Knowledge of Pharma

·          Describes regarding sampling times, storage conditions& specific test parameters for each dosage form. ·          The FDA & The expert working group of the ICH of technical requirements for the registration of pharmaceuticals for human use have published guidelines for conducting the actual studies. ·          ICH guideline as follow, o    Quality Guidelines “Q” (chemical and pharmaceutical QA) o    Safety Guidelines “S” (in vitro and in vivo pre-clinical studies) §   covering Carcinogenicity Testing, Genotoxicity Testing, §   Toxicokinetics and Pharmacokinetics ….. etc. o    Efficacy Guidelines “E” (clinical studies in human subject) §   Covering clinical safety, Dose Response Studies, Good  §   Clinical Practices, Clinical evaluation …. etc. o    Multidiscipl...

·          Definition: A substance which is added to a preparation to prevent bacterial growth and subsequent spoilage of the preparation. ·          Preservative describes those antimicrobial agents used to protect pharmaceutical preparations. ·          Microbes are growth in non-sterile formulation lead to chemical changes in formulation and spoilage of product hence preservatives are required. ·          Examples: ethanol, alcohol, chlorhexidine, benzoic acid, methyl parabens, ethyl parabens. ·          Antimicrobial preservatives: o    Emulsions contain water, which will support microbial growth. o    Microbes produce unpleasant odours, colour changes and gases and may affect the emulsifying agent, possibly causing breakdown of the emulsion. ...

They are as: Antioxidant, preservatives, coloring agents, flavoring agents, diluents, binder, Disintegrant, glidant, emulsifier, surfactant, suspending agents They must be not interfere with the pharmacological action. Classification of Adjuvants. T here are various types of excipients available in pharmaceutical formulation. They are, 1. Diluents. (Fillers/ bulking agents) 11. Colouring agents. 2. Binders. 12. Ointment base. 3. Disintegrating agents. 13. Solvent & Co-solvent. 4. Granulating agents. 14. Buffering Agents. 5. Lubricants. 15. Chelating Agents. 6. Glidants. 16. Viscosity imparting Agents. 7. Preservatives. 17. Surface Active Agents/ Surfactants. 8. Antioxidant. 18. Coating agents. 9. Flavouring agents. 19. Sorbents. 10. Sweeting agents 20. Humectants. Please visit on link page for detail study. If not available then I u...

Introduction: Chemically they are reducing agents. They oxidize themselves and prevent oxidation of API. A substance that inhibits oxidation is called antioxidants. The effectiveness of antioxidant can depend on the concentration used and pH of solution. Examples:  Ascorbic acid,  butylated hydroxy anisole (BHA),  butylated hydroxyl toluene (BHT) Oxidation is a chemical reaction involving the loss of electrons or an increase in oxidation state. Oxidation reactions can produce free radicals. In turn, these radicals can start chain reactions. When the chain reaction occurs in a cell, it can cause damage or death to the cell. Antioxidants terminate these chain reactions by removing free radical intermediates, and inhibit other oxidation reactions. The following are some of the qualities of an ideal anti-oxidant: It should be readily soluble or dispersible in the medium. It should be effective in low concentration. It should...

Definition: A polymer that are degradable in-vivo , either by enzymatically or non-enzymatically, to produce biocompatible or nontoxic by-products. Biodegradation: A natural process by which organic chemicals are converted to simpler compound through elemental cycles such as the carbon, nitrogen and Sulphur cycles. Microorganism plays a central role in the biodegradation process. Bio degradation occur in two steps: 1 st step From Fragmentation of the polymer into lower molecules: By abiotic reaction i.e. oxidation, photo degradation, hydrolysis. By biotic reaction i.e. degradation by microorganism. 2 nd step: Bio Assimilation of the polymer fragments Biodegradability of the polymer depends on Its origin & chemical structure & also environmental condition Biodegradable polymers are capable of being cleaved into biocompatible by-product through chemical or enzyme catalyzed hydrolysis Advantages of Biodegradable polymer: Provide constant controlled r...

Introduction: Rational of Natural Gum/products are, Biocompatibility, low toxicity, environmental friendliness and low price. Natural gums obtained from plants have diverse applications in drug delivery as a, Disintegrant, emulsifying agent, suspending agents and as binders. Useful in formulating immediate and sustained-release preparation. Gums are formed as a natural phenomenon of the plant in which internal plant tissues disintegrate through a process called gummosis. This in turn form cavities, which give out transformed carbohydrates called gums. N atural gums (gums obtained from plants) are hydrophilic carbohydrate polymers of high molecular weights. Generally composed of monosaccharide units joined by glucocidic bonds. They are generally insoluble in oils or organic solvents such as hydrocarbons, ether, or alcohols. Gums are either water soluble or absorb water and swell up or disperse in cold water to give a viscous solution or jelly. On hydrolysis t...