MONOPHASIC LIQUID DOSAGE FORMS

MONOPHASIC LIQUID DOSAGE FORMS. SOLUTION:. “A solution is a liquid-preparation that contains one or more soluble chemical substances dissolved in a specified solvent.” Advantages Immediately available for absorption

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MONOPHASIC LIQUID DOSAGE FORMS

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MONOPHASIC LIQUID DOSAGE FORMS
SOLUTION: • “A solution is a liquid-preparation that contains one or more soluble chemical substances dissolved in a specified solvent.” • Advantages Immediately available for absorption Useful for hygroscopic drugs which must be administered as a solution • Disadvantages Less stable Incompatibility is faster Bacterial contamination
A. Aqueous liquids: Water Purified Water Water for injection Sterile water for injection Bacteriostatic water for injection B. Oils &oily materials: Animals source…pig fat Vegetable Source…corn,cotton Mineral Source…liquid paraffin Synthetics….ethyl oleate C. Hydroxylated Compounds: Ethanol Propylene Glycol D. Hydro-alcoholic Mixtures E. Modern Vehicles: Dioxalanes Solvent for aerosol sprays Dimethylecetamide Solvents used
-Vehicle for the internal Use 1. Purified Water 2.Aromatic Water a. Chloroform Water b. Peppermint Water c. Cinnamon Water d. Dill Water - vehicles for external use Isopropyl myristate Liquid Paraffin -vehicles for extraction Isopropyl Alcohol Acetone
Formulation Consideration • 1) Solubility a) pH b) Cosolvency c) Solubilization d) Complexation e) Hydrotrophy f) Chemical modification of the drug molecule 2) Preservation a) Preservatives b) Antioxidants c) Reducing agents d) Synergists 3) Organoleptic consideration a) Sweetening agents b) Flavoring agents c) Coloring agents d) Viscosity control e) Overall appearance 4) Stability a) Chemical stability b) Physical stability
1.SOLUBILITY • Expression of solubility According to Indian Pharmacopoeia Descriptive Phrase - Approximate quantities(ml) of solvent by volume for 1 part (1 gm) of solute by weight Very soluble - less than 1 part Freely soluble - from 1 to 10 parts Soluble - from 10 to 30 parts Sparingly soluble - from 30 to 100 parts Slightly soluble - from 100 to 1000 parts Very slightly soluble - from 1000 to 10,000 parts Practically insoluble - more than 10,000 parts
a. pH A large number of drugs are either weak acids or weak bases. The solubility of these agents can be markedly influenced by the pH of the environment • Weak Acid pH = pKa + log (ionised ) /(un ionised) pH = pKa + log (base) / (acid) Weak Base pH=pKa +log (unionised) / (ionised) pH = pKa+ log( base )/(acid) b. COSOLVENCY Weak electrolytes and nonpolar molecules frequently have poor water solubility. These types of solutes are more soluble in a mixture of solvents than in one solvent alone. This phenomenon is known as cosolvency.
c. DIELECTRIC CONSTANT One property of a solvent system is its dielectric constant. The dielectric constant of a solvent can be defined as the ratio of the capacitances of a capacitor filled with the solvent and air respectively. d. SOLUBILIZATION spontaneous increase of solubility of a poorly water-soluble solute molecules into an aqueous solution of surface active agents (or surfactants) in which a thermodynamically stable solution is formed.
e. COMPLEXATION Solubility of a compound may be increased by complexing with a complexing agent. e.g. solubility of para amino benzoic acid (PABA) may be increased by complexing with caffeine f. HYDROTROPHY The term hydrotrophy has been used to designate the increase in solubility in water of various substances due to the presence of large amounts of additives. g. CHEMICAL MODIFICATION OF DRUG Poorly soluble drugs are chemically modified into water soluble derivatives.
2.PRESERVATION a.Preservatives Some pharmaceutically useful preservative Class -------Preservative ------Usual concentration (%) -Acidic Phenol - 0.2 - 0.5 Chlorocresol - 0.05 - 0.1 -Neutral Chlorbutanol - 0.5 Benzyl alcohol - 1.0 -Mercurial Thiomersal - 0.001 - 0.1 Nitromersol - 0.001 - 0.1 -Quarternary ammonium compoundsBenzalkonium chloride - 0.004 - 0.02 Cetylpyridinium - 0.01 - 0.02
b. Antioxidants An antioxidant is a molecule that inhibits the oxidation of other molecules c. Reducing agent A reducing agent (also called a reductant or reducer) is the element or compound in a reduction-oxidation reaction that donates an electron to another species however, since the reducer loses an electron we say it is "oxidized". This means that there must be an "oxidizer"; because if any chemical is an electron donor (reducer), another must be an electron recipient (oxidant).
3.ORGANOLEPTIC ADDITIVESa. Colouring Agents • Colouring Agents generally used in case of cosmetic preparations. • The second reasons is to distinguish one product from the products. A third reason is to distinguish the preparation being administered • Classification- 1.natural colouring agents-plant -animal -minerals 2.syntetic -coal tar
1. Natural Colouring Agents: • Plants: • Many plants contain colouring agents which may be extracted. and used as colorant. • Some Examples are: a. Chlorophyll-green b. Annatto seeds-yellow to orange
