7. To provide for the optimum drug action through inhalation therapy e.g. inhalation aerosols and inhalants. PHARMACEUTICS-1 synus SAINNVYD (ssapmod yoo) 41N39S3A83443 SOSUNUTQ 2 SH30MOd SUOHEYNSU] SSINNVYD NIJ syepmod Bunsng nae) WNY31X3 TWNYSLNI a enerreeres | sdoup jesen - | sdoup eA, ‘suono) aA sheds S@yseM YINOYy sdoig ‘squred yeouuy snjour, sojbiep ‘sui, suono7 Silld oon sdrukg squewiury SuapMog TWNYALNI “TWNY: a sans SOUESseg SWE suoisuedsng _ Soa ‘Seu0ysoddns SIUBWUILIO suorsinw3 L—____ | WHO WNUYALNI WNY3LXS | OISWHdIa SISVHAONOW wine a9vSsod LINN -___ Ls LC SWHOS 39vSoa sSWuOs soy anos-In3as 39vsoa ainon 39vS0q anos L 1 : swuo4 20vSO0 J Ch-| INTRODUCTION TO DIFFERENT DOSAGE FORMS 8. To provide the maximum drug action from topical administra-iL & WwW a | y & 8 2 42 E L Geese, & 2 ore 29s ww 2 o aia zo EF Sa cs z 2 Ch-| INTRODUCTION TO DIFFERENT DOSAGE FORMS 3 8, To provide the maximum drug action from topical administra- tion sites ¢.g. creams, ointments, ophthalmic preparations and E.N.T. (Ear, Nose and Throat) preparations. 9. To Provide ‘sustaincd released action through controlled released mechanism, ¢.8. Sustained released tablets, capsules and suspen- sions. 10. To provide liquid dosage form of the drugs soluble in a suitable vehicle e.g. solutions. ly To provide liquid preparation of the drugs which are insoluble or unstable in different vehicles e.g. suspensions. \2. To provide the drugs within body tissues e.g. injections. ™ CLASSIFICATION OF DOSAGE FORMS & Dosage forms may be classified on the basis of physical form of the final product which are as under: 1. Solid dosage form 2. Liquid dosage form 3. Semi-solid dosage form ® SOLID DOSAGE FORMS & \ The solid dosage forms are available mostly in unit dosage forms (consisting of doses which are taken by numbers) such as tablets, capsules, pills, cachets or powders. When drugs are to be administered orally in dry state, tablets and capsules are the most convenient dbsage form. They are effective and patients have no problem in their handling, identification and administration, Some solids are packed and supplied in bulk. The bulk forms meant for internal use are supplied either as granules or fine powder. The bulk powders meant for external use are dusting powders, insufflations, snuffs and tooth powders. , Powders are the solid dosage form of medicament, which are meant for internal or external use. They are available in crystalline or amor- phous form. The powders are generally used in the following forms: 1. Bulk powder for internal use e.g. fine powders or granules 2. Bulk powder for external use e.g. snuffs, dusting powders tooth powders and insufflation. 3. Simple and compound powders for internal use. 4. Powders in the form of compressed tablets and tablet triturates. 5. Powders enclosed in cachets and capsules. A eta DAS At pen.phous form. The powders are generally used in the following forms: 1, Bulk powder for internal use e.g. fine powders or granules 2. Bulk powder for external use e.g. snuffs, dusting powders tooth powders and insufflation. . Simple and compound powders for internal use. . Powders in the form of compressed tablets and tablet triturates. ww . Powders enclosed in cachets and capsules. 4 PHARMACEUTICS-1 Dusting Powders & These are meant for external application to the skin and are generally applied in a very fine state of subdivision to avoid local irritation, Hence, dusting powders should be passed through a 80 sieve to enhance their effectiveness. Dusting powders are of two types: (i) Medical (ii) Surgical Medical dusting powders are used mainly for superficial skin condi- tions whereas surgical dusting powders are used in body cavities and also on major wounds as a result of burns and umbilical cords of infants, Surgical dusting powders must be sterilised before their use, whereas inedical dusting powders must be free from dangerous pathogenic micro- organi: Dusting powders are generally prepared by mixing two or more ingredients one of which must be cither starch, kaolin or talc as one of the ingredients of the formulation. Talc and kaolin are more commonly used because these are chemically inert. However, since such ingredi- ents are readily contaminated with pathogenic bacteria, these must be sterilised dry heat method (160° for 2 hours) before their use.. The dusting powders are mainly used for their antiseptic, astringent, absorbent, antiperspirant and antipruritic action. Insufflations These are medicated dusting powders meant for introduction into the bedy cavities such as nose, throat, ears and vagina with the help of an avparatus known as “Insufflator”. It sprays the powder into a stream of finely divided particles all over the site of application. The following difficulties are however generally faced while using the insufflators: (i) It is difficult