Pharmaceutics II, LAB MANUAL

KINGDOM OF SAUDI ARABIA

PRINCE SATTAM BIN ABDULAZIZ

COLLEGE OF PHARMACY

LABORATORY MANUAL

PHARMACEUTICS II

PHT-312

LEVEL V

Lab Co-ordinator

Dr. Shahid Jamil

Email:-


Contents

Week / Experiment, Exercise & Preparation / QC/Lab discipline (5) / Lab Indiscipline
(-5) / LAB RECORD (5) / Page no
Introduction
1 / Introduction of preparation of pharmaceuticals solution, glass ware etc.
Aqueous Pharmaceutical Solutions
2 / 1.  To prepare and submit 50 ml of concentrated peppermint water BP/ chloroform water BP 0.25 %
3 / 2.  To prepare and submit 60 ml of gargles.
Non aqueous pharmaceutical solution
4 / 3.  To prepare and submit 20 ml of elixirs as non-aqueous preparation.
4.  To prepare and submit 50 ml of glycerides by using given formula.
Sweet & Viscid Pharmaceutical Solutions
5 / 5.  To prepare and submit 20 ml of simple syrups by using given formula.
Pharmaceutical Emulsions
6 / 6.  To determine emulsifying agent on the basis of HLB value of surfactant
7.  To prepare and submit 20 ml of mineral oil emulsion
7 / 8.  To prepare and submit 20 ml of castor oil emulsion
Pharmaceutical Suspensions and colloids
8 / 9.  To prepare and submit 50 ml of barium sulfate suspension. Suspension
10.  To prepare and submit 50 ml of antacid suspension.
9 / 11.  To prepare and determine the sedimentation rate of magnesium hydroxide suspension and effect of electrolyte on degree of flocculation.
Preparation of lotions
11 / 12.  To prepare and submit 10 ml of calamine lotion.
13.  To prepare and submit 10 ml of scalp lotion.
Semisolid dosage form
12 / 14.  To prepare and submit 10 g of toothpaste.
15.  To prepare and submit 10 g of zinc oxide paste.
13 / 16. To prepare and submit 10 g of vicks ointment (10%)
17 To prepare and submit 10 g of zinc oxide ointment.

Note: All grading should be accompanied by signature of Lab instructor.

Note 2: Lab record must be checked on or before next experiment. (Late submission means losing 1 grade/day)

Note 3: Final Lab exam (10) + viva/ synopsis/ other activities/ (5)

Lab Indiscipline (-5)

St Name / Attendance / Late entry
(-1) / No lab coat
(-1) / Lab Indiscipline
(-1) / Dirty
Workplace (-1) / Dirty
Glass wares (-1)

Note: This form is to be kept with Lab instructor


INTRODUCTION

Solutions

Simple solutions (containing soluble substances only)

General Method

Stage [1]

·  Dissolve the solids in about three quarter of the vehicle;

Substances in list A: simply add the material, without previous powdering, to the vehicle in a measure, and stir until dissolved.

Substances in list B: finely powder the material in a mortar, add the vehicle, and stir until dissolved.

·  Then transfer the solution to a measure, rinse the mortar with a small quantity of vehicle, and add to the contents of the measure.

The term "vehicle" is used to denote the liquid in which the medicinally-active ingredients are dissolved or suspended. The vehicle may be inert (e.g. water), or a flavoring agent (peppermint water), or a preserving and sweetening agent (e.g. chloroform water), or it may have some medical property (e.g. in fusion of senna).

Three quarters of the vehicle is selected as a suitable proportion for stage 1, for the following consideration.

(a) The volume occupied by the other ingredients will rarely exceed the remaining one-quarter, but, if it should, the quantity of vehicle used in stage 1 must be reduced.

(b) Solution is accelerated by using as much of the solvent.

Stage [2]

Examine the solution critically by holding it against the light. If particles of foreign matter are visible, strain the solution through a plug of cotton-wool placed in a funnel, and when the solution has passed through, pour a little of the aqueous vehicle on the wool.

Stage [3]

Add any liquid ingredients. After measuring each, rinse the vessel used with little of the aqueous vehicle, and add to the contents of the measure.

The vehicle used in stage 1 may have been heated to facilitate solution of the solid. In each case the liquid must be thoroughly cooled before the addition of any liquid containing a volatile substance. Further, the succeeding stages 4 and 5 must be completed as quickly as possible, to minimize loss by volatilization from the open measure.

Practically, it is preferable to adjust the mixture to volume minus the volume of the volatile liquid, transfer to the bottle, add the volatile liquid, and cap immediately.

Stage [4]

Add more of the vehicle to produce the prescribed volume.

Adjustment to volume should be made in a graduated measure, because of the frequent discrepancy between the supposed and actual capacity of dispensing bottles.

·  The stirrer must, of course, be removed from the measure before adjusting to volume.

