Pharmaceutical additives for liquid dosage form

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pharmaceutical additives used in liquid dosage form

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Pharmaceutical Additives Used for development of liquid oral :

Pharmaceutical Additives Used for development of liquid oral 1 Presented By, Chetan M. Jain First Year M.Pharm (Quality Assurance) Government College of Pharmacy,Amaravati.

Drug:

Drug API A substance which has a therapeutic effect when administered. Drug is not administered as it is. CHETAN JAIN 2

Pharmaceutical Additives:

Pharmaceutical Additives Substances which are of little or no therapeutic value, but which are added to the formulation in order to, Help the production Maintain physicochemical stability Improve patient acceptability To improve the functioning of the dosage form as a DDS 3 CHETAN JAIN Pharmaceutical aids, necessities, adjuvants or excipients .

Ideal Properties:

Ideal Properties Physiologically inert Physiologically stable Do not impart any undesired taste, colour and odour Non-toxic, non-irritant and non-sensitizing. Effective in low conc. Free from microorganisms Not interfere with bioavailability of the drug. Accepted by regulatory authorities. 4 CHETAN JAIN

Pharmaceutical Additives used in Liquid Dosage Form:

Pharmaceutical Additives used in Liquid Dosage Form 5 Vehicles Surfactants Hydrocolloids Antioxidants Complexing agents Preservatives Colouring agents Flavouring agents Sweetening agents Buffers Tonicity adjusters Liquid Dosage Forms CHETAN JAIN

Vehicles :

Vehicles Medium in which ingredients of a formulation are dissolve, suspended or dispersed. Pharmaceutical vehicles can be classified as under 6 Aqueous vehicles: Water, Aromatic Water, Alcohol,glycerin, Propylene Glycol. Oily vehicles: Vegetable oils, mineral oils, organic oily bases or emulsified bases. CHETAN JAIN

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Water Cosolvency CHETAN JAIN 7 Lack of toxicity, Physiological compatibility,and its ability to dissolve a wide range of materials. Potable water Purified water BP. Phenobarbitone, Aminophylline- Carbon dioxide. Apomorphine and Ergotamine - Oxidation Water miscible solvents Water/ethanol blend, sorbitol , glycerol, propylene glycol and syrup. Propylene glycol and water for Co-trimoxazole. Paracetamol elixer- Alcohol,propylene glycol and syrup.

Surfactants:

Surfactants Solubilising agents Wetting agent Emulsifying agents Antifoaming agents 8 HLB value- 15 to18. eg. Polysorbate 80. HLB value 8 to 10 Tweens, spans ,SLS o/w emulsifiers- 8 to 18 w/o emulsifiers-3 to 6 Glycol, glycerol esters, cetrimide. HLB- 1.5 to 3 Castor oil, fatty acids. CHETAN JAIN

Anti-oxidants:

Anti-oxidants Effective when used in their soluble form. Conc. 0.01 to 1% True Antioxidants Reducing agent Synergist antioxidants 9 Act by suppressing the formation of free radical. Eg. Alphatocopherol, BHA, BHT, Methyl gallate. These get preferentially oxidised over the drug. Eg. Sodium sulphide, Sodium bisulphide,sodium metabisulphide. Used in combination with above. Act by regeneration of antioxidant radical or by chelating metals. Eg. EDTA, Ascorbic acid, citric acid. . CHETAN JAIN

Hydrocolloids:

Hydrocolloids High mol. Wt. subs Produce highly viscous soln , suspension or gels. Natural : acacia, tragacanth , agar. Semi-synthetic : methyl cellulose, sod.CMC, HEC. Synthetic : carbopols . CHETAN JAIN 10

Preservatives :

Preservatives Stop the multiplication of microbes. Mainly included for fungistatic action. For oral solution: 11 Benzoic acid (0.1-0.2%) Sodium benzoate(0.1-0.2%) Alcohol (15-20%) Glycerin (45%) Methyl paraben and propyl paraben (10:1) CHETAN JAIN

Colouring agents :

Colouring agents To give aesthetic appeal and impart pleasing appearance. Mask discoloured , degraded ingredients and to maintain appearance during shelp life. For identification. Synthetic colours Natural Colours : 12 Colours for FD&C Colours for D&C FD&C Red no.3(Erythrosine) FD&C Yellow no.5(Tartrazine) D&C Blue no.5(indigo) D&C Red no.22(Eosine) D&C Yellow no 7 (fluorescein) Vegetable colours: Chlorophyll, carotene. Animal colour: Cochineal. Mineral Colours: Titanium dioxide, ferric oxides. CHETAN JAIN

Flavouring agents :

Flavouring agents To mask unpleasant smell. Vitamins with cherry, Strawbery or raspberry flavour . Paediatric drops fruity flavour . Volatile oils including cinnamon, clove, lemon, orange and peppermint flavour which activate olfactory cells. Natural Sources: Pine-apple, Cardamom, ginger. Volatile oils- Clove, lemon, orange, rose. Synthetic Chemicals: Alcohol, aldehydes , fatty acids, esters. 13 CHETAN JAIN

Sweetening agents:

Sweetening agents Are natural or synthetic agents. Sugars : Polyhydric alcohols: Artificial : 14 Sucrose, fructose, glucose, syrup. Sorbitol, Mannitol, glycerin. Saccharin, Aspartame CHETAN JAIN

Buffers :

Buffers Resists any change in pH when acid or base is added. To encounter stability problem. pH -7.4 to 8.4. Eg . Monobasic sod. Acetate, sod. Citrate, pot.phosphate , pot. Metaphosphates . 15 CHETAN JAIN

References:

References Pharmaceutics “The Science of Dosage Form Design” By M.E.Aulton , 1 st Edition (1996) P.No.254-290. The Theory And Practice of Industrial Pharmacy By Leon Lachman and Herbert Lieberaman ., Published By Varghes Publishing House, 3 rd Edition, P.No429,457. Modern Dispensing Pharmacy By Atmaram Pawar and R.S. Gaud, Career Publication,3 rd Edition(2009) P.No . 134-139. Introduction To Pharmaceutics II By A.K. Gupta And S.S. Bajaj, CBS Publishers, 4 th Edition, P.No.138-148. www.google.com. CHETAN JAIN 16

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