Pharmaceutical Technology PDF

# Pharmaceutical technology ## Solutions - Solutions are liquid pharmaceutical preparations containing one or more pharmaceutical substances dissolved in one or more suitable solvents to produce a single-phase system. ### General procedure for preparation of simple solution 1. Weigh the solid in...

# Pharmaceutical technology ## Solutions - Solutions are liquid pharmaceutical preparations containing one or more pharmaceutical substances dissolved in one or more suitable solvents to produce a single-phase system. ### General procedure for preparation of simple solution 1. Weigh the solid ingredient and put it in a beaker. 2. Subtract the volume of liquid ingredient (if present) in the formula from 3/4 of the final volume of prescription. 3. Dissolve the solid ingredients in the remaining amount of vehicle. 4. Add the liquid ingredient. 5. Convert the content of the beaker into the measuring cylinder and complete the volume up to the required amount by the addition of the vehicle. 6. Transfer the content of the measuring cylinder to a wide-mouth bottle and put a suitable label (label of external use is pink, while label for internal use is white). - The label contains: - Recipe name - Doctor's name - Patient's name - Date - Directions ### Standard solutions (stock solutions) - Are solutions of known concentration (i.e. its concentration exactly measured). These are strong solutions from which weaker solutions are prepared. ### Types of solutions 1. Solutions of liquid in liquid, such as (alcohol in water). 2. Solutions of gas in liquid, such as (ammonia solution). 3. Solutions of solid in liquid, such as (NaCl in water). ### Classification of solutions according to the method of preparation 1. Solutions prepared by the simple solution method. 2. Solutions prepared by chemical reaction. 3. Solutions prepared by simple solution, with sterilization, such as ophthalmic solution, anticoagulant, irrigating sol., physiologic sol. 4. Solutions prepared by extraction. ### Classification of solutions according to their composition 1. Syrups (aqueous solution containing sugar). 2. Elixirs (combination of water and alcohol). 3. Spirits (solution of aromatic materials if the solvent is alcoholic). 4. Aromatic waters (solution of aromatic material if the solvent is aqueous). 5. Tinctures or fluid extracts (solutions prepared by extracting active constituent from crude drugs depending on their method of preparation and their concentration). 6. Injections (solutions prepared to be sterile pyrogen-free and intended for parenteral administration). ### Note: - We can overcome some problems that may occur during the preparation of solutions by the following: - To increase the solubility of substances, we can reduce the particle size by using a mortar and pestle (example: crystal form, large particles). - If we have two solvents in the same prescription, we dissolve the solid substance in the solvent that has more ability to dissolve it (alcohol, water). - If we have material that has very fine particle size, we must not use a stirrer in dissolving it because particles will adhere around the stirrer, so we use circulation of the beaker instead of a stirrer. - If there is liberation of any gas, the container must be opened until the liberation of gas. - Sometimes, we need to increase the solubility by certain methods (ex: pH, complexation). ## Carminative Mixture ### Rx (Carminative mixture for infants) | Ingredient | Quantity | |---|---| | Sodium bicarbonate | 0.06 g | | Aromatic spirit of ammonia | 0.06 ml | | Compound tincture of cardamom | 0.12 ml | | Glycerine | 0.3 ml | | Peppermint water | Q.S. | | | 4 ml | | **Total** | **40 ml** | **Directions:** Take one teaspoonful three times a day after meals. #### Calculations: - Factor = 40/4 = 10 - Sodium bicarbonate = 0.06 x 10 = 0.6 g - Aromatic spirit of ammonia = 0.06 x 10 = 0.6 ml - Compound tincture of cardamom = 0.12 x 10 = 1.2 ml - Glycerine = 0.3 ml x 10 = 3 ml - Peppermint water = 4 x 10 = 40 ml - 40 x 3/4 = 30 ml - 30 ml - (3 ml + 1.2 ml + 0.6 ml) = 25.2 ml #### Procedure: 1. Dissolve 0.6 g sodium bicarbonate in 25.2 ml of peppermint water in a beaker. 