Stage [5]

Transfer the mixture (solution) to the bottle; cork, and then thoroughly polish the bottle to remove finger-marks. Attach the label.

Soluble substances

A number of water-soluble substances in common use appears in the following lists. Some of these substances are much less than others, but they are administered in smaller doses, or in weaker solutions, so that, as ordinarily prescribed they will dissolve.

List [A]

a- Substances that are readily dissolved with stirring:

Ammonium bicarbonate. Ammonium chloride.

Atropine sulfate. Calcium chloride.

Chloral hydrate. Citric acid,

Dextrose monohydrate. Ephedrine hydrochloride.

Hyoscine hydrobromide. Iron ammonium citrate.

Phenobarbitone sodium. Phenol.

Potassium citrate. Potassium iodide.

Potassium Permanganate. Sodium benzoate.

Sodium bicarbonate. Sodium bromide.

Sodium carbonate. Sodium chloride.

Sodium citrate. Sodium iodide.

Sodium metabisulphate. Sodium potassium tartrate.

Sodium salicylate. Tannic acid.

Zinc sulfate.

b- Substances that dissolve more readily in warm water.

Magnesium sulphate. Phenazone.

Sodium acid phosphate. Sodium sulfate.

List [B]

Substances that do not readily dissolve unless finely powdered in a mortar before the aqueous vehicle are added.

·  Alum. Borax.

·  Boric acid. Calcium lactate

·  Ferrous sulfate. Sodium phosphate.


Name of the glass ware used in pharmaceutics

(A) Glass rod (B) Beaker (C) Measuring cylinder (graduated)

( D) Conical flask (E) Mortar / pestle (F) Funnel

(G) Dispensing bottle

(G) Ointment and chemical Spatula (H) Graduated pipettes


AQUEOUS PHARAMACEUTICAL SOLUTIONS

AROMATIC WATERS:

·  Aromatic waters are medicated waters.

·  They are clear, saturated aqueous solutions of volatile oils.

·  They used as flavoring vehicles in pharmaceuticals and cosmetics or as carminative agent.

Example: Chloroform water, camphor water, peppermint, orange and rose water.

Due to salting out of certain ingredients such as soluble salts the preparations of the formulation having aromatic water showed some problem. Replacement of part of the aromatic water with purified water is the solution of this problem.

Storage: Must be stored in airtight light-resistant containers.

Method of preparation:

Dissolution: these methods are simpler, quicker and more economical as compare to distillation.

According to the method recommended in I.P. the corresponding essential oil from which the aromatic water is to be prepared, should be shaken with 500 times its volume of purified water. Shaking is repeated several times during a period of about thirty minutes. The mixture is then set aside overnight and clarifies by filtration. For e.g. chloroform water.

Another dissolution method consists of incorporating 2 ml of volatile oil or 2 g suitably comminuted aromatic solid with 15 g of powdered talc or sufficient quantity of kieselghur or pulp filter paper. 1000 ml of purified water is added to this mixture and the resulting slurry is thoroughly agitated several times for about 10 min and filtered. More purified water is passed through the filter paper to make up the volume.

Powdered talc, kieselghur pulp filter paper and purified siliceous earth serve two purposes. They act as filter aid and render the product more clear and as distributing agent for aromatic substances.

EXPERIMENT NO: 1

AIM: To prepare and submit 50 ml of concentrated peppermint water BP.

Apparatus: Beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod.

Materials: peppermint oil, alcohol (ethanol), purified water.

Formula:

Rx

Peppermint oil 20 ml

Alcohol (90%) 600 ml

Purified water q.s 1000 ml

Procedure:

Peppermint oil is dissolved in alcohol. Sufficient purified water is then added in successive portions, shaking vigorously after each addition. Final volume is then made up with more purified water. However, purified talc or other filtering aid may be added and the mixture shaken occasionally for a few hours and finally filtered.

Storage: it should be stored in well closed container, in a cool place.

Dose: 0.3 to 1 ml.

Theory: main active constituent of peppermint oil are methyl acetate, an ester and free menthol.

Practical Lab Report

Name of Experiment:

Date:

AIM:

Ingredient used and their function:

Calculations:

Observations & Results:

Indication:

EXPERIMENT NO: 2

AIM: To prepare and submit 50 ml of chloroform water BP 0.25 %.

Apparatus: Beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod.

Materials: chloroform, purified water.

Formula:

Rx

Chloroform 2.5 ml

Purified water up-to 1000 ml

Procedure:

Chloroform (0.1 ml) is dissolved by shaking in purified water sufficient to produce 50 ml.

Note: Chloroform is slightly soluble (1: 200 at 20º C) in water.

Storage: it should be stored in well closed container, in a cool place. Chloroform water should be protected from light.

Dose: 15 to 30 ml.

Use: vehicle and preservative.

