
The viscosity of the formulation was determined by Brookfield Viscometer (Model LV using spindle 3 at 30 rpm). The viscosity of the formulation = multiplication of dial reading and viscosity factor.
= 6 40
= 240
= 6 40
= 240
Experiment Number : 02
|
Date : 01.10.2011
|
Name of The Experiment : Preparation of Paracetamol Syrup (100ml)
| |
Syrups
Concentrated viscous liquid preparation containing large amount of dissolved sugar (or sugar substituent) with or without flavoring agents and medicinal substances. The concentration of sugar in syrup should be 66.7%.
Concentrated viscous liquid preparation containing large amount of dissolved sugar (or sugar substituent) with or without flavoring agents and medicinal substances. The concentration of sugar in syrup should be 66.7%.
Syrup types:
Non-medicated syrup: contain flavoring agents but not medicinal substances. For example, Cherry syrup. Cocoa syrup, orange syrup, raspberry syrup etc.
Non-medicated syrup: contain flavoring agents but not medicinal substances. For example, Cherry syrup. Cocoa syrup, orange syrup, raspberry syrup etc.
Medicated syrup: contain therapeutic agents. Medicated syrup is formulated by the components; sucrose, purified water, flavoring agent & other excipients.
Components of Syrup:
√ Sucrose or sucrose substitutes: provide sweetening effects and viscosity.
√ Antimicrobial preservatives
√ Flavorings
√ Colorants
√ Medicated syrups contain special solvents, solubilizing agents, thickeners or stabilizers
along with active ingredients.
√ Sucrose or sucrose substitutes: provide sweetening effects and viscosity.
√ Antimicrobial preservatives
√ Flavorings
√ Colorants
√ Medicated syrups contain special solvents, solubilizing agents, thickeners or stabilizers
along with active ingredients.
Advantages of Syrup:
i. Syrups retard oxidation because it is partly hydrolysed into reducing sugar such as levulose and
dextrose.
ii. It prevents decomposition of many vegetable substances, syrupshave high osmotic pressure which
prevents microbial growth.
iii.They are palatable due to presence of sugar, suitable vehicle for administration of bitter and bad
odorous substances.
iv.They are more quickly effective than solid dosages (e.g. tablet, capsule etc.)
v. They are homogenous formulation so the active ingredients are also homogenously distributed.
vi.This is a suitable formulation for pediatric and geriatric patients.
i. Syrups retard oxidation because it is partly hydrolysed into reducing sugar such as levulose and
dextrose.
ii. It prevents decomposition of many vegetable substances, syrupshave high osmotic pressure which
prevents microbial growth.
iii.They are palatable due to presence of sugar, suitable vehicle for administration of bitter and bad
odorous substances.
iv.They are more quickly effective than solid dosages (e.g. tablet, capsule etc.)
v. They are homogenous formulation so the active ingredients are also homogenously distributed.
vi.This is a suitable formulation for pediatric and geriatric patients.
Disadvantages of Syrup:
i, It is possible in a closed container of syrup for surface dilution due to solvent evaporation.
ii Solvent evaporation condenses upper internal surface of the container and then flows back on to the
surface of the product which provide an ideal medium for the growth of certain microorganism.
iii.During storage and use of syrup involves crystallization of the sugar within the screw cap. This
problem is solved by addition of polyhydric alcohols.
i, It is possible in a closed container of syrup for surface dilution due to solvent evaporation.
ii Solvent evaporation condenses upper internal surface of the container and then flows back on to the
surface of the product which provide an ideal medium for the growth of certain microorganism.
iii.During storage and use of syrup involves crystallization of the sugar within the screw cap. This
problem is solved by addition of polyhydric alcohols.
Dose:
Paracetamol or acetaminophen is an analgesic & antipyretic drug. Syrup form is more preferable for the children. Usual dose (tablet) is 500mg for adults 4-6 hourly & 250mg for children 4-6 hourly. The dose of syrup is : Children (6-12yrs) : 4-6 tea spoonful syrup 3-4 times
Children (below 1yr) : ½ tea spoonful syrup 3-4 times.
Paracetamol or acetaminophen is an analgesic & antipyretic drug. Syrup form is more preferable for the children. Usual dose (tablet) is 500mg for adults 4-6 hourly & 250mg for children 4-6 hourly. The dose of syrup is : Children (6-12yrs) : 4-6 tea spoonful syrup 3-4 times
Children (below 1yr) : ½ tea spoonful syrup 3-4 times.
Formula:
Name of ingredient
|
Theoretical amount
|
Weighed amount
|
Paracetamol BP
|
2.52 gm
| |
Propylene glycol
|
25 ml
| |
Sucrose syrup (65%)
|
20 ml
| |
Sorbitol
|
10 ml
| |
Glycerin
|
12 ml
| |
Na methyl paraben
|
180 mg
| |
Na propyl paraben
|
20 mg
| |
Na saccharin
|
10 mg
| |
Citric acid
|
q.s
| |
Raspberry flavor
|
q.s
| |
Raspberry Red dye
|
q.s
| |
Distilled water
|
q.s upto 100 ml
|
Apparatus:
1. Beaker. 3.Filter paper 5.Stirrer
2. Measuring cylinder 4.Bottle 6. Funnel
Calculation:
100ml syrup contain 2.4 gm or 2400 mg of paracetamol
So , 1ml ” ” = 2400100 mg of ’’
100ml syrup contain 2.4 gm or 2400 mg of paracetamol
So , 1ml ” ” = 2400100 mg of ’’
So, 5ml ” ” = 24005100 mg of ’’
= 120 mg of paracetamol
Average 5 % , So
100mg contain excess 5 mg of paracetamol
So , 1 mg ” ” = 5100 ”
2400 mg ” ” = 24005100 ”
120 mg of paracetamol
So, total weights = ( 2400+120 ) mg
= 2520 mg
= 2.52 gm
Recipe : For 100 ml paracetamol syrup
Each 5 ml contains 120 mg of paracetamol BP
Since 5 ml contains 120 mg , 100 ml contain 2400 mg or 2.4 gm
= 2.52 gm
Recipe : For 100 ml paracetamol syrup
Each 5 ml contains 120 mg of paracetamol BP
Since 5 ml contains 120 mg , 100 ml contain 2400 mg or 2.4 gm
Method of preparation:
1. 2.52 gm Paracetamol powder was dissolved in 25 ml of propylene glycol in a beaker.
2. 65% sucrose syrup was prepared. Then 20 ml syrup & 10 ml sorbitol was taken & mixed in a
beaker.12 ml glycerin, 10 mg Na saccharin, 180mg methyl paraben & 20 mg propyl paraben ware
mixed together in another beaker. Then 2 solutions were mixed together.