2. Add 0.6 ml aromatic spirit of ammonia, 1.2 ml of compound tincture of cardamom, and then add 3 ml of glycerine to the content of the beaker. 3. Convert the content of the beaker into the measuring cylinder and complete the volume up to 40 ml by the addition of peppermint water. 4. Transfer the content of the measuring cylinder to a wide-mouth bottle and put a suitable label. #### Note: Glycerine acts as a soothing and sweetening agent. ### Rx (Carminative mixture for adult) | Ingredient | Quantity | |---|---| | Sodium bicarbonate | gr vii | | Aromatic spirit of ammonia | m xv | | Compound tincture of cardamom | m x | | Strong tincture of ginger | mi | | Peppermint water | Q.S.| | | ζί | | **Total** | **ζίν** | **Directions:** Take half a teaspoonful three times a day after meals. #### Procedure: - Same as the procedure of the carminative mixture for infants. #### Notes: - Sodium bicarbonate acts as a gastric antiacid. - Aromatic spirit acts as a carminative agent. - Compound tincture of cardamom acts as a flavoring agent. - Tincture of ginger acts as a flavoring and antispasmodic agent. Also, it is a diluting agent, used as a solvent. - Strong tincture of ginger which is used in the carminative mixture of adults must not be added for infants because it is strong for use with infants. ## Iodine Solutions 1. Aqueous Iodine Solution (Lugol's Solution). 2. Weak Iodine Solution (Mites' Solution). 3. Strong Iodine Solution (Fortis Solution). 4. Mandle's Paint (throat paint). ### Rx (Aqueous iodine solution, Lugol's solution) | Ingredient | Quantity | |---|---| | Iodine | 50 g | | Potassium iodide | 100 g | | Purified water | Q.S. | | | 1000 ml | | **Total** | **25 ml** | **Directions:** Take 0.3 ml diluted with milk or water three times a day. #### Procedure: 1. Dissolve iodine in a concentrated potassium iodide solution. 2. Shake well until iodine is dissolved. 3. Complete the volume with purified water to 1000 ml. #### Notes: - Lugol's solution used internally in the treatment of thyrotoxicosis (preoperative treatment) and in hypothyroidism. - We dissolve the iodine in potassium iodide instead of water because iodine has better solubility in potassium iodide than in water. ### Rx (Weak Iodine Solution, tr.iodine) | Ingredient | Quantity | |---|---| | Iodine | 25 g | | Potassium iodide | 15 g | | Distilled water | 25 ml | | Alcohol 90% | Q.S. | | | 1000 ml | | **Total** | **25 ml** | **Directions:** Use externally twice daily. #### Procedure: The same method as Lugol's solution, except completing the volume with Alcohol 90% to 1000 ml. ### Rx (Strong Iodine Solution) | Ingredient | Quantity | |---|---| | Iodine | 100 g | | Potassium iodide | 60 g | | Distilled water | 100 ml | | Alcohol 90% | Q.S. | | | 1000ml | | **Total** | **25 ml** | #### Note: Weak and strong iodine solutions are used as antiseptics. ### Rx (Mandle's paint, throat paint) | Ingredient | Quantity | |---|---| | Potassium iodide | 25 g | | Alcohol 90% | 40 ml | | Water | 25 ml | | Iodine | 12.5 g | | Peppermint oil | 4 ml | | Glycerol | Q.S. | | | 1000 ml | | **Total** | **25 ml** | #### Note: - Throat paint is used for tonsillitis and pharyngitis. #### Procedure: 1. Dissolve 25 g of potassium iodide in 25 ml of water. 2. Dissolve 12.5 g of iodine in the Potassium iodide solution. 