to obtain a measured quantity of the drug as a uniform dose. (ii) It gets blocked when it is slightly wet or the powder used is wet. Insufflations should be in finely divided powders so that a stream of fine particles of medicaments gets applied to the site of application. Nowadays the insufflations are available in the form of pressure aerosols. These are used for the administration of potent drugs. This method has the advantage of excellent control of dose through metered valves. Moreover, it also protects the product from external environment.Moreover, it also protects the product from external environment. Ch-1 INTRODUCTION TO DIFFERENT DOSAGE FORMS 5 The insufflations are used to produce a local effect, as in the treat- ment of car, nose and throat infection with antibiotics or to produce a systemic effect from a drug that is destroyed in the gut. Snuffs | These are finely divided solid dosage forms of medicament which are inhaled into nostrils for its antiseptic, bronchiodilator and decongestion action. Dentifrices (Tooth powders) © (These are applied with the help of a tooth brush for cleaning the surface of the teeth. They contain a suitable detergent or soap, some abrasive substance and a suitable flavour. The abrasive agents such as calcium sulphate, magnesium carbonate, sodium carbonate and sodium chloride are used in fine powder. A strong abrasive substance should however not to be used as it may damage the tooth structure) The commonly used formula of dentifrice is as follows. DENTIFRICE (NF XI) Hard soap, in fine powder 50 g Precipitated calcium carbonate 935 g Saccharin sodium 22 Peppermint oil 4ml Cinnamon oil 2m! Methyl! salicylate ¢ 8 ml Triturate the saccharin sodium, the oils and methyl salicylate with about one half of the precipitated calcium carbonate and mix the soap with the remaining portion of the precipitated calcium carbonate. Mix the two powders thoroughly and then pass it through a fine sieve. Granules The bitter, nauseous and unpleasant powders cannot be given in tablet form or in a capsule because a large number of them are required to be taken as a single dose. These powders are not given in liquid form because of stability problem. Such medicaments are given in the form of granule: The solid medicaments are mixed with sweetening, flavouring and colouring agent. A suitable granulating agent is added to moisten the powder so as to form a coherent mass, The coherent mass is passed through*sieve number 10 to make granules. Dry the granules in an hot air oven at a temperature no exceeding 60°C. The dry granules are Passed through sieve number 20. The dry granules are supplied in single-dose sachets which are dissolved in water before taking. Now-a-days, various antibiotics like erythromycin, phenoxymethyl penicillin etc., whi PHARMACEUTICS-1 ampicillin, ich are unstable in solution are pre- . mived with suspending. itair oven at a temperature no exceeding 60°C. The dry granules are passed through sieve number 20. The dry granules are supplied in Single-dose sachets which are dissolved in water before taking. 6 PHARMACEUTICS-1 Now-a-days, various antibiotics like erythromycin, ampicillin, phenoxymethy! penicillin etc., which are unstable in solution are pre- pared in the dry granular form in which drug is mixed with suspending, sweetening, flavouring, colouring and granulating agents. The granules are prepared and packed in a special type of bottles with a specific direction on its label for the patient to add specific amount of freshly boiled and cooled water to dissolve it or shake well to form a homog- enous solution. The label should also state the time limit within which the reconstituted preparation should be consumed. Effervescent Granules ® The effervescent granules are the form of medicament, meant for internal use. They contain a medica- ment mixed with citric acid, tartaric acid and sodium bicarbonate. Sometimes saccharin or sucrose may be added as a sweetening agent. Before administration, the desired quantity is dissolved in water, the acid and bicarbonate react together producing effervescence. The carbonated water produced from the release ‘of carbon dioxide serves to mask the bitter and saline taste of drugs. Moreover, carbon dioxide stimulates the flow of gastric juice and helps in the absorption of medicament. Methods of preparation There ar> two methods of preparation of effervescent granules. 