3. After mixing all portions, flavor (orange) & color were added. At this point pH was checked to
calculate the amount of citric acid needed as buffer
4. The sufficient quantity of citric acid was adeed to the preparation
5. Finally syrup was transferred to a measuring flask & volume was raised to 100 ml by adding water.
6. The preparation was transferred to a bottle, closed properly & labeled.
1. 2.52 gm Paracetamol powder was dissolved in 25 ml of propylene glycol in a beaker.
2. 65% sucrose syrup was prepared. Then 20 ml syrup & 10 ml sorbitol was taken & mixed in a
beaker.12 ml glycerin, 10 mg Na saccharin, 180mg methyl paraben & 20 mg propyl paraben ware
mixed together in another beaker. Then 2 solutions were mixed together.
3. After mixing all portions, flavor (orange) & color were added. At this point pH was checked to
calculate the amount of citric acid needed as buffer
4. The sufficient quantity of citric acid was adeed to the preparation
5. Finally syrup was transferred to a measuring flask & volume was raised to 100 ml by adding water.
6. The preparation was transferred to a bottle, closed properly & labeled.
Function of each ingredient:
1. Paracetamol: white crystalline odorless bitter tasted powder. It is sparingly soluble in water (1:10). propylene glycol may be used for good solubility but it is bitter. That’s why sweetening agents are used. It is the active ingredient of the preparation acting as antipyretic & analgesic.
2. Glycerin:
Properties:
i. Clear, colorless, odorless iii. Viscous
ii. Hygroscopic in nature iv. Sweet in taste
Properties:
i. Clear, colorless, odorless iii. Viscous
ii. Hygroscopic in nature iv. Sweet in taste
Functions:
♦Solvent, ♦Sweetening agent
♦Antimicrobial agent ♦Viscosity imparting agent
♦Solvent, ♦Sweetening agent
♦Antimicrobial agent ♦Viscosity imparting agent
3. Sucrose syrup & Na saccharin:
Sucrose syrup and Sodium-Saccharin: These are used in the preparation as sweetening agent to
mask the bitter taste of preparation.
Sucrose syrup and Sodium-Saccharin: These are used in the preparation as sweetening agent to
mask the bitter taste of preparation.
Sucrose syrup:
Properties:
♦ Colorless or Brown , Odorless, Crystalline Powder.
♦ It has a sweet taste.
♦ Free flowing (crystalline sucrose)
♦ Cohesive solid (Powder Sucrose)
♦ Melting Point 168-186 º C
♦ Good stability at room temperature and at moderate relative humidity.
♦ Diluents solutions are liable to attack by microorganisms.
♦ Sucrose is considered to be more carcinogenic than other carbohydrates because it is more easily converted to dental plaque.
♦ Viscous in nature.
♦ Concentration is 67% w/v
Properties:
♦ Colorless or Brown , Odorless, Crystalline Powder.
♦ It has a sweet taste.
♦ Free flowing (crystalline sucrose)
♦ Cohesive solid (Powder Sucrose)
♦ Melting Point 168-186 º C
♦ Good stability at room temperature and at moderate relative humidity.
♦ Diluents solutions are liable to attack by microorganisms.
♦ Sucrose is considered to be more carcinogenic than other carbohydrates because it is more easily converted to dental plaque.
♦ Viscous in nature.
♦ Concentration is 67% w/v
Functions:
♦Sweetening Agent ♦Viscosity imparting agent.
♦Sweetening Agent ♦Viscosity imparting agent.
4. Methyl & Propyl paraben:
Properties:
i. It is colorless crystal or white crystalline powder
ii. Odorless
iii. Slightl burning in taste
iv. Soluble in organic solvents & insoluble in water
v. Melting point: 125-1280C.
vi. In rare instsances it can elicit skin sensitization and induce cutaneous allergy responses.
Properties:
i. It is colorless crystal or white crystalline powder
ii. Odorless
iii. Slightl burning in taste
iv. Soluble in organic solvents & insoluble in water
v. Melting point: 125-1280C.
vi. In rare instsances it can elicit skin sensitization and induce cutaneous allergy responses.
Function:
i. As sweetening agent & preservative.
ii. Combination of paraben are used to obtained synergistic effect.
i. As sweetening agent & preservative.
ii. Combination of paraben are used to obtained synergistic effect.
5. Citric acid:
Properties:
i . Translucent crystal or white crystal or granular to fine crystalline powder.
ii . Colorless and odorless
iii .Strong acidic taste
iv .Effervescent in dry air
v .Very soluble in water freely soluble in alcohol and sparingly soluble in ether
vi .Melting point 100°C ( Monohydrate ) , 153°C ( anhydrous )
Functions:
♦ Buffering agent ♦ Sequestering agent
♦ acidifying agent ♦ Plasticize
♦ Flavor enhancer ♦ Antioxidant synergist.
6. Orange : It is used as a coloring & sweeting agent.
Other ingredients that can be used:
√ Vehicle: microgols
√ Sweetening agent: sorbitol
√ Preservatives: Na benzoate, Benzoic acid.=
√ Coloring agent: Amaranten, Apple green.
√ Flavoring agent: peppermint oil, clove oil, vanilla, lemon oil etc.
√ Buffer: Na-citrate, K-bi sulfite.
Properties:
i . Translucent crystal or white crystal or granular to fine crystalline powder.
ii . Colorless and odorless
iii .Strong acidic taste
iv .Effervescent in dry air
v .Very soluble in water freely soluble in alcohol and sparingly soluble in ether
vi .Melting point 100°C ( Monohydrate ) , 153°C ( anhydrous )
Functions:
♦ Buffering agent ♦ Sequestering agent
♦ acidifying agent ♦ Plasticize
♦ Flavor enhancer ♦ Antioxidant synergist.
6. Orange : It is used as a coloring & sweeting agent.
Other ingredients that can be used:
√ Vehicle: microgols
√ Sweetening agent: sorbitol
√ Preservatives: Na benzoate, Benzoic acid.=
√ Coloring agent: Amaranten, Apple green.
√ Flavoring agent: peppermint oil, clove oil, vanilla, lemon oil etc.
√ Buffer: Na-citrate, K-bi sulfite.
Indications:
It is used as antipyretic & analgesic agent without significant anti inflammatory action. It is indicated in mild to moderate pain (myalgia, headache, neckache), pyrexia etc.
Contraindications : Hepatic & renal impairment.
Paracetamol BP 100ml Suspension Composition: Each 5 ml contain BP120mg Antipyretic , Analgesic Indication: Palatable suspension 100ml sugar free Fever ,Common cold, Influenga ,Headache Batch no 0171740 Dose: As Directed By The Physician Mfg. Date: October.2011 Storage condition : Keep in cool and dry place Exp Date : October.2012 Precaution : Shake before use Keep every medicine out of reach of children.