3. Dissolve 4 ml of peppermint oil in 40 ml of 90% alcohol, and transfer it to the iodine solution. Then, mix. 4. Complete the volume to 1000 ml by glycerine. #### Note: - Iodine is used as an antiseptic. - Glycerol is used as a preservative. - Peppermint oil is used as a flavoring agent. - This paint is dispensed in colored bottles with a stopper. ## Sol. I and Sol. II | Solution | Ingredient | Concentration| |---|---|---| | Sol. I | Sodium thiosulphate | 15-20% | | Sol. II | Tartaric acid | 3-5% | **Directions:** Apply solution I and then, after two minutes, apply solution II on the skin. #### Procedure: By simple solution method. #### Notes: - This prescription is used as an antifungal. - We cannot mix solution I and solution II in the same bottle due to the chemical reaction between them, which we use to precipitate the sulfur in the infected area of skin as an antifungal. ## Nasal Drops - Nasal drops are aqueous or oily solutions that are designed to be applied to the nasal passages in drop or spray form. These are commonly used for their antiseptic, local analgesic or vasoconstrictor properties. - Nasal drops must be isotonic with nasal secretion and have the same pH of nasal secretion. ### Rx (Ephedrine Nasal Drop) | Ingredient | Quantity | |---|---| | Ephedrine HCl | 500 mg | | NaCl | 500 mg | | Chlorobutol | 500mg | | D.W | Q.S. | | | 100 ml | | **Total** | **50 ml** | **Directions:** Place two drops into each nostril as directed. #### Procedure: 1. Dissolve 250 mg of chlorobutol in 37.5 ml of hot water. 2. Add 250 mg of ephedrine HCl and 250 mg of NaCl to the solution. 3. Complete the volume up to 50 ml with water. #### Notes: - Ephedrine HCl is used as a vasoconstrictor (decongestant). - Chlorobutol has low solubility in water but it is more soluble in hot water. - Chlorobutol is used as a preservative, antiseptic, mild sedative and local analgesic. - Sodium Chloride is used to maintain osmotic pressure. ## Ear Drops - These are mostly simple solutions of drugs dissolved in a suitable solvent(s), applied into the ear by dropper. - (Ex. On solvent: glycerine, propylene glycol, alcohol, water, or alcohol-water mixture). - Ear drops are used as antibiotic, wax softener, cleansing solution. ### Rx (Sodium bicarbonate ear drop) | Ingredient | Quantity | |---|---| | Sodium bicarbonate | 5 g | | Glycerine | 30 ml | | D.W | Q.S.| | | 100 ml | | **Total** | **50 ml** | **Directions:** As directed #### Calculation: - Factor = 50/100 = 0.5 - Sodium bicarbonate = 5 x 0.5 = 2.5 g - Glycerine = 30 x 0.5 = 15 ml - D.W = 100 x 0.5 = 50 ml - 50 x 3/4 = 37.5 ml - 37.5 - 15 = 22.5 ml #### Procedure: 1. Dissolve 2.5 g of sodium bicarbonate in 22.5 ml of D.W. 2. Add 15 ml of glycerine. 3. Complete the volume up to 50 ml with D.W. #### Notes: - Nasal drops are used internally while ear drops are used externally because the outer ear is a skin-covered structure and susceptible to the same dermatologic conditions as other parts of the body's surface. - Sodium bicarbonate is used for softening wax. - Glycerine is used as a preservative and lubricant, it increases the viscosity so it gives a suitable time for the drug to be effective. - Sodium bicarbonate ear drops should be freshly prepared. ## Gargles - Are aqueous solutions used for the treatment of the pharynx and nasopharynx by forcing air from the lung, it is held in the throat for a few moments, then thrown out of the mouth. - They are usually diluted with water before use, such as phenol gargle, P.T.A. gargle. ### Rx (Potassium chlorate and phenol gargle) B.P | Ingredient | Quantity | |---|---| | Potassium chlorate | 3 g | | Patent blue v | 2 ml | | Liquid phenol | 1.5 ml | | D.W | Q.S. | | | 100 ml | | **Total** | **50 ml** | **Directions:** Take one tablespoonful in half a glass of warm water. #### Procedure: 1. Dissolve the potassium chlorate in about 15 ml of warm water. 