PRACTICAL LAB MANUAL LAB MANUAL PHARMACEUTICs ii D.Pharm 2nd year 1Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 NDEX S.No 1 Name of experiments Introduction of preparation of pharmaceuticals solution, glass ware etc. To prepare and submit 50 ml of concentrated peppermint water BP 0.25 % To prepare and submit 20 ml of simple syrups by using given formula. To prepare and submit 20 ml of castor oil emulsion To prepare and submit 10 ml of calamine lotion. To prepare and submit 10 g of zinc oxide paste. To prepare and submit 10 g of zinc oxide ointment. To prepare and submit 60 ml of gargles. Prepare and supply 50 ml Dill Water Concentrated ILP. 1966. 2 3 4 5 6 7 8 9 water BP/ chloroform To prepare and submit 20 ml of elixirs as non-aqueous preparation To prepare and submit 50 ml of scar phenol ear drops by using following formula. To prepare and submit 50 ml of barium sulfate suspension. Suspension To prepare and submit 50 ml of antacid suspension. To prepare and determine the sedimentation rate of magnesium hydroxide suspension and effect of electrolyte on degree of flocculation Prepare and supply 50 gm Tooth Powder Prepare granules for 100 tablets of Calcium Lactate I.P. 1966 and compress 30 tablets each contains.100 mg of Calcium Lactate. 10 11 12 13 14 15 16 17 2Page Prepare and supply 5 ampoules of 5 ml each of Sodium Chloride Injection I.P. 1966. DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Name of the glass ware used in pharmaceutics (A) Measuring cylinder (graduated (E) Mortar / pestle (B) Beaker (D) Conical flask (C)) Glass rod (F) Funnel (G) Dispensing bottle (G) Ointment and chemical Spatula 3Page (H) Graduated pipettes DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 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: Distillation, dissolution and alternate solution. Dissolution 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 clearer and as distributing agent for aromatic substances. 4Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 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. Formula: Pippermint oil : 1 ml Alcohol (90%) : 30 ml Purified water qs : 50 ml Uses: carminative Dose : 0.3-1 ml Secondary Label: shake well before use Storage : Store in tight closed container , in cool place. Batch No: A-301 Date of Manufacturing: Date of Expiry: Manufactured By: Your name or ID no 28-Sep-11 5Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 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. 6Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 EXPERIMENT NO: 3 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 throax. 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. 7Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 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. 8Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 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 Sucrose Purified water, q.s. 200 ml. 320 g. 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 %) 9Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 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 Vol(ml) Mass/ density 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 dropsBPC Rx Phenol glycerin 15 ml Glycerin up-to 50 ml Fiat=ft=make Guttae=gtt=drops Au=ear Ft.: liq. Sig: gtt. au Procedure: Take the measured amount of phenol glycerin and diluted with sufficient amount of glycerin up to 50 ml. 10Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 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. 11Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Experiment No. 6 Object Prepare and supply 50 ml Dill Water Concentrated ILP. 1966. I.P. formula Dill oil 20 ml Alcohol (90 per cent) 600 ml Purified water, sufficient to produce 1000 ml Procedure Dissolve the dill oil in the alcohol (90 per cent). Add sufficient purified water in successive Sma th vigorous shaking after cach addition. to produce io00 ml. Add 50 gm purified talc, shake and set aside for a few hours, shake occasionally and filter. Storage Store in a well-closed container. Category Carminative. Flavouring agent. Dose 0.3 to 1.0 ml. Uses Dill water, concentrated, is used as carminative and flavouring agent. Due to this reason it Is commonly used in gripe waters. Explanation Concentrated aromatic waters contain alcohol as solvent. The oil is not soluble in water but it is freely soluble in alcohol (90 percent) i.e. in