Manufactured by: Laboratory of Pharmacy ;RajshahiUniversity.Rajshahi-6205
|
Market preparation :
Trade Name Manufacturer Name
Ace Square
Napa Beximco
Fast Acme
Reset Incepta
Xcel ACI
Measurement of viscosity:
Ace Square
Napa Beximco
Fast Acme
Reset Incepta
Xcel ACI
Measurement of viscosity:
The viscosity of the formulation was determined by Brookfield Viscometer (Model LV using spindle 3 at 30 rpm). The viscosity of the formulation = multiplication of dial reading and viscosity factor. = 6 40
= 240
= 240
Experiment Number : 03
|
Date : 02.10.2011
|
Name of The Experiment : Preparation of Iron Syrup (100ml)
| |
Introduction
Syrups are concentrated, aqueous preparation of sugar or sugar substitute with or without added flavoring agents and medicinal substances. Hematinic preparations are the agents, which are used in the treatment of anaemia.Theyincreases the amount of R.B.C. or hemoglobin content or both to normal level.
Syrups are concentrated, aqueous preparation of sugar or sugar substitute with or without added flavoring agents and medicinal substances. Hematinic preparations are the agents, which are used in the treatment of anaemia.Theyincreases the amount of R.B.C. or hemoglobin content or both to normal level.
A decrease in O2 carrying capacity of blood is termed as anaemia. The oxygen carrying capacity is determined by hemoglobin content of the erythrocytes. Hence in a reduction in the blood hemoglobin level & in the number of circulating erythrocytes is the characterization of anaemia.
Classification
According to the etiology,anaemia may be classified as follows:
♦ Anaemia due to blood loss by haemorrhage.
♦ Anaemia due to dietary deficiency of factors essential for normal blood production .
e.g.Iron Folic Acid.
♦ Anaemia due to excessive blood cell destruction in comparision to the production .
♦ Anaemia due to aplasia, hypoplasia, or destruction of bone marrow.
♦ Anaemia due to infection, rheumatic arthritis etc.
♦ Anaemia due to defective formation of R.B.C.
According to the etiology,anaemia may be classified as follows:
♦ Anaemia due to blood loss by haemorrhage.
♦ Anaemia due to dietary deficiency of factors essential for normal blood production .
e.g.Iron Folic Acid.
♦ Anaemia due to excessive blood cell destruction in comparision to the production .
♦ Anaemia due to aplasia, hypoplasia, or destruction of bone marrow.
♦ Anaemia due to infection, rheumatic arthritis etc.
♦ Anaemia due to defective formation of R.B.C.
Iron deficiency anaemia caused by deficient synthesis of haemoglobin in which iron is an important constant. Iron is present in every cell of the body usually varies between 2.5 gm depending on their body weight and haemoglobin level. There is a different between male and female .Thus the estimation of Iron content for male is about 50mg per kg of body weight whereas for adult female it is about 35 mg/kg per body weight.
Iron preparations are used in the management of the following disorders -
1. Iron deficiency anaemia.
2. Pregnancy and lactation induced iron deficiency.
3. Mal absorption syndrome.
4. Menstruating women.
5. Premature babies.
6. Professional blood donors.
1. Iron deficiency anaemia.
2. Pregnancy and lactation induced iron deficiency.
3. Mal absorption syndrome.
4. Menstruating women.
5. Premature babies.
6. Professional blood donors.
Apparatus:
1. Beaker 3.Filter paper 5.Stirrer 7.Measuring cylinder 9. Electric balance
2. Pipette 4.Bottle 6. Funnel 8. Glass - rod
1. Beaker 3.Filter paper 5.Stirrer 7.Measuring cylinder 9. Electric balance
2. Pipette 4.Bottle 6. Funnel 8. Glass - rod
Recipe:
For 1000 ml Iron Syrup:
Each 5 ml contains 200 mg of FeSO4
Each 5 ml contains 200 mg of FeSO4
Since 5 ml contains 200 mg of FeSO4
Then 100 ml contains = 2001005 mg of FeSO4
=4000 mg of FeSO4
=4 gm of FeSO4
=4000 mg of FeSO4
=4 gm of FeSO4
Formula for 100 ml Iron syrup:
Name of the ingredient
|
Theoretical weight
|
Weighed amount
|
FeSO4
|
4.4 gm
| |
Citric acid
|
0.3 gm
| |
Ascorbic acid
|
0.2 gm
| |
Liquid Glucose
|
10 ml
| |
Sucrose Syrup
|
20 ml
| |
Methyl Paraben
|
180 mg
| |
Propyl Paraben
|
20 mg
| |
Sodium saccharin
|
10 mg
| |
Glycerin
|
5 ml
| |
Raspberry Flavor
|
q.s
| |
Raspberry Red Color
|
q.s
| |
Distilled Water
|
q.s to 100 ml
|
Method of Preparation:
1.4.4 gm of FeSO4 was taken in a clean beaker & some amount of distilled water was added with stirring to dissolve the FeSO4.
2. About 0.3 gm of citric acid & 0.2 gm of ascorbic acid was added quickly to the beaker with stirring to dissolve them very well.
3. In another beaker ;methyl paraben ,propyl paraben, and sodium saccharin was dissolved in 20 ml sucrose syrup. Then in this sucrose solution 10 ml liquid glucose and 5 ml glycerin was added & stirred thoroughly to mix them very well.
4. This solution was added to FeSO4 solution and stirred thoroughly to obtain homogenous mixing.
5. Raspberry Flavor and color was added & stirred.
6. The whole preparation was filtered & transferred to a measuring cylinder and the solution volume was made 100 ml with sufficient quantity of water. Then it was transferred to a bottle .The bottle was corked and labeled well.
Function of the ingredients:
1. FeSO4: It is the active ingredient of the preparation and acts as Hematinic agent.
Properties:
√ Physical form : Crystal or crystalline powder
√ Color : Green or Greenish in color
√ Odor : Odorless
√ Taste : Metallic in taste
√ Nature : Acidic in nature
√ PH : Is about 3.7
Properties:
√ Physical form : Crystal or crystalline powder
√ Color : Green or Greenish in color
√ Odor : Odorless
√ Taste : Metallic in taste
√ Nature : Acidic in nature
√ PH : Is about 3.7
Applications:
i. In Iron deficiency syndrome.
ii. In Hematinic preparations.
2. Citric acid:
Properties:
i . Translucent crystal or white crystal or granular to fine crystalline powder.
ii . Colorless and odorless
iii .Strong acidic taste
iv .Effervescent in dry air
v .Very soluble in water freely soluble in alcohol and sparingly soluble in ether
vi .Melting point 100°C ( Monohydrate ) , 153°C ( anhydrous )
Functions:
♦ Buffering agent ♦ Sequestering agent
♦ acidifying agent ♦ Plasticize
♦ Flavor enhancer ♦ Antioxidant synergist.