2. Cool before adding the liquefied phenol (very caustic). 3. Add the dye solution, filter if necessary. 4. Complete the volume by D.W. #### Note: - Stock solution of patent blue v contains 60mg/100ml. - Potassium chlorate is used as an anti-inflammatory. - Patent blue is used as a coloring agent. - Liquid phenol is used as an antiseptic. ## Mouth Wash - Are aqueous solutions, most often used for their deodorant, refreshing, or antiseptic effect. They may contain alcohol, glycerine, sweetener, flavoring agent. ### Rx (Compound sodium chloride mouth wash). B.P. | Ingredient | Quantity | |---|---| | NaCl | 1.5 mg | | Na bicarbonate | 1 mg | | Peppermint water | Q.S. | | | 100 ml | | **Total** | **50 ml** | **Directions:** Use with equal volume of warm water. #### Procedure: By simple solution method. #### Note: Mouth washes are usually less medicated and more flavored than gargles. ## Syrups - Are sweet, viscous aqueous liquids. - Medically, they are divided into two types: - **Nonmedicated syrups (flavoring syrups)**: These are intended to serve as pleasant-tasting vehicles for medicinal substances. (Ex: cherry syrup, orange syrup, simple syrup.) - **Medicated syrups**: These contain ingredients giving them therapeutic value. (Ex: Antitussives, antihistamines) ### Pharmaceutical classification of syrups according to their basic formulation: 1. **Sugar-based syrups**: These are concentrated solutions of sugar (Ex: Sucrose, dextrose). 2. **Sugar-free syrups**: These are formulated with artificial sweetening agent (Ex: Sorbitol) #### Note: - The use of sucrose is preferred in pharmaceutical preparations due to: - It's purity. - Degree of sweetness. - Lack of color. - Ease of handling. - Inertness. - Sucrose is subjected to two degradative pathways: - Fermentation - Hydrolysis #### Fermentation of sucrose: - Sucrose, as a carbohydrate, in a dilute solution provides nutrient media for the growth of micro-organisms (molds, yeasts). - Signs of micro-organism growth include: - Turbidity (change in color). - Fermentation (change in odor). - Change in taste. - The concentration of sucrose is an important factor in the inhibition of mold growth. The saturated solution of sucrose if stored properly will be self-preserving (contain no free water, thus they behave as anhydrous media with respect to the growth of micro-organisms and this will lead to shrinkage and lysis of micro-organisms.). #### Hydrolysis of sucrose: - Sucrose is a disaccharide and can be hydrolyzed to give monosaccharides (dextrose, fructose) - The hydrolytic reaction is acid-specific (i.e. hydrogen catalyzed). This reaction is called inversion. - The invert sugars (dextrose, fructose) have specific properties: - They are fermented more easily than sucrose. - They are sweeter than sucrose. - Degradation of fructose (which is formed by inversion) is responsible for the brown color of some colorless syrups. This change is called caramelization, which takes place in syrups containing acids. ### Storage of syrups: - Generally, syrups are stored at room temperature, in tightly stoppered, well-filled bottles. Saturation and refrigeration will inhibit both mold growth and inversion, but less that 4°C will cause crystallization (large crystals are formed and it is difficult to redissolved). ### Rx (Simple syrup) B.P. | Ingredient | Quantity | |---|---| | Sucrose | 667 g | | D.W | Q.S | | | 1000 g | | **Total** | **100 ml** | #### Method: 1. Weigh the beaker empty and weigh the sucrose in it. 2. Add a small quantity of water with stirring to dissolve the sucrose on gentle heating (using a water bath). 