1. Heat method 2. Wet method Heat method A large porcelain or stainless steel evaporating dish is placed over the boiling water bath. The dish must be sufficiently hot before transferring the powder into it, to ensure rapid liberation of the water of the crystallisation from the citric acid. If heating of the dish is delayed, the powder which is added to it, will heat up slowly and the liberated water of crystallisation will go on evaporating simultaneously. ‘As a result, sufficient water will not be available to make a coherent mass specially prepared solid dosage The water needed for granulation is provided from two source (i) From water of crystallisation of citric acid. The citri contains one molecule of water of crystallisation which is liberated during heating. Gi) The water produced from the reactions of citric acid and tartaric acid with sodium bicarbonate. 3NaHCO; + CgHx07.H»0 4, C6HsNa307 + 3CO2 + 3H20 Sodium bicarbonate Citic acid Sodium citrate Ch-1 INTRODUCTION TO DIFFERENT DOSAGE FORMS 7 2NaHCO3 + C4H¢Os 4+ CyHyNayO, + 2CO; + 2H,0 Tartaric acid Sodium tartarate3NaHCO; + C¢H,07.H,0 44 (C6HsNa3O7 + 3CO + 3H20 Sodium bicarbonate Citric acid Sodium citrate Ch-1_ INTRODUCTION TO DIFFERENT DOSAGE FORMS 7 2NaHCO3 + CyHe, —4+ CyHyNajOg + 2CO2 + 2H,0 Tartaric acid Sodium tartarate Generally, heating stage takes 1 to 5 minutes. The damp mass is then passed through a sieve to prepare the granules of suitable size, dried in an oven at a temperature not exceeding 60°C and then packed in an air tight container. Wet method In this method, the mixed ingredients are moistened with a non-aqueous liquid (e.g, Alcohol) to prepare a coherent mass which is then passed through a No. 8 sieve and dried in an oven at a temperature not exceeding 60°C. The dried granules are again passed through the sieve to break the lumps which may be formed during drying. The dried granules are packed in air tight containers. Tablets © These are solid dosage forms of medicament or medicaments which are prepared by moulding or by compression. Certain excipients are also added to the medicaments in the formulation of tablets. The compressed tablets are prepared in bulk by the large-scale production methods. (Detail is given in the chapter, “Processing of Tablets") Capsules The capsules are solid unit dosage form in which one or more medicaments and inert substances are enclosed within a small shell, generally prepared from a suitable form of gelatin. Depending on their formulation, the gelatin capsule shell may be hard or soft. (Detail is given in the chapter, “Processing of Capsules") Pills Pills are small, rounded solid dosage forms containing medicament and intended to be administered orally. The medicaments are mixed with excipients to form a firm plastic mass. The mass is rolled to uniform pill pipe. which is cut into a number of pills. These are rounded to form pills of uniform size and shape. Pills are spherical in shape and are produced by rolling them under wooden pill rounder. The pills are sometimes coated with varnish, silver leaf, gold leaf to improve the finish, mask the unpleasant tastes and increase stability. In olden days pills were preferred because of their spherical shape which can be easily swallowed. But now the pills are outdated prepara- tions because of a number of disadvantages such as: 1. The disintegration time of pills is uncertain. The freshly _pre- pared pills disintegrate readily as compared to the old dried pills. PHARMACEUTICS-1 The dried pills are less soluble and sometimes pass through G.LT. without 4;sn OlGen Gays PIS Were PICIcrieG eee ee which can be easily swallowed. But now the pills are outdated prepara- lions because of a number of disadvantages such as: 1. The disintegration time of pills is uncertain. The freshly pre- pared pills disintegrate readily as compared to the old dried pills. PHARMACEUTICS-1 The dried pills are less soluble and sometimes pass through G.LT. without disintegration. 2. It is difficult to prepare pills of a uniform size. 3. It is not possible to prepare pills of a uniform weight. © LIQUID DOSAGE FORMS @ Liquid stage forms are meant for internal, parenteral or external use. They are available in monophasic or biphasic forms. MONOPHASIC LIQUID DOSAGE FORMS Monophasic liquid dosage forms are represented by true or colloidal solution. The component of the solution which is present in a large quantity is known as “solvent”, whereas the component present in a small quantity is termed as “solute”. Water is mainly used as solvent for majority of monophasic liquid dosage forms. A solution is homogenous because the solute is in an ionic or molecular form of subdivision. In case of colloidal solutions, the solute are present as aggregates although they cannot be seen by the naked eye or under ordinary microscope. Monophasic liquid dosage forms are available as: 1. Liquids for internal use e.g. syrups, elixirs, linctus, drops and draughts. 