3. Ascorbic acid:
Properties:
√ Physical form : Crystalline powder
√ Color : White or Light Yellow
√ Odor : Odorless
√ Taste : Acidic in taste √ Nature : Acidic in nature
√ PH : Is between 2.1-2.6
i. In Iron deficiency syndrome.
ii. In Hematinic preparations.
2. Citric acid:
Properties:
i . Translucent crystal or white crystal or granular to fine crystalline powder.
ii . Colorless and odorless
iii .Strong acidic taste
iv .Effervescent in dry air
v .Very soluble in water freely soluble in alcohol and sparingly soluble in ether
vi .Melting point 100°C ( Monohydrate ) , 153°C ( anhydrous )
Functions:
♦ Buffering agent ♦ Sequestering agent
♦ acidifying agent ♦ Plasticize
♦ Flavor enhancer ♦ Antioxidant synergist.
3. Ascorbic acid:
Properties:
√ Physical form : Crystalline powder
√ Color : White or Light Yellow
√ Odor : Odorless
√ Taste : Acidic in taste √ Nature : Acidic in nature
√ PH : Is between 2.1-2.6
Functions:
√ Antioxidant (0.01-0.1% w/v)
√ Stabilizing agent
√ PH adjusting agent
√ Antioxidant (0.01-0.1% w/v)
√ Stabilizing agent
√ PH adjusting agent
4. Liquid glucose
Properties:
i . Colorless & odorless
ii . Viscous sweet testing liquid
iii . Soluble in H2O, partly in ethanol
iv . Viscosity 13-14.5
Properties:
i . Colorless & odorless
ii . Viscous sweet testing liquid
iii . Soluble in H2O, partly in ethanol
iv . Viscosity 13-14.5
Functions:
i . Sweeting agent
ii . Used as vehicle
5. Sucrose syrup: These are used in the preparation as sweetening agent to mask the bitter taste of preparation.
Properties:
i. Colorless or Brown , Odorless, Crystalline Powder.
ii. It has a sweet taste.
iii. Free flowing (crystalline sucrose)
iv. Cohesive solid (Powder Sucrose)
v. Melting Point 168-186 º C
vi. Good stability at room temperature and at moderate relative humidity.
vii. Diluents solutions are liable to attack by microorganisms.
viii.Sucrose is considered to be more carcinogenic than other carbohydrates because it is
more easily converted to dental plaque.
ix. Viscous in nature.
x. Concentration is 67% w/v
i . Sweeting agent
ii . Used as vehicle
5. Sucrose syrup: These are used in the preparation as sweetening agent to mask the bitter taste of preparation.
Properties:
i. Colorless or Brown , Odorless, Crystalline Powder.
ii. It has a sweet taste.
iii. Free flowing (crystalline sucrose)
iv. Cohesive solid (Powder Sucrose)
v. Melting Point 168-186 º C
vi. Good stability at room temperature and at moderate relative humidity.
vii. Diluents solutions are liable to attack by microorganisms.
viii.Sucrose is considered to be more carcinogenic than other carbohydrates because it is
more easily converted to dental plaque.
ix. Viscous in nature.
x. Concentration is 67% w/v
Functions:
i. As Sweetening Agent ii. Viscosity increasing agent.
6. Methyl & Propyl paraben:
Properties:
i. It is colorless crystal or white crystalline powder
ii. Odorless
iii. Slightl burning in taste
iv. Soluble in organic solvents & insoluble in water
v. Melting point: 125-1280C.
vi. In rare instsances it can elicit skin sensitization and induce cutaneous allergy responses.
i. As Sweetening Agent ii. Viscosity increasing agent.
6. Methyl & Propyl paraben:
Properties:
i. It is colorless crystal or white crystalline powder
ii. Odorless
iii. Slightl burning in taste
iv. Soluble in organic solvents & insoluble in water
v. Melting point: 125-1280C.
vi. In rare instsances it can elicit skin sensitization and induce cutaneous allergy responses.
Function:
i. As sweetening agent & preservative.
ii. Combination of paraben are used to obtained synergistic effect.
i. As sweetening agent & preservative.
ii. Combination of paraben are used to obtained synergistic effect.
7. Glycerin:
Properties:
i. Clear, colorless, odorless iii. Viscous
ii. Hygroscopic in nature iv. Sweet in taste
Functions:
♦ Solvent, ♦ Sweetening agent
♦ Antimicrobial agent ♦ Viscosity imparting agent
Properties:
i. Clear, colorless, odorless iii. Viscous
ii. Hygroscopic in nature iv. Sweet in taste
Functions:
♦ Solvent, ♦ Sweetening agent
♦ Antimicrobial agent ♦ Viscosity imparting agent
8. Raspberry Flavor : Acts as flavorings agent
9.Raspberry Red Color : Acts as coloring agent
10. Distilled Water : Acts as vehicle
9.Raspberry Red Color : Acts as coloring agent
10. Distilled Water : Acts as vehicle
Market preparation:
Trade Name Manufacturer Name
Caron Square
Aristoferon Beximco
Opsoferot Opsonin
Ferroglobin Acme
Bioron Biopharma
Trade Name Manufacturer Name
Caron Square
Aristoferon Beximco
Opsoferot Opsonin
Ferroglobin Acme
Bioron Biopharma
R-Iron Syrup 100 ml Each 5 ml contains Ferrous sulphate BP 200 ml
Batch no. Indications : Irondeficiency syndrome andAnaemia.
Mfg. Date: October.2011 Dose: Exp Date : October.2012 For adult :1-2 teaspoon full two times daily. For children : 12 -1 teaspoon full two times daily, before, or after meal or as directed by Physician. Precaution : Shake before use. Keep every medicine out of reach of children. Storage : Store in cool and dry place.
Manufactured by: Laboratory of Pharmacy ;RajshahiUniversity.Rajshahi-6205
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Experiment Number : 04
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Date : 02.10.2011
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Name of The Experiment : Preparation of Antacid Suspension (100ml)
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Introduction
Gastric antacids are drugs whichnare used to redcuce the acidity of GIT .They react with gastric HCL and neutralize the acids as followings
Al (OH) 3+3HCL
AlCl3+3 H2O
Gastric antacids are drugs whichnare used to redcuce the acidity of GIT .They react with gastric HCL and neutralize the acids as followings
Al (OH) 3+3HCL
AlCl3+3 H2O
These are prescribed for symptomatic relief of hyperacidity associated with diagnosis of peptic ulcer, gastritis, peptic oesophagitis and gastric hyperacidity.
It also increases the tone of oesophagitis spincture and reduces the reflex of acids ,gastric contents into the oesophagitis. These drugs act as weak base. They raise the gastric PH above 4, but certain antacid like NaHCO3 raised the gastric PH to 7.
Classification:
Antacids are classified into two groups.