3. Weigh again to complete the weight with hot water. ### Rx (Simple syrup) U.S.P | Ingredient | Quantity | |---|---| | Sucrose | 850 g | | D.W | Q.S | | | 1000 ml | | **Total** | **100 ml** | #### Method: Prepared by using boiling water. ### Rx (Ipecac syrup) | Ingredient | Quantity | |---|---| | Ipecac fluid extracts | 70 ml | | Glycerine | 100 ml | | Simple syrup | Q.S. | | | 1000 ml | | **Total** | **100 ml** | **Directions:** Take half a teaspoonful three times a day after meals. #### Method: Mix the fluid extract with glycerine, then add enough syrup to make the product measure 1000 ml, and mix thoroughly. #### Note: - Ipecac is used as an expectorant in small doses (25 – 100 mg). In larger doses, it is used as an emetic agent (vomiting occurs within 30 minutes, due to irritation of the gastrointestinal tract. - The emetic dose for adults is 10 – 30 ml, and for children is 10 – 15 ml. ### Tolu balsam syrup. U.S.P. | Ingredient | Quantity | |---|---| | Tincture of tolu balsam | 50 ml | | Magnesium carbonate | 10 g | | Sucrose | 820 g | | D.W | Q.S. | | | 1000 ml | | **Total** | **100 ml** | **Directions:** Take half a teaspoonful as needed. #### Method: 1. Mix the tolu balsam tincture with 10 g of magnesium carbonate and 60 g of sucrose in a mortar. 2. Gradually add 430 ml of D.W. with trituration and filter. 3. Dissolve the remainder of the sucrose (760 g) in the clear filtrate with gentle heating (not over 50°C). 4. Strain the syrup while warm and add D.W. through a strainer to make the product measure 1000 ml, and mix thoroughly. #### Notes: - Tolu balsam syrup is used as an expectorant, flavoring agent. - Tolu balsam is soluble in alcohol, ether, chloroform, but it is insoluble in water because it contains resins. - Magnesium carbonate is very soluble in water and partially soluble in alcohol. - Magnesium carbonate is used as a distributing agent for tolu balsam tincture because it is alkaline and this helps in dissolving the resinous content of tolu balsam. ### Rx (Mist. Diuretic) (acidic) | Ingredient | Quantity | |---|---| | Potassium citrate | 300 g | | Citric acid | 50 g | | Lemon spirit | 5 ml | | Quillaia tincture | 10 ml | | Syrup | 250 ml | | Chloroform water double strength | 300 ml | | Water | Q.S. | | | 1000 ml | | **Total** | **?** | #### Method: 1. Dissolve the solids in a mixture of the chloroform water and syrup by shaking or vigorous stirring. 2. Add quillaia tincture and shake. 3. Add lemon spirit in small amounts, shake after each addition. 4. Complete the volume and mix. #### Notes: - Double strength chloroform water is twice the concentration of ordinary aromatic water. - Acidic diuretic mixture is used for hypertensive patients. ### Rx (Mist. Diuretic) (alkaline) | Ingredient | Quantity | |---|---| | Potassium citrate | 20 g| | Sodium bicarbonate | 20 g | | Concentrate Infusion of bucha | 20 ml| | Syrup of orange | 40 ml | | Chloroform water | Q.S. | | | 300 ml | #### Method: 1. Weigh the solids and dissolve them in the mixture of chloroform and syrup by shaking. 2. Add concentrate infusion of bucha. 3. Complete the volume and mix. #### Note: - Acidic diuretic mixture is used for hypertensive patients instead of alkaline. ## Dextorse based syrup - Dextrose is used instead of sucrose, in syrups containing strong acids to prevent caramelization. ### Differences between sucrose and dextrose 1. The saturated solution of dextrose is 70%, so the dextrose-based syrup is susceptible to the growth of micro-organisms, therefore, we must add a preservative. 2. Dextrose dissolves more slowly than sucrose. 