Pharmaceutical Technology: Spirit & Elixir PDF

# Pharmaceutical Technology ## Spirit & Elixir - Dr. Shafaq Al-Azzawi ## Spirits - Spirits are alcoholic or hydroalcoholic solutions of volatile substances. Generally, the alcoholic concentration of spirits is rather high, usually over 60% - Sometimes spirits are known as Essence - Spirits may be u...

# Pharmaceutical Technology ## Spirit & Elixir - Dr. Shafaq Al-Azzawi ## Spirits - Spirits are alcoholic or hydroalcoholic solutions of volatile substances. Generally, the alcoholic concentration of spirits is rather high, usually over 60% - Sometimes spirits are known as Essence - Spirits may be used * pharmaceutically as flavoring agents * medicinally for the therapeutic value of the aromatic solute. - They may be taken orally (they are generally mixed with a portion of water to reduce the pungency of the spirit), applied topically, or used by inhalation. ## Spirit - The spirits most recently official in the USP-NF are: 1. Aromatic ammonia spirit (used orally as carminative & antacid and by inhalation in cases of fainting) 2. Camphor spirit (used topically for relief of minor pains & aches) 3. Compound orange spirit (used orally as flavoring agent) 4. Peppermint spirit (used orally as carminative & flavoring agent) ## Compound Orange Spirit - Oil of orange: 20ml - Oil of lemon: 50 ml - Oil of coriander: 20 ml - Oil of anise: 5ml - Alcohol: q.s 1000ml ### Procedure: 1. Take 20ml of oil of orange, 50 ml oil of lemon, 20 ml oil of coriander & 5ml oil of anise and mix them with sufficient volume of alcohol. 2. Transfer the mixture to a clean and dry graduated cylinder and complete the volume to 1000 ml with alcohol. 3. Transfer the resultant solution to a clean bottle and label it. ### Uses: - Oil of orange: used as flavoring agent - Oil of lemon: used as flavoring agent - Oil of coriander: used as flavoring agent - Oil of anise: used as flavoring, carminative & mild expectorant agent - Alcohol: used as solvent & preservative ## Elixir - Elixirs are clear, sweetened hydroalcoholic solutions intended for oral use and are usually flavored to enhance their palatability. - Main ingredient in elixir is ethanol & water, but they also can contain other ingredients: * Glycerin and propylene glycol which used as adjunct solvents. * Sucrose, saccharine, and sorbitol as sweetening agent * Flavouring materials to increase their palatability. * Colouring agents to enhance their apperance. - Medically they are classified to: 1. Non medicated elixirs 2. Medicated elixirs - Alcoholic content varies from 4-40%, generally there is enough alcohol just to keep the volatile oil or medicinal substance in solution. - Elixirs containing over 10-12% of alcohol are usually self preserving and don't require preservatives or antimicrobial agents. - Elixirs are usually prepared by simple solution method with agitation and/or by the admixture of two or more liquid ingredients. - Alcohol soluble and water soluble components are generally dissolved separately in alcohol and purified water, respectively. Then the aqueous solution is added to alcoholic solution rather than the reverse, in order to maintain the highest possible alcoholic strength at all times so that minimal separation of alcohol-soluble components occurs. - In preparation of elixirs frequently the final mixture will not be clear (cloud) due to separation of some flavoring oils by reduced alcoholic concentrations. If this occurs the elixir is usually permitted to stand to permit the oil globules to coalesce so that they are more easily removed by filtration, and talc, a frequent filter aid in the preparation of elixirs, absorbs the excessive amounts of oils and therefore assists in their removal from the solution. ## Phenobarbital Elixir - Phenobarbital: 4g - Tincture of orange peel: 30 ml - Amaranth sol: 10 ml - Alcohol: 125 ml - Glycerin: 150 ml - Syrup: 250 ml - D.W: q.s 1000 ml * Sig/ one tablespoonful at night ### Calculations - Volume of slovent required = 3/4 total volume = 3/4 x 1000ml = 750ml - Volume of liquid ingredients = 30+10+125+150+250 ml = 565 ml - Volume required for initial dissolution = 750ml-565ml = 185 ml ### Procedure 1. Weigh 4g of phenobarbital by using the balance and transfer it to a clean beaker, measure 30 ml of tin. of orange peel, 10ml of amaranth sol., 125ml of alcohol, 150ml of glycerin & 250ml of syrup using graduated cylinder. 2. Dissolve phenobarbital in alcohol and then add the liquid ingredients (tin. of orange peel, glycerin, syrup and amaranth sol.) and add 185ml of D.W and mix them well and filter if needed. 3. Transfer the mixture to the cylinder and complete the volume to 1000ml by D.W. 4. Transfer the solution to the bottle and label it by writing the name of product, direction of use and the date of production. ### Uses: - Phenobarbital: used as sedative & hypnotic - Tincture of orange peel: used as flavoring agent - Amaranth solution: used as coloring agent - Alcohol: used as solvent - Glycerin: used as thickening agent & increase solubility of phenobarbital - Syrup: used as sweetening agent - D.W: used as solvent ## Aromatic Elixir USP - Compound spirit of orange: 12ml - Syrup: 375 ml - Talc powder: 30g - Alcohol 70%: a.a. q.s 1000ml - D.W: a.a. q.s 1000ml * Mitt: 10ml - Note: available alcohol 90% ### Calculations - Factor = Desired volume/Given volume = 10ml / 1000ml = 0.01 - Compound spirit of orange: 12 x 0.01 = 0.12ml - Syrup: 375 x 0.01 = 3.75 ml - Talc powder: 30 x 0.01 = 0.3g - Alcohol 70%: a.a. q.s 1000 x 0.01 = 10ml - D.W: a.a. q.s 1000 x 0.01 = 10 ml * - Volume of co-slovent required = 3/4 total volume = 3/4 x 10ml = 7.5 ml * - Volume of liquid ingredient = 0.12+3.75 = 3.87 ml * - Volume required for initial dissolution = 7.5ml - 3.87 ml = 3.6 ml ≈ 3.5 ml * Co- solvent: 10 ml means 5 ml alcohol 70% & 5 ml D.W * Preparation of 5 ml of alcohol 70% * C1 x V1 = C2 x V2 * 90% x V2 = 70% x 5ml * V2 = 3.8ml from alcohol 90% & complete the volume to 5ml with D.W. ### Procedure 1. Weigh 0.3g of talc powder by using the balance and transfer it to a clean beaker, measure 0.12ml of compound spirit of orange & 3.75 ml of syrup using graduated cylinder. 2. Prepare 5 ml of alcohol 70% by taking 3.8 ml of alcohol 90 % and complete the volume to 5 ml with D.W. 3. Prepare the co-solvent by taking the previously prepared 5ml of alcohol 70% and 5 ml D.W and mix them together. 4. Measure 3.5 ml from the prepared co-solvent and add it to the beaker containing talc powder and dissolve it, then add 0.12 ml of compound spirit of orange & 3.75 ml of syrup. 5. Filter the resultant solution and then transfer it to clean cylinder and complete the volume to 10ml with the prepared co-solvent. 6. Transfer the final solution to the bottle and label it. ### Uses: - Compound spirit of orange: used as flavoring agent - Syrup: used as sweetening agent - Talc powder: used to adsorb the excess of oil droplets - Alcohol: used as solvent - D.W: used as solvent ## Homework Compare between Elixir & Spirit as following : | Properties | Elixir | Spirit | |---|---|---| | Alcoholic content (%) | | | | Viscosity | | | | Major Solvent (s) | | | | Preservatives (need or not) | | | | Sweetening agents (need or not) | | | | Use (oral, topical or other) | | |