Animal:- Cochineal: It is an alkaline solution of the soluble Colouring principles caraminic acid of cochineal insects preserved by the addition of.It is very dark purplish red liquid.Minerals: -Mineral colours are termed pigments. -They are used to colour lotions, cosmetics and other preparation for external application. -As they are toxic, their use for internal preparation is forbidden. Ex: Red ferric oxide Yellow Ferric Dioxide
2. Synthetic colouring agents • The synthetic colours are coal tar dyes, because many of them are produced from substance obtained from coal-tar. • The certified colours are classified into three groups: • Group I- F.D. and C. Colours used in foods, drugs and cosmetics. • Groups II- The D. and C. Colour used in drug and Cosmetics. • Group III- The External D. and C. Colour.
b. Flavouring agents • The use of flavour is actually a composite sensation of taste, touch, smell, sound and heat. • There are simply four types of tastes - Sweet - Sour - Salty - Bitter . Similarly there are seven basic odours like - Ethereal , camphoraceous ,Musky, Floral ,Pepperminty ,Pungent ,Putrid
Classification of flavouring agents Two Types: 1. Natural and 2. Synthetic 1. Natural a. Fruits (Sweet, Sur and Astringent) Citrus Fruits (Orange, Lemon) b . Seeds (Vanilla, Anise, Nutmeg) 2.synthetics Benzaldehyde - Bitter Almond, Cherry pits Decyl Aldehyde - Citrus Flavours (Orange) Cinnamic aldehyde - Cinnamon type
c. Sweetening agents • Sucrose • Sorbitol (Half Sweet than Sucrose) • Glycerin • Honey • Saccharin Sodium (300-550 times) • Cyclametaes (30 times sweeter than sucrose) • Aspartame
d.Viscosity control Used to increase palatability and pourability Examples of viscosity controlling agents are -PVP -cellulose derivatives e.General apperance depends on colour and clarity
4.STABILITY a. Chemical stability Ex- effect of amino acids on stability of aspirin in propylene glycol solutions. b. Physical stability Oral liquids are stable if it retains viscosity,colour,taste and odour throughout its shelf life
liquid dosage forms Monophasic (homogeneous solutions in which solute and solvent cannot be differentiated) Biphasic Emulsions suspensions External Internal Draughts Drops Linctus Syrups Elixirs mixtures Liquids for oral cavities Liquids appiled on body cavities Liquids appilied on skin Douches Enemas Ear drops Nasal drops Inhalants and eye drops Gargles Mouthwashes Throat paints Glycerites Throat spray Liniments Lotions collidions
ORAL MONOPHASIC DOSAGE FORM • ORAL MONOPHASIC DOSAGE FORM Draughts Drops Linctuses Syrups Elixirs Mixtures
A. Draughts • It is simple solution (mixture) which contains a single dose. • Each dose is sent in separate bottle.Total volume is 50 ml. • It is essential to be labelled with storage conditions on draughts. • It is given very early expiry date (48 hours). Examples: 1.Ipecacuanha emetic draughts-BPC (Treatment of poison) 2. Paraldehyde draughts- Oxidized to acetic acid and cause death Do not use, if the solution is discolored.
Classification of mixtures • Mixtures containing soluble substances Eg: Carminative mixtures • Mixtures containing diffusible solids Eg: Bismuth, magnesium carbonate • Mixtures containing in diffusible solids Eg: Salicylic acid, quinine salicylate • Mixtures containing precipitates forming liquid Eg: potassium iodide
D . SYRUPS: • “It is concentrated aqueous solution of sucrose mixed with solution of medicaments and others additives.” • Generally syrup is prepared by sucrose but is partly replaced by dextrose or other polyhydric alcohols to reduce crystallisation of sucrose or to increase solubility of medicaments and other additives. • Consists of 85% sugars • 2 types of syrups Non medicated syrup Medicated syrup
FORMULATION OF SYRUP • Sugar-85% • Anti microbial preservatives(0.1-0.2%) benzoic acid ,sodium benzoate • Flavorant • colorant Example- Active drug – 5ml Other drug solids -3ml Glycerin - 15ml Sucrose -25g Ethanol - 95%qs Purified water - 100ml
Function of Syrups • Sweetening agent • Good antioxidant • Preservatives • Demulcents and • soothing agent • EXAMPLES OF SYRUPS: Codeine phosphate syrup Squill syrup
Syrups are used for formulating Antibiotics Antitussives Antihistamines Vitamins Analgesic/antipyretic PREPARATION OF SYRUP – 1.Solution with heat: For non-volatile, thermostable drugs 2.Agitation without heat: For volatile, thermolabile drugs 3.Addition of medicating liquid to syrup: For liquid medicaments such as extracts, tinctures 4.Percolation:
E. ELIXIRS Elixirs are clear, pleasantly-flavoures, sweetened Hydro alcoholic liquid intended for oral use. 2 types of elixirs • Medicated elixir • Non medicated elixir
ADDITIVES 1.Chemical Stabilizers: pH Adjustment Sequestering agents- like EDTA 2.Colouring Agents: Amaranth Compound Tartrazine 3.Flavouring Agents: Lemon spirit ,Compound orange spirit 4.Sweetening Agents: Invert Syrup, Sodium Sachharin 5. preservatives: 20% Alcohol as vehicle Propylene glycol
Formulation of phenobarbital elixir phenobarbital - 4g orange oil - 0.25ml propylene glycol - 100ml alcohol - 200ml sorbitol solution - 600ml colour - qs purified water - 1000ml EXAMPLES- Chloral Elixir pediatric Paracetamol Elixir Ephedrine Elixir Phenobarbitone Elixir

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