2. Liquids for external use, which are of two types: (a) Liquids to be applied to the skin e.g. liniments and lotions etc. (b) Liquids meant for body cavities ¢.g. gargles, throat paints, mouth washes, eye drops, eye lotions, ear drops, nasal drops, sprays and inhalations. Syrups Simple syrup is a saturated solution of sucrose in purified water. The concentration of sugar is 66% wAv, The syrups are sweet ‘ous preparations. The syrups containing medicinal substances are called “Medicated syrups” and those containing aromatic or flavoured sub- stances are known as “Flavoured syrups”. Syrups are very commonly used for the following reasons: 1. Syrups retards oxidation because it is partly hydrolysed into reducing sugars, such as, lavulose and dextrose. 2. It prevents decomposition of many vegetable substances. Syrups have high osmotic pressure which prevents growth of bacteria, fungi and moulds which are the chief causes of decomposition in solutions of vegetable matter. Ch-1]_ INTRODUCTION TO DIFFERENT DOSAGE FORMS. 9reducing sugars, such as, lavulose and dextrose. 2. It prevents decomposition of many vegetable substances. Syrups have high osmotic pressure which prevents growth of bacteria, fungi and moulds which are the chief causes of decomposition in solutions of vegetable matter. Ch-]_ INTRODUCTION TO DIFFERENT DOSAGE FORMS 9 3. They are palatable. Due to the sweetness of sugar it is a valuable vehicle for the administration of nauseous substances. The syrups may be divided into two groups:— (a) Syrups Prepared by simple solution or admixture ¢.g. syrups, syrup ginger, syrup orange and syrup lemon. SYRUP LP, Sucrose 667 g Purified water, sufficient to produce 1000 g Add sucrose to purified water and heat it to dissolve sucrose with occasional stirring. Cool it and add more of purified water to make the required weight. GINGER SYRUP LP. Strong ginger tincture 50 ml Syrup. sufficient to produce 1000 ml Mix. (b) Syrups made by a process of extraction e.g. Tolu syrup. TOLU SYRUP LP. Tolu balsam 12.5 g Sucrose 660.0 g Purified water sufficient to produce 1000.0 g Add boiling purified water to the Tolu balsam contained in a tared vessel, Cover the vessel lightly and boil the contents gently for half an hour, stirring frequently. Add purified water to adjust the specified weight. Cool, filter the solution and add sucrose. Heat on a water-bath to dissolve the sucrose. Finally add sufficient purified water to produce the required volume. Syrups are now used for formulating antibiotics, antihistaminics, sedatives, antitussives, vitamins and bitter or saline drugs. Elixirs are sweet aromatic preparations and are usually coloured. The main ingredients of elixirs are ethyl alcohol (4-40%), water, glycerin or propylene glycol, flavouring agent, syrup and some suitable preserva- tive. The medicated elixirs usually contain some very potent drug. such as, antibiotics, antihistamines or sedatives. The flavouring elixirs are used as flavours and vehicles. The following are examples. of commonly used elixirs: 10 PHARMACEUTICS-1used as flavours and vehicles. The following are examples of commonly used elixirs: 10 PHARMACEUTICS-1 PIPERAZINE CITRATE ELIXIR 1.P. Piperazine citrate 180 g Chloroform spirit 5 ml Glycerin 100 ml Syrup 500 ml Purified water, sufficient to produce 1000 ml Dissolve the piperazine citrate in part of the purified water. Add the orange oil, glycerin, syrup, chloroform spirit and sufficient purified water to produce the required volume. PHENOBARBITONE ELIXIR LP. Phenobarbitone 400 mg Alcohol 90% 40 ml Compound orange spirit 2.5 ml Glycerol 40.0 ml Amaranth solution 1.0 ml Purified water, sufficient to produce 100 ml Dissolve the phenobarbitone in alcohol 90%. Add the compound orange spirit before adding the glycerol and amaranth solution. Add sufficient quantity of water to make the required volume. Linctuses Linctuses are viscous liquid and oral preparations that are generally prescribed for the relief of cough. They contain medicaments which have demulcent, sedative or expectorant action. Linctuses should be taken in small doses, sipped and swallowed slowly without diluting it with water in order to have the maximum and prolonged effect of medicaments. Simple syrup is generally used as a vehicle for most of the linctuses. Tolu syrup is preferred in certain cas: because of its aromatic odour and flavour, Moreover, it is believed to have a mild expectorant action ¢.g. CODEINE LINCTUS B.P.C. Codeine phosphate ag Lemon syrup 200 ml Benzoic acid solution 20 ml Chloroform spirit 20 ml Water 20 ml Compound tartrazine solution 10 ml Syrup to make 1000 ml Weigh codeine phosphate and dissolve it in water, heat gently. if required. Add benzoic acid solution, compound tanrazine solution and chloroform spirit, Add the lemon syrup and adjust the volume by adding more of syrup. ch-1 INTRODUCTION TO DIFFERENT DOSAGE FORMS 11Syrup to make 1000 ml Weigh codeine phosphate and dissolve it in water, heat gently, if required. Add benzoic acid solution, compound tartrazine solution a chloroform spirit. Add the lemon syrup and adjust the volume by adding more of syrup. Chl INTRODUCTION