Antacids are classified into two groups.
a. Systemic Antacid:
A Systemic antacid is one which is capable of producing metabolic alkalosis because the certain moiety does not form insoluble basic compound in the intestine e.g. NaHCO3, KHCO3 Na-citrate etc. are mainly used to counter compact systemic alkalosis.
A Systemic antacid is one which is capable of producing metabolic alkalosis because the certain moiety does not form insoluble basic compound in the intestine e.g. NaHCO3, KHCO3 Na-citrate etc. are mainly used to counter compact systemic alkalosis.
b. Non Systemic Antacid:
A non- insoluble basic systemic antacid is one which forms insoluble basic compound in the intestine and is not subsequently absorbed. So these antacids do not produce systemic alkalosis.e.g. Al (OH) 3, Ca (OH) 2 Mg (OH) 2, Ca3 (PO4) 2,Mg-trisilicate.Among these Al (OH) 3 Mg-trisilicate and Mg (OH) 2 are sometimes called buffer antacid as they do not raise the gastric PH even above neutrality.
A non- insoluble basic systemic antacid is one which forms insoluble basic compound in the intestine and is not subsequently absorbed. So these antacids do not produce systemic alkalosis.e.g. Al (OH) 3, Ca (OH) 2 Mg (OH) 2, Ca3 (PO4) 2,Mg-trisilicate.Among these Al (OH) 3 Mg-trisilicate and Mg (OH) 2 are sometimes called buffer antacid as they do not raise the gastric PH even above neutrality.
Formulla:
Formulla foer 100 ml antacid suspension:
Each 5 ml contains 300 mg of Al(OH)3 & 200 mg of Mg(OH)2
Formulla foer 100 ml antacid suspension:
Each 5 ml contains 300 mg of Al(OH)3 & 200 mg of Mg(OH)2
Name of the ingredient
|
Theoretical weight
|
Weighed amount
|
Al(OH)3
|
6 gm
| |
Mg(OH)2
|
4 gm
| |
Na–CMC
|
1 gm
| |
Glycerin
|
10 ml
| |
Sorbitol(70%)
|
10 ml
| |
Sodium Benzoate
|
0.5 gm
| |
Na- saccharin
|
20 mg
| |
Organic Oil
|
q.s
| |
Purified Water
|
q.s to 100 ml
|
Apparatus:
1. Beaker 3.Filter paper 5.Stirrer 7.Measuring cylinder 9. Electric balance
2.Mortar 4.Pestle 6. Funnel 8.Droppers
1. Beaker 3.Filter paper 5.Stirrer 7.Measuring cylinder 9. Electric balance
2.Mortar 4.Pestle 6. Funnel 8.Droppers
Method of Preparation:
1. 1gm of Sodium –CMC was taken in a mortar and small amount of water was added and triturated to produce fine mucilage3 with the help of pestle.
1. 1gm of Sodium –CMC was taken in a mortar and small amount of water was added and triturated to produce fine mucilage3 with the help of pestle.
2. Then 6 gm Al(OH)3 and 4 gm of Mg(OH)2 were taken in mortar and triturated .Then 10 ml sorbitol and 10 ml glycerin were adde3d in the mortar and triturated until fine smooth paste was produce.
3. 20 mg of Sodium –Saccharine and 0.5 gm of Sodium Benzoate were taken and dissolved in small amount of water and added to the mortar and triturated.
4. Organic oil was added and the preparation was triturated properly and it was taken in a measuring cylinder and volume was made unto 100 ml by the addition of sufficient quantity of water.
5. From the cylinder, the preparation was transferred in a well polished bottle. Then the bottle was corked and labeled.
Function of ingredients:
1.Al(OH)3 and Mg(OH)2:These are the active part of the preparation.They serve to reduce the acidity.
2. Na-CMC :
Properties:
i. it is white to faintly yellow in color
ii. odorless
iii. hygroscopic powder
iv. soluble in water & insoluble in organic solvents
v. It shows pseudo-plastic flow behavior.
Function:
i. As suspending agent
ii. viscosity imparting agent.
3. Glycerin:
Properties: i. Clear, colorless, odorless iii. Viscous
ii. Hygroscopic in nature iv. Sweet in taste
2. Na-CMC :
Properties:
i. it is white to faintly yellow in color
ii. odorless
iii. hygroscopic powder
iv. soluble in water & insoluble in organic solvents
v. It shows pseudo-plastic flow behavior.
Function:
i. As suspending agent
ii. viscosity imparting agent.
3. Glycerin:
Properties: i. Clear, colorless, odorless iii. Viscous
ii. Hygroscopic in nature iv. Sweet in taste
Functions:
♦Solvent, ♦Sweetening agent
♦Antimicrobial agent ♦Viscosity imparting agent
♦Solvent, ♦Sweetening agent
♦Antimicrobial agent ♦Viscosity imparting agent
4. Sorbitol :
Properties:
i. White or almost colorless crystalline, odorless, hygroscopic powder also available as
granule flakes and pellets to prevent caking.
ii. Pleasant, cooling, sweet taste ( 50-60 % the sweetness of sucrose )
iii. Melting point 110-112ºC ( anhydrous )
iv. Solubility : very soluble in water and soluble in warm alcohol and glycerin and slightly soluble in hydrocarbons.
v. Stability and storage conditions : sorbitol is relatively chemically inert and compatible
with most excipients.
vi . It is stable in air in the absence of catalysts and in colds dolutes acids and bases
vii. It is nonflammable noncorrosive and nonvolatile
viii.In high concentration Sorbitol is stabilizer for Labile Vitamins and antibiotics
ix . Since it is hygroscopic it should be stored in a tightly sealed container.
Funtions :
i . Sweetenening agent ( 25-90 % ) substitute for glycerin and propylene glycol
ii . Humactant ( 3-15 % )concentration
iii . Binder and moisture control agent ( 3-10 % ) in tablets
iv . Viscosity agent (25-90 % )
Properties:
i. White or almost colorless crystalline, odorless, hygroscopic powder also available as
granule flakes and pellets to prevent caking.
ii. Pleasant, cooling, sweet taste ( 50-60 % the sweetness of sucrose )
iii. Melting point 110-112ºC ( anhydrous )
iv. Solubility : very soluble in water and soluble in warm alcohol and glycerin and slightly soluble in hydrocarbons.
v. Stability and storage conditions : sorbitol is relatively chemically inert and compatible
with most excipients.
vi . It is stable in air in the absence of catalysts and in colds dolutes acids and bases
vii. It is nonflammable noncorrosive and nonvolatile
viii.In high concentration Sorbitol is stabilizer for Labile Vitamins and antibiotics
ix . Since it is hygroscopic it should be stored in a tightly sealed container.