3. The sweetness of dextrose is less than the sweetness of sucrose. #### Note: - We may use glycerine as a preservative in dextrose-based syrups, why? ### Rx (Hypophosphite syrup) | Ingredient | Quantity | |---|---| | Calcium hypophosphite | 35g | | Potassium hypophosphite | 18g | | Sodium hypophosphite | 18g | | Hypophosphorus acid | 1 ml | | Dextrose | 250 g | | Glycerine | 300 ml | | D.W | Q.S. | | | 1000 ml | #### Method: 1. Dissolve Calcium, Sodium, and Potassium hypophosphite in water. 2. Mix hypophosphorus acid, dextrose, and glycerine in a bottle. 3. Filter the first mixture over the second mixture in a bottle. 4. Shake from time to time until the solution is completely dissolved. 5. Transfer the mixture into a graduated cylinder and complete the volume. #### Note: - This prescription is used as a tonic and in deficiency of electrolyte. ## Sugar-free syrup (non-nutritive syrup) - It is also called an artificial syrup. This type of syrup is given to patients suffering from diabetes mellitus. ### General formula of non-nutritive syrups: 1. Sweetening agent: sorbitol, saccharine, aspartame. 2. Viscosity builder: carboxymethyl cellulose (CMC), sodium alginate. 3. Preservative: benzoic acid, sodium benzoate. 4. Purified water. ### Sorbitol based syrup - Sorbitol has the following properties: - Used in non-nutritive syrups for diabetic patients (not cause hyperglycemia). - Not cause dental carries. - Sorbitol is 60% as sweet as sucrose. - Has a good taste. - Not need a preservative if its concentration is more than 60% (w/w). - Chemically stable. - Not absorbed from the gastrointestinal tract as rapidly as sucrose. - Not irritating to the mouth and throat membranes. - Has a laxative effect if ingested in a large quantity. - Has half the viscosity of simple syrup. ### Rx (Sorbitol solution) U.S.P. | Ingredient | Quantity | |---|---| | Sorbitol | 70 g | | D.W | 100 g | #### Method: - By simple solution method. ## Chloral Hydrate Syrup ### Rx (Chloral hydrate syrup) U.S.P. | Ingredient | Quantity | |---|---| | Chloral hydrate | 0.5 g | | Simple syrup | Q.S. | | | 100 ml | **Directions:** Take a half-teaspoonful at night. #### Method: - Dissolve chloral hydrate in 75 ml of simple syrup, stir well, filter. Then, complete the volume of the filtrate to 100 ml by simple syrup. ### Rx (Chloral hydrate syrup (non-official)) | Ingredient | Quantity | |---|---| | Chloral hydrate | 0.5 g | | Sorbitol | 70 g | | D.W | Q.S. | | | 100 ml | #### Method: 1. Dissolve chloral hydrate and sorbitol in 75 ml of water. 2. Stir well to enhance solubility. 3. Strain by cotton. 4. Complete the volume to 100 ml with D.W. ## Spirits - Are alcoholic or hydroalcoholic solutions of volatile principle (mostly volatile oil). #### Notes: - Spirits could be classified according to their uses: - **Therapeutic spirits**: which contain therapeutic volatile substances. - **Flavoring spirits**: which contain flavoring volatile substances. - Spirits are also known as essences. - Spirits are prepared by distillation. But now, they are prepared by dissolving the volatile substances in alcohol. - The amount of volatile substance in spirits varies greatly and no fixed percentage can be given, but in all cases, volatile substance in the spirit is more than that of aromatic water. - The amount of alcohol differs from one spirit to another. The lowest amount of alcohol found in internal spirits is (aromatic spirit of ammonia), which contains 62 – 68% alcohol, while (camphor spirit), which is used externally, contains 80 – 87% alcohol. - When a spirit is taken orally, it is generally mixed with portions of water to reduce pungency of spirit. - In the preparation of a spirit, we must keep in mind that the oil dissolved in alcohol will precipitate causing turbidity when the solution is mixed with water other than that specified in the formula, so all equipment should be dry, and filter paper should be moistened with alcohol. - Spirits should be stored in light-resistant containers and in a cool place to prevent evaporation of alcohol and the volatilization of volatile substances or active ingredients and to limit oxidative changes. ### Methods of preparation of spirit: 1. Simple solution method. 