TO DIFFERENT DOSAGE FORMS iP Drops® These are liquid Preparations meant for oral administrations. The oil soluble vitamins, such as, vitamin A and D concentrates in fish-liver oil are presented as drops for administration. Since these preparations contain potent medicaments, the dose must be measured accurately. The following two methods are commonly used for this purpose: (a) Use of a dropper which is accurately graduated in fractions of a millilitre. (b) Use of a ‘Pre-calibrated dropper in which the number of drops equivalent to the prescribed dose of the particular preparation being administered is known. The size of the drops from the medicine dropper depends on factors, such as, surface tension, viscosity, density and temperature of the liquid. Liniments * Liniments are liquid and semi-liquid preparations meant for applica- tion to the skin. Liniments are usually applied to the skin with friction and rubbing of the skin. The liniments may be alcoholic or oily solutions or emulsion. Alcohol helps in the penetration of medicaments into the skin and also increases its counter-irritant or rubefacient action. Arachis oil is used in some liniments which spread more easily on the skin, Soap is also included as ingredients in some of the liniments which helps in easy application of liniment on the skin. Generally, liniments contain medicaments possessing analgesic, rube- facient. soothing and counter-irritant or stimulating properties. A liniment should not be applied to broken skin because it may cause excessive irritation. The following are some of the liniments which ure official in Phar- macopoeia of India. CAMPHOR LINIMENT Camphor 200 g Arachis oil 8U0 g Dissolve the camphor in the arachis oil in a closed vessel. AMMONIATED CAMPHOR LINIMENT Camphor 125 g Eucalyptus oil 5 ml 250 mi Ammonia solution strong Alcohol (90%) sufficient to produce 1000 ml Dissolve the camphor and eucalyptus oil in 600 ml of alcohol 90%. Add the ammonia solution strong gradually with frequent shaking into it. Add sufficient alcohol 90% to produce the required volume. 12 PHARMACEUTICS-1 TURPENTINE | INTMAENTDissolve the camphor and eucalyptus oil in 600 ml of alconon es Add the ammonia solution strong gradually with frequent shaking into it. Add sufficient alcohol 90% to produce the required volume. vi PHARMACEUTICS-1 TURPENTINE LINIMENT Soft soap 90g Camphor 50g Turpentine oil (freshly rectified) 650 ml Purified water, sufficient to produce 1000 ml Mix the soft soap with 100 ml of purified water. Prepare a solution of the camphor in the freshly rectified turpentine oil. Gradually add the camphor solution to the soap mixture with trituration till a thick creamy emulsion is formed. Add sufficient purified water to produce the required volume. Mix it thoroughly. SOAP LINIMENT Soft soap 80g Camphor 40g Lemon grass oil 15 ml Purified water 170 ml Alcohol (90 per cent), sufficient to produce 1000 ml Dissolve the soft soap, camphor, and lemon grass oil in 600 ml of alcohol (90 per cent). Add the purified water and sufficient alcohol (90 per cent) to produce the required volume. Set aside for a week and filter, Lotions Lotions are liquid preparations meant for external application without friction. They are applied direct to the skin with the help of some absorbent material, such as, cotton wool or gauze soaked in it. Lotions may be used for local action as cooling, soothing or protective purposes. They are generally prescribed for antiseptic action. ¢.g. calamine lotion. CALAMINE LOTION LP. Calamine 150 g Zine oxide 50g Bentonite 30g Sodium citrate Seg Liquefied phenol - 5 ml Glycerin 50 ml Rose water, of commerce, sufficient to produce 1000 mil Dissolve sodium citrate in about 700 ml of rose water. Triturate the calamine, zine oxide and bentonite with a solution of the sodium citrate. Add the liquefied phenol and the glycerin. Add rose water in sufficient quantity to produce the required volume. Alcohol is sometimes included in aqueous lotions for its cooling and soothing effect e.g. salicylic acid lotion. In salicylic acid and mercuric ch-1_ INTRODUCTION TO DIFFERENT DOSAGE FORMS 13 chloride lotion acetone is used as a vehicle. The preparation is used for scalp conditions. SATICVIIC ACIN IT ATING 2Dcalamune, zine Oxide and bentonite with a soluuon of the sodium citrate. Add the liquefied phenol and the glycerin. Add rose water in sufficient quantily to produce the required volume. Alcohol is sometimes included in aqueous lotions for its cooling and soothing effect e.g. salicylic acid lotion. In salicylic acid and mercuric h-|_ INTRODUCTION TO DIFFERENT DOSAGE FORMS 13 chloride lotion acetone is used as a vehicle. The preparation is used for scalp conditions. SALICYLIC ACID LOTION B.P. Salicylic acid 2.08 Castor oil 1.0 ml Alcohol (90 per cent) to make 100 mi Dissolve salicylic