equal volumes of alcohol 90 per cent. So firstly the oil is dissolved in alcohol 90 percent and then purified water is added. Upon addition of water, the non-aromatic terpenes present in the oil are precipitated. Therefore vigorous shaking during each addition of water is necessary to dissolve any of the aromatic portion of oil that is temporarily precipitated. Purified talc or French chalk is used as an absorbent. The preparation is allowed to stand for a few hours to allow the finely divided globules of oil to coalesce and occasional shaking is done to facilitate the absorption of undissolved oil by the purified talc. Many of the volatile oils possess aromatic odour and taste due to the presence of aromatic substances in it which constitute only a very small part of the oil whereas the remainder is non-aromatic. The aromatic part is much more soluble in alcohol than the non-aromatic part containing insoluble terpenes. When alcoholic solution of a volatile oil is added to water the non-aromatic portion gets precipitated which is removed with purified talc by filtration. This preparation contains volatile oil so to prevent the volatilization of the volatile oil it should be stored in a well-closed container. . 12Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 SWEET & VISCID PHARMACEUTICAL SOLUTIONS SYRUPS: Syrups are concentrated solutions of a sugar such as sucrose in water or other aqueous liquids. When purified water alone is used in making the solution of sucrose, the preparation is known as syrup, or simple syrup. In addition to sucrose, certain other polyols, such as glycerin or sorbitol, may be added to retard crystallization of sucrose or to increase the solubility of added ingredients. When the aqueous preparation contains some added medicinal substance, the syrup is called medicated syrup. Flavored syrup is one which is usually not medicated, but which contains various aromatic or pleasantly flavored substances and is intended to be used as a vehicle or a flavor for prescriptions. EXPERIMENT NO: 7 AIM: To prepare and submit 10 ml of simple syrups B.P, by using following formulas. Apparatus: Beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod. Materials: sucrose, water. Formula: Rx Sucrose 66.7 g Water to 100 ml Ft: Simple syr. 66.7%W/W sucrose in water as per USP 66.7 grams in utop 100 mL of water. Mitte: 20 ml. Procedure: Take the three quarter of vehicle and warm it on hot plate. Then dissolved the calculated amount of sucrose. Finally make up the volume by same vehicle. Uses: used as simple syrups and vehicle. Storage: store in tightly closed container 13Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 EMULSIONS An emulsion consists of two phases, one of which is finely divided and dispersed in the continuous phase. The system is stabilized by the presence of a third substance known as the emulsifying agent. Types of Emulsion 1. Oil-in-water emulsions O/ W: The internal phase/dispersed phase is oil and external/ continuous phase is water. 2. water-in-Oil emulsions W/O: The internal phase/dispersed phase is water and external/ continuous phase is oil. Methods for Preparing Emulsions: One of the following general methods is employed: I. The Dry Gum Method II. The Wet Gum Method The Dry Gum Method/wet gum method In this method, a primary emulsion is made from certain proportion of oil, water and gum. Type of method is depending on the order of addition of gum, water and oil. When a stable primary emulsion has been obtained, it may be freely diluted with more of the continuous phase (water in o/w emulsions). Any salts or flavoring agents are added in dilute solutions just before adjusting the volume. The Quantities for primary emulsions A. Fixed oil, e.g., almond, castor, arachis and cod liver oil. Oil : water : gum 4 : 2 : 1 B. Volatile oil, e.g., turpentine, cinnamon and peppermint oil. Oil : water : gum 2 : 2 : 1 C. Mineral oil (liquid paraffin). Oil : water : gum 3 : 2 : 1 14Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Experiment No 8 AIM: To prepare and submit 40 ml of castor oil. Apparatus: Mortar pestle, beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod Materials: castor oil, gum acacia, water. Fixed Oil Formula: Castor Oil Emulsion Rx Castor oil 16 ml GUM acacia Q.S. Water 80 ml Fiat: emuls Sig. Stat Uses: Castor oil is administered orally as a purgative. Castor oil is a fixed oil. Therefore, the primary emulsion Formula used is: Oil: water: gum 4: 2 :1 Either the dry gum method or the wet gum method can be used, but the former is more suitable. Method of preparation 1. Select a sample-sized mortar and a suitable pestle. 