Funtions :
i . Sweetenening agent ( 25-90 % ) substitute for glycerin and propylene glycol
ii . Humactant ( 3-15 % )concentration
iii . Binder and moisture control agent ( 3-10 % ) in tablets
iv . Viscosity agent (25-90 % )
5. Sodium saccharin : Used as sweetening agent.
6. Organic Oil : Used as Flavoring agent.
7. Purified Water : Used as Vehicle.
6. Organic Oil : Used as Flavoring agent.
7. Purified Water : Used as Vehicle.
Market preparation:
Trade Name Manufacturer Name
Entacyd Square
Lactameal Beximco
Alucil Opsonin
Oxecone Acme
Antanil Ibn sina
Experiment No : 05
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Date : 02.10.11
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Name Of The Experiment : Preparation of 60 ml Metronidazole suspension
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Introduction:
Metronidazole is the chemotherapeutic agent which is used in the treatment of infectious diseases caused by flagella and protozoa. It is the drug of choice in the most of amoebosis. It is originally introduced as an oral agent against Trichomonas organism and is also effective for both intestinal and extra intestinal form of disease.
Metronidazole is also available for oral therapy as 400 mg and as viginal tablet containing 500 mg. It is also available in suspension form. It is also sparingly soluble in water. When it is given as dispersed in liquid form, destroyed on long standing. Most commonly used metronidazole is benzoyl metronidazole, which is water soluble.
Metronidazole is adequately and rapidly absorbed from GIT. They cross the placenta barrier and are present on the milk. It is rapidly metabolized in the body and after large dosages; the metronidazole metabolites may impart a dark color to the urine.
Side-effects of Metronidazole:
‒ Gastrointestinal symptoms
‒ Stomatitis
‒ Disulphiram like reaction with ethanol
‒ A change in urine color and nearly neuropathy
‒ It should not be used during pregnancy.
Formula:
For 60 ml Metronidazole suspension:
Each 5 ml contain 320 mg of benzoyl metronidazole.
Metronidazole is the chemotherapeutic agent which is used in the treatment of infectious diseases caused by flagella and protozoa. It is the drug of choice in the most of amoebosis. It is originally introduced as an oral agent against Trichomonas organism and is also effective for both intestinal and extra intestinal form of disease.
Metronidazole is also available for oral therapy as 400 mg and as viginal tablet containing 500 mg. It is also available in suspension form. It is also sparingly soluble in water. When it is given as dispersed in liquid form, destroyed on long standing. Most commonly used metronidazole is benzoyl metronidazole, which is water soluble.
Metronidazole is adequately and rapidly absorbed from GIT. They cross the placenta barrier and are present on the milk. It is rapidly metabolized in the body and after large dosages; the metronidazole metabolites may impart a dark color to the urine.
Side-effects of Metronidazole:
‒ Gastrointestinal symptoms
‒ Stomatitis
‒ Disulphiram like reaction with ethanol
‒ A change in urine color and nearly neuropathy
‒ It should not be used during pregnancy.
Formula:
For 60 ml Metronidazole suspension:
Each 5 ml contain 320 mg of benzoyl metronidazole.
Name of ingredient
|
Theoritical wt.
|
wt. of amount
|
Benzoyl Metronidazole
|
3.84 gm
| |
Na-CMC
|
0.5 gm
| |
Sugar syrup
|
10 ml
| |
Na-Saccharine
|
20 mg
| |
Glycerin
|
5 ml
| |
Tween-80
|
0.06 ml
| |
Na-Benzoate
|
0.5 gm
| |
Organic flavor
|
q.s
| |
Organic red color
|
q.s
| |
Distilled water
|
q.s upto 60 ml
|
Apparatus:
1. Beakers 3. Measuring cylinder 5. Filter paper 7.Master & pestle
2. Funnel 4.Pipette 6. Bottle 8.Electric balance
1. Beakers 3. Measuring cylinder 5. Filter paper 7.Master & pestle
2. Funnel 4.Pipette 6. Bottle 8.Electric balance
Method of preparation:
1. In a clean & dry mortar, 0.5 gm of Na-CMC was taken and small amount of water was added and
allowed for proper swelling to form the mucilage.
2. 3.84 gm of benzoyl metronidazole was taken in a beaker and dissolved in some purified water with
proper stirring.
3. This Metronidazole solution was added to the mortar and triturated with few drops of tween-80.
4. Then 0.5 gm of Na-benzoate and 20 mg of Na-saccharine was added and triturated.
5. 10 ml sucrose syrup and 5 ml glycerin were added and stirred to form proper homogeneous
product.
6. Then the organic flavor and color were added and mixed properly.
7. The whole content of mortar was transferred to the measuring cylinder the volume was adjusted to
60 ml by the addition of water.
8. The preparation was transferred in an amber glass bottle since the metronidazole is light sensitive.
The bottle was properly closed and labeled.
Functions of each ingredient:
1. Bezoyl Metronidazole : It is the active ingredient of the preparation. It is used in the treatment of infection caused by protozoa & flagella.
2. Na-CMC :
Properties:
i. it is white to faintly yellow in color. iv.hygroscopic powder
ii. Odorless v. It shows pseudo-plastic flow behavior.
iii. soluble in water & insoluble in organic solvents.
Function:
i. As suspending agent ii. viscosity imparting agent
.
3. Sucrose syrup :
Properties:
i. Colorless or Brown , Odorless, Crystalline Powder.
ii. It has a sweet taste.
iii. Free flowing (crystalline sucrose)
iv. Cohesive solid (Powder Sucrose)
v. Melting Point 168-186 º C
vi. Good stability at room temperature and at moderate relative humidity.
vii. Diluents solutions are liable to attack by microorganisms.
viii.Sucrose is considered to be more carcinogenic than other carbohydrates because it is more easily converted to dental plaque.
ix. Viscous in nature.
x. Concentration is 67% w/v
Functions:
i. As Sweetening Agent ii. Viscosity increasing agent.
1. In a clean & dry mortar, 0.5 gm of Na-CMC was taken and small amount of water was added and
allowed for proper swelling to form the mucilage.
2. 3.84 gm of benzoyl metronidazole was taken in a beaker and dissolved in some purified water with
proper stirring.
3. This Metronidazole solution was added to the mortar and triturated with few drops of tween-80.
4. Then 0.5 gm of Na-benzoate and 20 mg of Na-saccharine was added and triturated.
5. 10 ml sucrose syrup and 5 ml glycerin were added and stirred to form proper homogeneous
product.
6. Then the organic flavor and color were added and mixed properly.
7. The whole content of mortar was transferred to the measuring cylinder the volume was adjusted to
60 ml by the addition of water.
8. The preparation was transferred in an amber glass bottle since the metronidazole is light sensitive.
The bottle was properly closed and labeled.
Functions of each ingredient:
1. Bezoyl Metronidazole : It is the active ingredient of the preparation. It is used in the treatment of infection caused by protozoa & flagella.