acid in 3/4" of alcohol 90%. Add castor oil. Add more of alcohol 90% to make final volume. Gargles Gargles are aqueous solutions used to prevent or treat throat infec- tions. They are usually available in concentrated form with direction for dilution with warm water before use. They are brought into intimate contact with the mucous membrane of the throat and are allowed to remain in contact with it for a few seconds, before they are thrown out of the mouth . They are used to relieve soreness in mild throat infection. Phenol or thymol is generally present in small concentration for its antibacterial activity. Potassium chlorate is also included in gargles for its weak astringent effect to tone up a relaxed throat. It also stimulates secretion of saliva which relieves dryness e.g. phenol gargles, potassium chloride and phenol gargles. POTASSIUM CHLORATE AND PHENOL GARGLES B.P.C. Potassium chlorate 30.0 g Patent blue V 0.009 g Liquefied phenol 15.0 ml Water sufficient to make 1000 ml Dissolve the potassium chlorate in warm water, Cool and add liquefied phenol. Add the dye solution, filter and make up the volume. Mouth Washes These are aqueous solutions with a pleasant taste and odour used to make clean and deodorise the buccal cavity. Generally, they contain antibacterial agents, alcohol, glycerin, sweetening agents, flavouring agents and colouring agents. SODIUM CHLORIDE MOUTH-WASH, COMPOUND B.P.C. Sodium chloride IS g Sodium bicarbonate 10 g Peppermint water to produce 1000 ml 14 PHARMACEUTICS+1 |Sodium bicarbonate 10g Peppermint water to produce 1000 ml 14 PHARMACEUTICS-| ZINC SULPHATE AND ZINC CHLORIDE MOUTH-WASH B.P.C. Zinc sulphate 20 g Zinc chloride 10g Dilute hydrochloric acid 10 ml Compound tartrazine solution 10 ml Chloroform water to produce 1000 ml Dissolve the zinc sulphate and zinc chloride in water. Add dilute hydrochloric acid to make a clear solution. Add compound tartrazine solution. Add chloroform water to make the required volume. Throat Paints & Throat paints are viscous liqu throat infections. Glycerin is comi viscous, it adheres to mucous membrane for Possesses a sweet taste. IODINE PAINT COMPOUND (MANDL'S PAINT) B.P.C. id preparations used for mouth and monly used as a base because, being a long period and it Potassium iodide 25.0 Todine 12.5 g Alcohol (90%) 40.0 ml Water 25.0 ml Peppermint oil 4.0 ml 1000.0 ml Glycerin to produce Dissolve the potassium iodide in water. Add the iodine and stir until completely dissolved. Dissolve peppermint oil in alcohol 90% in a small container and then transfer it into the iodine solution. Mix well. Add glycerin and mix thoroughly. Add more of glycerin to make the required volume. The preparation is to be stored in a cool place since iodine is volatile in nature. Sprays © Sprays are preparations of drugs in media which may be aqueous, alcoholic or glycerin. They are applied to the mucous membrane of nose or throat with an atomiser. The throat-sprays must be sprayed from a special type of atomiser known as ‘nebuliser’, which removes large droplets by a baffling system. Only fine droplets are required so that they may reach the lungs. ADRENALINE AND ATROPINE SPRAY COMPOUND B.P.C. Adrenaline acid tartrate 8.0 2 Atropine methonitrate 10g Papaverine hydrochloride 8.0 2 Sodium metabisulphite 10g h-|_ INTRODUCTION TO DIFFERENT DOSAGE PORMSiodine is volatile in nature. Sprays © Sprays ate preparations of drugs in media which may be aqueous, alcoholic or glycerin. They are applied to the mucous membrane of nose or throat with an atomiser. The throat-sprays must be sprayed from a special type of atomiser known as snebuliser’, which removes large droplets by a baffling system. Only fine droplets are required so that they may reach the lungs. ADRENALINE AND ATROPINE SPRAY COMPOUND B.P.C: Adrenaline acid tartrate 80g Atropine methonitrate 10g Papaverine hydrochloride 8.0 g Sodium metabisulphite 10g Ch-1_ INTRODUCTION TO DIFFERENT DOSAGE FORMS 15 Chlorobutol 5.08 Propylene glycol 50.0 ml Purified water, freshly boiled and cooled to make 1000 ml Prepare freshly boiled and cooled purified water. Dissolve separatrely the adrenaline acid tartrate, atropine methonitrate and sodium metabisulphite in this water. Mix the three solutions. Dissolve the paverine hydrochloride in the mixture. Prepare the solution of chlorobutol in propylene glycol and add the solution to the above mixture. Filter if necessary and adjust to volume through the filter. Inhalations ™ These are liquid preparations containing volatile substances and are used to relieve congestion and inflammation of the respiratory tract. The inhalations containing the volatile substances which are volatile at room temperature may be placed on an absorbent pad or handkerchief to inhale therefrom. In other cases inhalations are added to hot, but not boiling water (about 65°C) and vapours are inhaled for about 10 minutes. BENZOIN INHALATION B.P.C. Benzoin crushed 100 g Prepared storax 50g Alcohol (95 per cent) to produce 1000 ml It is prepared by macerating the benzoin and the prepared storax with alcohol 95% for 24 hours. Filter and pass sufficient of the alcohol through the filter to produce the required volume. MENTHOL AND EUCALYPTUS INHALATION B.P.C, Light magnesium carbonate 70 2 Menthol 20g Eucalyptus oil 100 ml Water to produce 1000 ml Dissolve the menthol in eucalyptus oil and add light magnesium carbonate and sufficient water to produce the required volume. Nasal Drops These are solutions of drugs that are instilled into the nose with a dropper. These are usually aqueous and not oily drops. since the latter inhibit the movement of cilia in the nasal mucosa and if used for long periods, may reach the lungs and cause lipoid Pneumonia. Nasal drops should be isotonic having neutral pH and viscosity similar to nasal secretions by using methyl cellulose. 16 PHARMACEUTICS.1Ne ee These are solutions of drugs that are instilled into the nose with a dropper. These are usually aqueous and not oily drops. since the latter inhibit the movement of cilia in the nasal mucosa and if used for long periods, may reach the lungs and cause lipoid Pneumonia. Nasal drops should be isotonic having neutral pH and viscosity similar to nasal secretions by using methyl cellulose. 16 PHARMACEUTICS. | EPHEDRINE NASAL DROPS B.P.C. | Ephedrine hydrochloride 05 g Chlorobutol 05 g Sodium chloride 0.5 g { Water to produce 1000 ml Dissolve the ephedrine hydrochloride, chlorobutel and sodium chlo- ride in water. Cool, filter if necessary. Add more water on filter to make the required volume. Eye Drops ® These are sterile solutions or suspensions of drugs that are instilled (put in by drops) into the eye with a dropper. The eye drops are usually made in aqueous vehicle. It should be sterile, isotonic with lachrymal secretions, buffered and free from foreign particles to avoid irritation to the eye. A suitable preservative like phenyl mercuric nitrate (0.002%), benzalkonium chloride (0.01%) and chlorhexidine acetate (0.01%) may be used to prevent bacterial or fungal growth. Eye drops usually contain substances having antiseptic, anti-inflammatory, anaesthetic and miotic properties. The eye drops are generally prepared by dissolving the medicament in the aqueous vehicle containing one of the prescribed antimicrobial substances and any other preservative specified in the individual mono- graph. The solution is clarified by filtration and transferred to the final containers, which are then closed to exclude micro-organisms. The steri- lisation is done by autoclaving or by heating with bactericide at 98°C to 100°C for 30 minutes or by filtration through bacteria proof filter. The eye drops should be packed in neutral glass containers or in a suitable plastic container. The glass droppers are made of neutral glass. The teats are made of rubber which are compatible with the antimicro- bial substance to be used in the formulation. The following precautions are required to be observed while using eye drops: . If the dropper is separate, always hold it with its tip down. Never touch the dropper surface. . Never rinse the dropper. Never use eye drops that have changed colour. When the dropper is at the top of the bottle, avoid contami- nating the cap when removed. 6. After instillation of drops. do not close eyes tightly or blink more often than usual as this may remove the medicine from the place where it is needed. whene Ch-I_ INTRODUCTION TO DIFFERENT DOSAGE FORMS 7 Eye Lotions & These are the aqueous solutions used for washing the eyes. The eye lotions are supplied in concentrated form and are required to be diluted with warm water immediately before use. Eye lotions should be isotonic and free from foreign particles to avoid irritation to the eye. They are required to be prepared afresh and should not be stored for more than two days as the lotion may get contaminated with micro-4. Never use eye drops that have changed colour. 5. When the dropper is at the top of the bottle, avoid contami- nating the cap when removed. 