2. Place in the mortar 2 g. acacia (very finely pulverized). 3. Measure 8 ml of oil in a dry measure and pour on the gum allowing some time for the measure to drain. 4. Triturate the oil and gum together for a few seconds. 5. Measure exactly 4 ml of water in another measure. 6. Begin to triturate the oil and, gum again using whipping motion, but not a grinding action. While triturating, add water all at once. 15Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 7. As the water reaches the oil-gum mixture, increase the rate of trituration, taking care to maintain the whipping motion and work in one direction only. 8. Continue trituration till the primary emulsion is formed. This is when the mixture becomes white in colour and cracking sound is heard. 9. Continue to triturate for a little longer before attempting to dilute. 10. Measure small amount of water and add them drop wise, with continuous trituration, to the primary emulsion and then dilute with remaining amount of water and transfer to a measure. 11. Rinse the mortar with more water and adjust the volume. Castor oil emulsion USP (40 ml) Formula: Castor oil : 6.4 ml gum acacia : 1.6 g Water : 28.8 ml Uses: used as purgative Direction for Use: immediately Dose : swallow in one time Secondary Label: shake well before use Storage : Store in tight closed Batch No: Container. Date of Manufacturing: Date of Expiry: Manufactured By: 16Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Suspension Pharmaceutical suspension is a biphasic system composed of finally divided insoluble solid material suspended in liquid medium. The average size of suspended particles ranges from 0.5 µm to 5 µm in most of the pharmaceutical suspensions. Suspensions essentially facilitate the administration of insoluble and often distasteful substances in a form which is pleasant in taste. Properties of good suspensions 1. Upon shaking the particles should be in suspension for a long time enough for the removal of the correct dose. 2. The sediment produced on standing should be easily redispersed. 3. It is easily removed from the container. 4. They should not cake on settling. 5. Their taste should be acceptable to the patient. Factors affecting the settling in Suspension While it is seldom possible to prevent settling completely over a prolonged period of time, it is necessary to consider the factors which influence the velocity of sedimentation. The velocity of sedimentation is expressed by stokes law V = 2r2 (Ps - Po) g 9η Where V : The terminal velocity in cm/sec. r :The radius of the particles in cm . Ps: The density of the dispersed phase. PO: The density of the dispersion medium g : The acceleration due to gravity η : viscosity of !he dispersion medium in poise 17Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Sedimentation volume: Sedimentation volume is the most important parameter in the evaluation of suspension stability. Sedimentation volume F is the ratio of ultimate height of the sediment (Hu, height after sedimentation) to the initial height (Ho) of the total suspension. Sedimentation volume or rate (F) = ultimate height of sediment (Hu) Initial height of suspension (Ho) Sedimentation volume can be plotted against time abscissa and the resultant curve indicates the sedimentation pattern at storage. 18Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Experiment No 9 AIM: To prepare and submit 50 ml barium sulfate suspension. Apparatus: Mortar pestle, beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod. Materials/formula Barium sulfate Suspension Rx Barium sulfate 350.0 g Methyl cellulose (2%) 20.0 g Tween 80, (1%) solution 60.0ml Flavor 5.0 ml Saccharin sodium 0.5 g Sorbitol solution (70%) Purified water to 150.0 ml 1000.0 ml Fiat (let it be made): Draught (large amount swallow in one time) Mitte (send): 50 ml Sig: Stat. (immediately) Procedure: 1. Prepare the methyl cellulose solution by adding small amount of normal water subsequently. 2. Wet the barium sulfate using Tween 80. 3. Add methyl cellulose solution in subsequent amount and triturate well. 4. Dissolve the flavor and saccharin in sorbitol solution and pour into the suspension. 