Practical Lab Report

Name of Experiment:

Date:

AIM:

Ingredient used and their function:

Calculations:

Observations & Results:

Indication:

GARGLES:

Gargles are aqueous solutions used for treating the pharynx and nasopharynx by forcing air from the lungs through the gargle which is held in the throat.

EXPERIMENT NO: 3

AIM: To prepare and submit 60 ml of gargles preparation by using following formula.

Apparatus: Beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod.

Materials: phenol, menthol, glycerin, boric acid.

Formula:

Rx
Phenol (1%) / 1.0 ml
Menthol (1%) / 0.5 ml
Glycerin / 15 ml
Boric acid solution (1.5%) ad / 120 ml
Mitte: 60 ml.
Sig.: dil. ut dict.(dilute as per direction)

Procedure:

Menthol is dissolved in 1 ml. of alcohol; with stirring add the phenol and glycerin dissolved in the boric acid solution. A clear solution will formed.

Practical Lab Report

Name of Experiment:

Date:

AIM:

Ingredient used and their function:

Calculations:

Observations & Results:

Indication:

NON AQUEOUS PHARMACEUTICAL SOLUTION

ELIXIRS:

Elixirs are clear, pleasantly flavored, sweetened hydro- alcoholic liquids intended for oral use. They are used as flavors and vehicles for drug substances and when such substances are incorporated into the specified solvents, they are classified as medicated elixirs. The main ingredients in the elixir are ethanol and water but glycerin, sorbitol and propylene glycol, flavoring agents, preservatives and syrups are often used in the preparation of the final products.

The alcoholic content of elixirs varies greatly from elixirs, only a small quantity to those that contains a considerable portion as a necessary aid to solubility.

For example; Aromatic Elixir USP contains 21 – 23% ethanol;

Compound benzaldehyde elixir NF contains 3 - 5% ethanol.

Elixirs may also contain glycerin and syrup. These may be added to increase the solubility of the medicinal agent or for sweetening purpose. Some elixirs contain propylene glycol. This solvent is a satisfactory substitute for both glycerin and ethanol.

Sucrose increase viscosity and decreases the solubilizing properties of water and so must be added after primary solution has been carried out.

A high alcoholic content is maintained during preparation by adding the aqueous phase to the alcoholic solution.

Elixirs should always be brilliantly clear. They may be strained or filtered and if necessary, subjected to the clarifying action of purified talc or siliceous earth.

EXPERIMENT NO: 4

AIM: To prepare and submit 10 ml of elixirs as non-aqueous preparation.

Apparatus: Beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod.

Materials: compound orange spirit, alcohol, glycerin, sucrose, purified water.

Formula:

Rx
Compound orange spirit / 10 ml.
Alcohol / 100 ml.
Glycerin / 200 ml.
Sucrose / 320 g.
Purified water, q.s. / 1000 ml.

Ft.: elix.

Procedure:

1)  Take three quarter of water, warm on hot plate dissolve the sucrose into this warm water.

2)  Mix the alcohol, glycerin, to it.

3)  Filter the solvent mixture through a hard filter paper, returning, if necessary, the first portions of the filtrate until it passes through clear.

4)  Add enough of vehicles make the volume upto10 ml.

Note (Alcohol content: 8 - 10 %)

Practical Lab Report

Name of Experiment:

Date:

AIM:

Ingredient used and their function:

Calculations:

Observations & Results:

Indication:

GLYCERITES:

Glycerites are solutions or mixtures of medicinal substances are not less than 50% by wt glycerin. Most of glycerites are extremely viscous and some of them are of a jelly-like consistency.

The advantages of glycerin in these preparations are:

1)  A valuable solvent, being composed of a polar and non-polar groups, it has a wide range of solvent power.

2)  Its sweet taste.

3)  Has a preservative action.

4)  Stable.

5)  Miscible with water and alcohol, thus liquid glycerites can serve as stoke solution

which may be diluted with water or alcohol.

EXPERIMENT NO: 5

AIM: To prepare and submit 50 ml of scar phenol ear drops by using following formula.

Apparatus: Beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod.

Materials: phenol, glycerin.

(A)  To prepare 50 ml of Phenol Glycerin BPC

Phenol Glycerin BPC

Rx

Phenol 160 g

Glycerin 840 g

Density: Phenol = 1.07 g/cm3, Glycerin = 1.261 g/cm3

Procedure: Dissolve phenol in glycerin

(B) Scar Phenol ear drops BPC

Rx

Phenol glycerin 15 ml

Glycerin up-to 50 ml

Ft.: liq.

Sig: gtt. au

Procedure: Take the measured amount of phenol glycerin and diluted with sufficient amount of glycerin up to 50 ml.

Uses: used as antiseptic Ear drops

Storage: store in tightly closed container

Dose: 2-3 drops, three times in a day to each ear.

Theory:

Precautions

·  The ear should not be damp.

·  Water should not be added to this preparation. It reacts with phenol to produce a preparation which is caustic, and consequently, damaging the area of application.