6. After instillation of drops, do not close eyes tightly or blink more often than usual as this may remove the mediciné from the place where it is needed. Ch-l_ INTRODUCTION TO DIFFERENT DOSAGE FORMS 7 Eye Lotions & These are the aqueous solutions used for washing the cyes. The eye lotions are supplied in concentrated form and are: required to be diluted with warm water immediately before use, Eye lotions should be isotonic and free from foreign particles to avoid irritation to the eye. They are required to be prepared afresh and should not be stored for more than two days as the lotion may get contaminated with micro- organisms. Two examples of eye lotion are given below: SODIUM CHLORIDE EYE LOTION Sodium chloride og Purified water to produce + 1000 ml SODIUM BICARBONATE EYE LOTION Sodium bicarbonate 35¢g Purified water to produce 1000 mi Ear Drops & These are solutions of drugs that are instilled into the ear with a dropper. These are generally used for cleaning the ear, softening the wax and for treating the mild infections. The solution is generally prepared in water, glycerin, propylene glycol or dilute alcohol. How- ever, vehicles like glycerin and propylene glycol are preferred. SODIUM BICARBONATE EAR-DROPS .B.P.C. Sodium bicarbonate Sg Glycerin 30 mi Purified water to produce 100 ml Dissolve sodium bicarbonate in water. Add the glycerin and suffi- cient of the water to produce the required volume, and mix. The ear-drops should have been prepared recently. PHENOL EAR-DROPS B.P.C. Phenol glycerin 40 ml Glycerin to produce 100 ml BIPHASIC LIQUID DOSAGE FORMS The liquids which consist of two phases are known as biphasic liquids ¢.g. emulsions and suspensions. In general both the phases are liquid, while in suspensions the finely divided solids are dispersed in a liquid which acts as a continuous phase. ld PHARMACEUTICS.] Emulsions An emulsion is a biphasic liquid preparation containing two immiscj- ble liquids, one of which ute globules into the other, The liquid which is converte ; ’ persed phase’ and the liquid in which the globules are dispersed is called the ‘continuous phase’. Normally, two immiscible liquids cannot be dispersed for a long period. So, an emulsifying agent is added to the system. It forms a film around the globules in order to scatter them “Et DA eee nee Se enaieelThe liquids which consist of two phases are known as biphasic liquids e.g. emulsions and suspensions. In general both the phases are liquid, while in suspensions the finely divided solids are dispersed in a liquid which acts as a continuous phase. Is PHARMACEUTICS.| Emulsions An emulsion is a biphasic liquid preparation containing two immisci- ble liquids, one of which is dispersed as minute globules into the other. The liquid which is converted into minute globule is called the ‘dis- persed phase’ and the liquid in which the globules are persed is called the ‘continuous phase’. Normally, two immiscible liquids cannot be dispersed for a long period. So, an emulsifying agent is added to the system. It forms a film around the globules in order to scatter them indefinitely in the continuous phase, so that a st ble emulsion is formed. The emulsions are of two types: (a) Oil in Water type (oA) emulsion, in which oil is in the dispersed phase whereas water is in the continuous phase. The o/v type emulsions are preferred for internal use. In these emulsions, gum acacia, tragacanth, methyl cellulose, saponins synthetic substances and soaps formed from monovalent bases like Na*, K* and NH4* are used as an emulsifying agent. (b) Water in Qil type (w/o) emulsion, in which water is in the dispersed phase whereas oil is in continuous phase. The wool fat, resins, beeswax and soaps formed from divalent bases like Catt, Mg** and Zn** are used as an emulsifying agent. The w/o emulsions are mainly used extemally as lotions or creams. The following tests are done for distingui emulsions: (8) Dilution test—The emulsion is diluted with water. In case the emulsion remains stable after its dilution, it is o/v emulsion. ion with water but remains ing between ov and w/o The “/o emulsion brea stable when diluted wii (if) Dye test—The scarlet red dye is mixed with the emulsion. Place a drop of the emulsion on a microscope slide, cover it with a cover-slip. and examine it under a microscope. If the disperse globules appear red and the “ground” colourless, the emulsion is ofw type. The reverse condition occurs in w/o type emulsion ie, the disperse globules appear colourless in the red “ground”. Gili) Conductivity test—Water is a good conductor of electricity, whereas oil is non-conductor of electricity. The conductivity test can be performed by dipping a pair of electrodes connected through a low voltage bulb in the emulsion. If the bulb glows on passing the electric current, the emulsion is o/v type, because water is in the continuous phase. In case the bulb does not glow. the emulsion is w/o type. because oil is in the continuous phase. rl INTRODUCTION TO DIFFERENT DOSAGE FORMS 19 (iv) Fluorescence test—Cenain fixed oils possess the physical prop- erty of fluorescing in the presence of ultraviolet radiation. On microscopic examination of emulsion under ultraviolet radiation, the whole field fluorescence indicates that oil is present in continuous phase (w/o type emulsion) and droplets fluorescence indicates that oil is present in disperse phase (o/w type emulsion) The emulsions are of three tyvnec accardine tn their nce) = Thece are