5. Finally add purified water and complete to volume. Uses: It is used as media, during X-ray examination. Dose: whole amount in one time. Storage: store in tight closed container. Secondary label (auxiliary): shake well before use 19Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 20Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Experiment 10 AIM: To prepare and submit 30 ml of antacid Suspension. Apparatus: Mortar pestle, beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod Materials/ formula Rx Magnesium sulphate 5.0 g. Light magnesium carbonate 1.0 g. Peppermint water to 15.0 ml. Fiat: mist. mitte x doses Sig.: 30 ml. o.m. (omn man) (every morning) Procedure: (1) Finally powder magnesium sulphate then mix well with light magnesium carbonate. (2) Measure about three-quarter of the peppermint water, pour a portion of it into the mortar containing the powder and triturate to form a smooth cream; then gradually add the remainder of the vehicle measured out. (3) Examine the contents of the mortar and if particles of foreign matter are visible, spread a piece of muslin over the mouth of the measure, and pour the content, of the mortar through it. (4) Rinse the mortar with a little of the vehicle, and then pass the liquid through the muslin. (3) Finally make up the volume Uses: Laxative and antacid in case of liver cirrhosis. Dose: 30 ml. Storage: store in well closed container Secondary (auxiliary) label: shake well before use. 21Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 22Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Experiment No: 11 Determination of Sedimentation rate AIM: To prepare and determine the of sedimentation rate of magnesium hydroxide suspension and effect of electrolyte on degree of flocculation. Apparatus: Mortar pestle, beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod Materials: magnesium carbonate, sodium hydroxide, sodium chloride, sodium carbonate, sodium sulfate, calcium carbonate, distilled water. Procedure: (1) Take five measuring cylinders (50 ml.), transfer 1 g, magnesium carbonate to each one. (2) Add 45 ml. of each of the following electrolytes H2O, N/10 NaCI, N/10Na2CO3 , N/10 Na2SO4, and N/10 Ca2CO3 (3) To each cylinder add 5 ml. N/10 NaOH and mix well. (4) Leave without disturbance and observe the sedimentation of the particles. (5) Measure the total height (initial height Ho) of each mixture in cm, and Then take the 3-4 reading after 5 min interval that is (Hu, ultimate height). (6) Plot the ratio of sedimentation (F) on Y-axis vs. time at X axis. (7) Calculate the velocity (sedimentation rate) by finding the slope x Molecular weight of following compounds Sodium hydroxide (NaOH) = 39.99 g/mole Sodium Chloride (NaCI) = 58.44 g/mole 23Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Sodium sulfate (Na2SO4) = 142.04g/mole Sodium carbonate (Na2CO3)= 105.9 g/mole Calcium carbonate (CaCO3)= 100.08 g/mole 24Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 LOTIONS Lotions are dilute aqueous solutions or suspensions meant for external application to the body. They may be applied to the skin, hair or eyes. They are applied without friction. They may contain: Humectants ; to retain moisture on the skin after application Alcohol ; which evaporates quickly causes a cooling effect and leaving the skin dry. Experiment No 12 AIM: To prepare and submit 10 ml of calamine lotion Apparatus: Mortar pestle, beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod Materials/formula: Rx Calamine 8 g. Zinc oxide 8 g. Glycerin 6 ml. Lime water to 100 ml. Fiat: lotion (to make lotions) Mitte: 10 ml Sig. M.D.U. (More Dicto Utendus) ( to be used as directed) Procedure: I. Mix calamine and zinc oxide together in a mortar till a homogenous powder is obtained. 2. Pour glycerin and triturate to form ahomogeneous paste. 3. Add a small portion of lime water and continue trituration till a very smooth levigate is obtained. 4. Dilute the smooth levigate with small portion of calcium hydroxide solution (lime water), then 25Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 with large portion following by trituration after each addition till attaining the final volume. Uses: Soothing and protective in cases of skin irritation and dermatitis. Lime water: Saturated calcium hydroxide solution (1.5g/L at 25ºC sparsely soluble). 26Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 SEMISOLID DOSAGE FORMS Semisolid dosage forms: These are dermatological products of semisolid consistency and applied to skin for therapeutic or protective action or cosmetic function Types of conventional semisolid dosage forms: 1. Ointments 2. Creams 3. Pastes 4. Gels 5. Poultices 6. Plasters 7. Rigid foam Paste: Pastes are the semi-solid dosage forms that contain one or more drug substances incorporated in a base with large proportions of finely dispersed solids, are intended for external application to skin, but very thick and stiff. Tooth paste: Toothpaste is a paste or gel dentifrice used with a toothbrush as an accessory to clean and maintain the aesthetics and health of teeth. Toothpaste is used to promote oral hygiene: it serves as an abrasive that aids in removing the dental plaque and food from the teeth, assists in suppressing halitosis, and delivers active ingredients such as fluoride or xylitol to help prevent tooth and gum disease (gingivitis). Most of the cleaning is achieved by the mechanical action of the toothbrush, and not by the toothpaste. Salt and Baking soda are among materials that can be substituted for commercial toothpaste. Toothpaste is not intended to be swallowed. Levigation 27Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Levigation is the process of grinding an insoluble substance to a fine powder, while wet. The material is introduced into the mill together with water, in which the powdered substance remains suspended, and flows from the mill as a turbid liquid or thin paste, according to the amount of water employed. 28Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Experiment 13 Aim: To prepare and submit 10 g of zinc oxide paste. Apparatus: Porcelain dish, water bath, Mortar pestle, beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod Materials/formula: Rx Zinc oxide 25 gm Starch 25 gm Vaseline to 100 gm Send 10 gm Method of preparation; 2) Melt the Vaseline on water bath to 70ºC 1) Incorporate Zinc oxide and starch to the melted Vaseline with continuous stirring until cold. Uses: As protective. Packaging and Storage : Fill on Plastic or glass wide mouthed container and collapsible tubes, store at temperature not more than 25 °C. Label : For external use only 29Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 OINTMENTS: Ointments are semisolid greasy preparations for application to the skin, rectum, nasal mucosal. The base is usually anhydrous and contain the medicament in solution or suspension. Water No: The water number is the largest amount of water in gm that Gm of an ointment base or fat will hold at normal temperature( 20°). Most oleaginous bases can become absorption bases by the addition of an ingredient or ingredients that increase the water number of the oleaginous base. Oleaginous Ointment Bases: Experiment 14 Aim: To prepare and submit 10 g of Zinc ointment. Apparatus: Porcelain dish, water bath, Mortar pestle, beaker (250 ml), measuring cylinder (10 ml. 50 ml), Spatula and glass rod Materials/formula: Rx Methyl Salicylate 10ml Menthol 0.22g White Soft Paraffin qs100g Method of Preparation: 1) Accurately measure 10 ml of Methyl Salicylate , 0.22g of Menthol and 90 g of White Soft Paraffin . 2) Then melt white soft paraffin over a water bath , and remove to cool to 25°C. 30Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 3) Dissolve menthol in Methyl Salicylate and mix well with the melted white soft paraffin , let it be cooled , mix well in the same direction to become homogenous mixture . 4) Then pass this preparation in the triple Roller mill , two times or more till you get a homogenous ointment . Uses : Is used in Musculoskeletal , joint & soft – tissue disorders &for minor peripheral vascular disorders such as chilblains . It can be used ads inhalation for symptomatic relief of upper respiratory – tract disorders . 31Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Doses : Apply to Affected area three times daily . Packaging and Storage : Fill on Plastic Wide mouthed container or ointment tubes, and store at temperature not more than 25 °C . Stability : It is stable for three month Label : For External use only . Protect from light . Experiment No. 15 Object Prepare and supply 50 gm Tooth Powder. Formula Precipitated calcium carbonate 92.0 gm Hard soap, powdered 50.0 gm Saccharin 2.0 gm Peppermint oil 4.0 ml Cinnamon oil 2.0 ml Procedure Pass the solid substances through a fine sieve and mix them in the ascending order of their weights. To the mixed powders add the flavouring agents and mix thoroughly. Again pass through the sieve to remove lumps, if formed. Storage Store in a well-closed container. Uses This preparation is used as a tooth powder. Explanation 1. Precipitated calcium carbonate is used as abrasive. Abrasives are the substances which are used to remove debris and residual stains from the teeth and for polishing the tooth surface. 