2. Na-CMC :
Properties:
i. it is white to faintly yellow in color. iv.hygroscopic powder
ii. Odorless v. It shows pseudo-plastic flow behavior.
iii. soluble in water & insoluble in organic solvents.
Function:
i. As suspending agent ii. viscosity imparting agent
.
3. Sucrose syrup :
Properties:
i. Colorless or Brown , Odorless, Crystalline Powder.
ii. It has a sweet taste.
iii. Free flowing (crystalline sucrose)
iv. Cohesive solid (Powder Sucrose)
v. Melting Point 168-186 º C
vi. Good stability at room temperature and at moderate relative humidity.
vii. Diluents solutions are liable to attack by microorganisms.
viii.Sucrose is considered to be more carcinogenic than other carbohydrates because it is more easily converted to dental plaque.
ix. Viscous in nature.
x. Concentration is 67% w/v
Functions:
i. As Sweetening Agent ii. Viscosity increasing agent.
4. Glycerin:
Properties: i. Clear, colorless, odorless iii. Viscous
ii. Hygroscopic in nature iv. Sweet in taste
Properties: i. Clear, colorless, odorless iii. Viscous
ii. Hygroscopic in nature iv. Sweet in taste
Functions:
♦Solvent, ♦Sweetening agent
♦Antimicrobial agent ♦Viscosity imparting agent
♦Solvent, ♦Sweetening agent
♦Antimicrobial agent ♦Viscosity imparting agent
5. Na-saccharine : as sweetening agent.
6. Na-benzoate : used as preservative.
7. Tween-80 : Wetting agent.
8. Flavoring agent : Organic flavor: It is used as flavoring agent.
9. Organic red flavor : It is used as coloring agent.
10. Distilled water : Used as vehicle.
6. Na-benzoate : used as preservative.
7. Tween-80 : Wetting agent.
8. Flavoring agent : Organic flavor: It is used as flavoring agent.
9. Organic red flavor : It is used as coloring agent.
10. Distilled water : Used as vehicle.
Indication:
1. It is used as in the treatment of infectious disease caused by protozoa & flagella.
2. It is used in the treatment of dysentery.
Market preparation:
Trade Name Manufacturer Name
Amodis Square
Filmet Beximco
Metryl Opsonin
Metco Eskayef
Amotrex ACI
1. It is used as in the treatment of infectious disease caused by protozoa & flagella.
2. It is used in the treatment of dysentery.
Market preparation:
Trade Name Manufacturer Name
Amodis Square
Filmet Beximco
Metryl Opsonin
Metco Eskayef
Amotrex ACI
Experiment No : 06
|
Date : 02.10.11
|
Name Of The Experiment:Preparation of 100 ml oil in water (o/w) emulsion
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Introduction:
An emulsion may be defined as a biphasic liquid dosage form of medicament in which two immiscible liquids are made miscible by the addition of third substance known as emulsifying agent.
In other word, an emulsion may also be defined as a mixture of two immiscible liquid in which one this is dispersed as small globules or droplets into another.
Emulsion is widely used in pharmacy and medicine. They are made internally as well as externally, certain medicinal agent having an unpleasant taste & odor can be made more palatable for oral administration in the form of emulsion The activity of certain drugs can be increased & action can be prolonged by emulsifying the drug in a suitable vehicle.
Classification of Emulsion:
There are two types of emulsion
a) oil in water(o/w) type emulsion and
b) water in oil(w/o) type emulsion
a) Oil in water (o/w) type emulsion:
In oil in emulsion, the oil is the dispersed phase and water is the dispersion medium. This type
of emulsion is preferable or preferred for internal use because the unpleasant taste & odor is masked by emulsification.
b) Water in oil (w/o) type emulsion:
In water in oil emulsion, the water is the dispersed phase and oil is the dispersion medium. This type of emulsion is mainly used externally.
According to the consistence:
a) Liquid emulsion : They are generally oil in water emulsion and they are used orally, parentally and externally. e.g.lotion, ointment.
b) Semi-solid emulsion : They are both o/w and w/o type of emulsion. They are used as internally and externally . e.g. cream
An emulsion may be defined as a biphasic liquid dosage form of medicament in which two immiscible liquids are made miscible by the addition of third substance known as emulsifying agent.
In other word, an emulsion may also be defined as a mixture of two immiscible liquid in which one this is dispersed as small globules or droplets into another.
Emulsion is widely used in pharmacy and medicine. They are made internally as well as externally, certain medicinal agent having an unpleasant taste & odor can be made more palatable for oral administration in the form of emulsion The activity of certain drugs can be increased & action can be prolonged by emulsifying the drug in a suitable vehicle.
Classification of Emulsion:
There are two types of emulsion
a) oil in water(o/w) type emulsion and
b) water in oil(w/o) type emulsion
a) Oil in water (o/w) type emulsion:
In oil in emulsion, the oil is the dispersed phase and water is the dispersion medium. This type
of emulsion is preferable or preferred for internal use because the unpleasant taste & odor is masked by emulsification.
b) Water in oil (w/o) type emulsion:
In water in oil emulsion, the water is the dispersed phase and oil is the dispersion medium. This type of emulsion is mainly used externally.
According to the consistence:
a) Liquid emulsion : They are generally oil in water emulsion and they are used orally, parentally and externally. e.g.lotion, ointment.
b) Semi-solid emulsion : They are both o/w and w/o type of emulsion. They are used as internally and externally . e.g. cream
According to the route of administration:
a) Emulsion for internal use and b) Emulsion for external use
According to the particle size:
a) coarse emulsion
b) fine emulsion
c) micro emulsion
a) Emulsion for internal use and b) Emulsion for external use
According to the particle size:
a) coarse emulsion
b) fine emulsion
c) micro emulsion
Preparation of Emulsion:
For small scale preparation, emulsion can be prepared by the following method:
a) Dry gum method b) Wet gum method c) Bottle method
The proportion of oil, water and gum acacia required for fixed oil and volatile oil for the preparation of primary emulsion are-
Name of the oil – Rose oil : water : gum
Fixed oil – 4 : 2 : 1
Volatile oil – 4 : 4 : 2
For small scale preparation, emulsion can be prepared by the following method:
a) Dry gum method b) Wet gum method c) Bottle method
The proportion of oil, water and gum acacia required for fixed oil and volatile oil for the preparation of primary emulsion are-
Name of the oil – Rose oil : water : gum
Fixed oil – 4 : 2 : 1
Volatile oil – 4 : 4 : 2
Formula as Recipe:
Each 5 ml contain 0.5 ml of castor oil
Each 5 ml contain 0.5 ml of castor oil
Name of ingredient
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Theoritical wt.
|
wt. of amount
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Castor oil
|
10 ml
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Acacia
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2.5 gm
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Sugar syrup
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10 ml
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Methyl paraben
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0.2 gm
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Sorbitol
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10 ml
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Rasberry oil
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1-2 drops or q.s
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Distilled water
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q.s to 100 ml
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Apparatus:
1. Mortar and pestle 3. Bottle 5. Filter papers 7. Droppers
2. Beakers 4. Measuring cylinders 6. Funnel 8. Stirrers
1. Mortar and pestle 3. Bottle 5. Filter papers 7. Droppers
2. Beakers 4. Measuring cylinders 6. Funnel 8. Stirrers
Method of preparation:
1. Thoroughly cleaned and dry mortar and pestle was taken and 2.5 mg acacia was weighed and
transferred to the mortar.