2. Maceration. 3. Chemical reaction. 4. Distillation. ### Rx (Spirit Of Orange) B.P. | Ingredient | Quantity | |---|---| | Oil of orange | 200 ml | | Oil of lemon | 50 ml| | Oil of coriander | 20 ml | | Oil of anise | 5 ml | | Alcohol | Q.S | | | 1000 ml | #### Method: According to the simple solution method, mix oils with sufficient alcohol to make the product measure 1000 ml. #### Note: Anise oil is used as a carminative and mild expectorant (as in cough mixtures and lozenges). ### Rx (Compound spirit of cardamom) B.P | Ingredient | Quantity | |---|---| | Oil of cardamom | 20 ml | | Oil of orange | 20 ml | | Oil of cinnamon | 2 ml | | Oil of clove | 1 ml| | Anethol | 1 ml | | Oil of caraway | 0.2 ml | | Alcohol | Q.S | | | 200 ml | #### Method: Mix the oils and anethol with sufficient alcohol to make the product measure 200 ml. #### Notes: - Caraway oil is used as an antispasmodic agent, mainly in children's mixtures. - Cinnamon oil is used as a carminative and flavoring agent. - Cardamom oil is used as a carminative and flavoring agent. - Anethol is used as a mild expectorant in cough mixtures and lozenges, also as a flavoring agent. ### Rx (Aromatic spirit of ammonia) | Ingredient | Quantity | |---|---| | Ammonium carbonate | 34 g | | Dilute solution of ammonia | 90 ml | | Oil of lemon | 10 ml | | Oil of lavender | 1 ml | | Oil of myristica | 1 ml | | Alcohol | 700 ml | | D.W | Q.S. | | | 1000 ml | #### Method: Dissolve the solid agent in the dilute solution of ammonia with little amounts of water while the oil is dissolved in alcohol, also with little amounts of water. Then add the aqueous solution into the alcoholic solution, after filtering each one. #### Note: - In the preparation of aromatic spirit of ammonia, we make filtration due to the presence of water with alcohol which will lead to the precipitation of volatile oils. ### Uses of official spirits: 1. Carminative (aromatic spirit of ammonia). 2. Antacid (aromatic spirit of ammonia). 3. Mild reflex circulatory stimulant (camphor spirit). 4. Flavoring agent (cinnamon spirit). ## Elixirs - Are clear, sweetened, hydroalcoholic solutions intended for oral use, and are usually flavored to enhance their palatability. - Medically, they are classified: - **Non-medicated elixirs**: which are employed as vehicles for medicinal substances. (Ex: Elixir of glycerine). - **Medicated elixirs**: which contain ingredients giving them therapeutic value. #### Notes: - The proportion of alcohol present in elixirs varies widely since the individual components of the elixirs have different water and alcohol solubility characteristics (each elixir requires a specific blend of alcohol and water to maintain all components in solution). - In addition to alcohol and water, other ingredients may be used in elixirs, such as: - Glycerin and polypropylene glycol, which are used as adjunct solvents. - Sucrose, saccharine, and sorbitol as a sweetening agent. - Flavoring materials to increase their palatability. - Coloring agents to enhance their appearance. - Elixirs containing over 10 - 12% of alcohol are usually self-preserving. - Elixirs should be stored in tight, light-resistant containers and protected from excessive heat due to volatile oils and alcohol. ### Differences between elixirs and syrups 1. **Elixirs are usually less sweet and less viscous than syrups** because they contain a lower proportion of sugar and consequently are less effective than syrups in masking the taste of medicinal substances. 