2. Powdered hard soap is used to enhance the action of abrasives by wetting the teeth, the food particles, if any, and to emulsify the mucous. 3. Saccharin is used as a sweetening agent. 4. Peppermint oil and cinnamon oil are used as flavouring agents. 32Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Experiment No. 16 Object Prepare granules for 100 tablets of Calcium Lactate I.P. 1966 and compress 30 tablets each contains.100 mg of Calcium Lactate. Procedure Mix the weighed amount of calcium lactate with half the calculated quantity of starch. To this add sufficient quantity of 10% starch mucilage which will act as granulating agent and binding agent. Mix thoroughly so as to get wet coherent mass. Pass this wet mass through a sieve No. 10 to prepare the granules. Dry the granules in an oven at a temperature not exceeding 60°C. Pass the dried granules again through sieve No. 10 superimposed on sieve No. 20 to get the granules of proper size. Mix the granules so obtained with the second portion of disintegrating agent, lubricants and flavouring agents. The blended granules are thus ready for compression. Storage It should be stored in a well-closed container. Dose 1 to 5 gm. Uses It is used in the treatment of calcium deficiency. Explanation 1. As the quantity of calcium lactate is sufficient to be compressed therefore there is no need to add any diluent. 2. Calcium lactate is insoluble in water therefore a disintegrating agent is required to be added. 3. A granulating agent is used to prepare the granules. For this purpose 10% starch mucilage is used which acts as granulating agent and binding agent. 4. Disintegrating agent i.e. starch 5% is added in two stages one before granulation and the other after the granulation i.e. before compression. The second portion added helps in breaking the tablet in smaller particles whereas the first portion of disintegrating agent added before granulation helps in breaking the granules into still smaller particles. 5. Two sieves i.e. sieve No. 10 superimposed on sieve No. 20 are used to get the granules of proper size having sufficient amount of fine powder in it for easy and uniform compression of granules into tablets. The granules passed through sieve No. 10 but retained over sieve No. 20 are used for compression. The excess of fine powder which passes through sieve No. 20 is rejected. 33Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 Experiment No. 17 Object Prepare and supply 5 ampoules of 5 ml each of Sodium Chloride Injection I.P. 1966. Synonym Normal saline solution for injection. IP. Formula Sodium chloride 9gm Water for injection, sufficient to produce 1000 ml Procedure Dissolve sodium chloride in sufficient amount of water for injection to produce the required volume. Filter the solution, if necessary. Distribute this solution in required number of thoroughly cleaned dried ampoules, seal them and sterilize in an autoclave as early as possible. Storage This injection on storage may lead to separation of small particles from the glass container. A Solution containing such particles may not be used. Uses It is used as an electrolyte replenisher. It is given intravenously along with dextrose injection to those who are unable to take fluids by mouth. Sodium chloride injection is often given parenterally in the treatment of poisoning by meroura salts, phenol and other substances eliminated by the kidneys, except where there is pulmonary oedema. Explanation 1. 0.9% w/v solution of sodium chloride is known as normal saline solution. 2. Sodium chloride solution can be sterilised by autoclaving or by filtration through bacteria-proof filters 3. Sodium chloride injections have a tendency that on keeping, separation of small particles from glass containers may take place. Solutions containing such particles must not be used. 34Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312 35Page DEPARTMENT OF PHARMACEUTICS LABORATORY MANUAL PHT 312