2. Acacia was triturated by adding small quantity of water slowly to form mucilage.
3. This 10 ml castor oil was added in a small quantity with rapid trituration until a clicking sound is
produced and the product become white or nearly white. At this stage, the emulsion is known as
primary emulsion. Then methyl paraben is added to the emulsion.
4. Then about 10 ml sugar syrup and 10 ml sorbitol were added in small quantities at a time with
constant
trituration respectively so as to get and homogeneous product.
5. The emulsion is transferred to a measuring cylinder and more of vehicle is added to produce the
final volume 100 ml and stirred. Then form a uniform emulsion. The preparation is transferred to a
bottle, closed properly an
Functions of ingredient:
1. Castor oil : It is the active ingredient of the preparation. It acts as a laxative.
2. Acacia : It is used as an emulsifying agent or viscosity enhancing agent.
3. Sucrose syrup & : These is used in the preparation as sweeting agent to mask the
Na-Saccharine bitter taste of preparation.
Sucrose syrup:
Properties:
i. Colorless or Brown , Odorless, Crystalline Powder.
ii. It has a sweet taste.
iii. Free flowing (crystalline sucrose)
iv. Cohesive solid (Powder Sucrose)
v. Melting Point 168-186 º C
vi. Good stability at room temperature and at moderate relative humidity.
vii. Diluents solutions are liable to attack by microorganisms.
viii.Sucrose is considered to be more carcinogenic than other carbohydrates because it is
more easily converted to dental plaque.
ix. Viscous in nature.
x. Concentration is 67% w/v
Functions:
i. As Sweetening Agent ii. Viscosity increasing agent.
i. As Sweetening Agent ii. Viscosity increasing agent.
4. Sorbitol :
Properties :
i . White or almost colorless crystalline, odorless, hygroscopic powder also available as
granules, flakes and pellets to prevent caking.
ii . Pleasant, cooling, sweet taste ( 50-60 % the sweetness of sucrose )
iii. Melting point 110-112ºC ( anhydrous )
iv . Solubility : very soluble in water and soluble in warm alcohol and glycerin and slightly
soluble in hydrocarbon
v . Stability and storage conditions : sorbitol is relatively chemically inert and compatible with most excipients.
vi . It is stable in air in the absence of catalysts and in colds dolutes acids and bases
vii .It is nonflammable noncorrosive and nonvolatile
viii.In high concentration Sorbitol is stabilizer for Labile Vitamins and antibiotics
ix . Since it is hygroscopic it should be stored in a tightly sealed container.
Funtions :
i . Sweetenening agent ( 25-90 % ) substitute for glycerin and propylene glycol
ii . Humactant ( 3-15 % )concentration
iii . Binder and moisture control agent ( 3-10 % ) in tablets
iv . Viscosity agent (25-90 % )
Properties :
i . White or almost colorless crystalline, odorless, hygroscopic powder also available as
granules, flakes and pellets to prevent caking.
ii . Pleasant, cooling, sweet taste ( 50-60 % the sweetness of sucrose )
iii. Melting point 110-112ºC ( anhydrous )
iv . Solubility : very soluble in water and soluble in warm alcohol and glycerin and slightly
soluble in hydrocarbon
v . Stability and storage conditions : sorbitol is relatively chemically inert and compatible with most excipients.
vi . It is stable in air in the absence of catalysts and in colds dolutes acids and bases
vii .It is nonflammable noncorrosive and nonvolatile
viii.In high concentration Sorbitol is stabilizer for Labile Vitamins and antibiotics
ix . Since it is hygroscopic it should be stored in a tightly sealed container.
Funtions :
i . Sweetenening agent ( 25-90 % ) substitute for glycerin and propylene glycol
ii . Humactant ( 3-15 % )concentration
iii . Binder and moisture control agent ( 3-10 % ) in tablets
iv . Viscosity agent (25-90 % )
5. Methyl paraben : It is used as a preservative.
6. Raspberry oil : as a flavoring agent.
7. Distilled water : It is used as a vehicle.
Other ingredients that can be used :
♦Active ingredients : Arachid oil can be used.
♦Emulsifying agent : Agar, tragacanth, and starch
♦Sweetening agent : Sucrose can be used.
♦Preservative : Na-benzoate and propyl paraben.
♦Flavoring agent : Peppermint oil, lemon oil and clove oil can be used.
Starch is used as binder ; diluent and disintegrant :
As a diluent : Starch is used for the preparation of standardized triturates of colourants or potent drugs to facilitate sunbsequent mixing or blending processes in manufacturing operations, formulation for volume adjustment of the fill matrix.
6. Raspberry oil : as a flavoring agent.
7. Distilled water : It is used as a vehicle.
Other ingredients that can be used :
♦Active ingredients : Arachid oil can be used.
♦Emulsifying agent : Agar, tragacanth, and starch
♦Sweetening agent : Sucrose can be used.
♦Preservative : Na-benzoate and propyl paraben.
♦Flavoring agent : Peppermint oil, lemon oil and clove oil can be used.
Starch is used as binder ; diluent and disintegrant :
As a diluent : Starch is used for the preparation of standardized triturates of colourants or potent drugs to facilitate sunbsequent mixing or blending processes in manufacturing operations, formulation for volume adjustment of the fill matrix.
As a binder : In tablet formulation prepared starch paste is used at a conc. of 5-25 % w/w in tablet granulation as a binder.
As a disintegrant : Starch is one of the most commonly used tablet disintegrant at conc.of 3-15 % w/w . In granulated formulation about half of the total starch content is included in the granulation mixture and the balance of the final blend with the dried granulation.
Importance of emulsion in pharmacy and medicine:
1. The activity of certain drugs can be increased and action can be prolonged by emulsifying the drug
in a suitable vehicle.
2. Certain medicinal agent having the unpleasant odor and taste can be more palatable for oral
administration in the form of emulsion.
1. The activity of certain drugs can be increased and action can be prolonged by emulsifying the drug
in a suitable vehicle.
2. Certain medicinal agent having the unpleasant odor and taste can be more palatable for oral
administration in the form of emulsion.
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