2. **Elixirs are better able than aqueous syrups**, to maintain both water soluble and alcohol soluble components in solution because of their hydro-alcoholic character. 3. **From a manufacturing standpoint, elixirs are preferred over syrups**, due to their stability and ease of preparation (by simple solution). ### Preparation of elixirs: 1. **Elixirs are usually prepared by simple solution**, with agitation and/or by the admixture of two or more liquid ingredients. 2. **Alcohol-soluble and water-soluble components are generally dissolved separately** in alcohol and in purified water, respectively. 3. **Then, the aqueous solution is added to the alcoholic solution**, rather than the reverse, in order to maintain the highest possible alcoholic strength at all times so that minimal separation of the alcohol-soluble components occurs. When the two solutions are completely mixed, the mixture is made to volume, with the specified solvent or vehicle. #### Note: - In the preparation of elixirs, frequently, the final mixture will not be clear (cloudy) due to separation of some of the flavoring oils, by reduced alcoholic concentration. If this occurs, the elixir is usually permitted to stand for a prescribed number of hours, to ensure the saturation of the hydro-alcoholic solvent and to permit the oil globules to coalesce so that they may be more easily removed by filtration. ### Comparison between elixirs and spirits. | Category | Elixirs | Spirits | |---|---|---| | Sweetening agent | Contain | Do not contain | | Viscosity | More viscous | Less viscous | | Preservative | Need if the alcohol content is less than 10-12% | Do not need | | Solvents | Water and alcohol | Alcohol | | Uses | Internal use only | Internal and external use | | Alcohol concentration | 4-40% | 62-87% | ### Rx (Phenobarbital elixir) U.S.P. | Ingredient | Quantity | |---|---| | Phenobarbital | 4 g | | Tincture Of Orange Peel | 30 ml | | Solution of Amaranth | 10 ml | | Alcohol | 125 ml | | Glycerine | 450 ml | | Syrup | 250 ml | | D.W | Q.S. | | | 1000 ml | #### Method: 1. Dissolve the phenobarbital in alcohol. 2. Add the tincture of orange peel, glycerine, syrup, amaranth solution and add sufficient water to produce 1000 ml. Mix well and filter. #### Notes: - Phenobarbital elixir is used as a sedative and hypnotic. - Glycerin is used as a thickening agent, also it increases the solubility of phenobarbital. - Tincture of orange peel is used as a flavoring agent. - Solution of amaranth is used as a coloring agent. - Syrup is used as a sweetening agent. ### Rx (Pediatric paracetamol elixir) B.P. | Ingredient | Quantity | |---|---| | Paracetamol | 120 mg | | Alcohol | 0.5 ml | | Chloroform spirit | 0.1 ml | | Propylene glycol | 0.5 ml | | Concentrate Rose berry juice | 0.125 ml | | Amaranth solution | 0.01 ml | | Invert syrup | 1.375 ml | | Glycerol | Q.S. | | | 5 ml | **Directions:** As directed. #### Method: 1. Dissolve paracetamol in alcohol. 2. Add chloroform spirit, propylene glycol, juice, amaranth solution, invert syrup. 3. Complete the volume by the addition of glycerol. ## Disperse Systems - Disperse system composed from: - **Dispersed phase**: which is the substance distributed. - **Dispersion medium**: which is the vehicle. ### Type of dispersion according to dosage form: 1. **Emulsion (liquid in liquid)**. 2. **Ointment, paste (solid in solid)**. 3. **Suspension (solid in liquid)**. ### Type of dispersion according to particle size: 1. **Coarse dispersion (10 – 50 µm)**. 2. **Fine dispersion (0.5 – 10 µm)**. 3. **Colloidal dispersion (1 nm – 0.5 µm)**. ## Suspension