Dosage from

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Dosage from

  1. 1. Presented By Dileep Singh Baghel Asst. Professor, LSPS, LFAMS Lovely Professional University, Punjab 1
  2. 2. Pharmaceutical Industry Customers Pharmaceutical Industry Medicines Main Patient Return Documents Regulatory Agencies
  3. 3. From Molecule to Patient Therapeutic Target Discovery/ Literature serve Patient Distribution Research and Development Final Dosage form Approval Manufacture
  4. 4. By which drug molecules are delivered to sites of action within the body is c/a Dosage form.
  5. 5. Mechanism for safe and convenient delivery of accurate dosage. Protection of drug from atmosphere or increasing self life of drugs. Masking taste and odour. Delivering the drugs within body tissues. Sustained release medication. Controlled release medication. Optimal drug action or Improving ADME of the drugs.
  6. 6. Classification of dosage forms : They are classified according to: Route of administration Oral Topical Rectal Parenteral Vaginal Inhaled Opthalmic Physical form Solid Semisolid Liquid Gaseous
  7. 7. Pharmaceutics Active Ph. Ingredients Pharmacokinetics Pharmacodynamic Adverse Effects Business & Economics Governmental Regulation Therapeutic usage/ Equivalence Pharmaceutical Equivalence Bioequivalence 7
  8. 8. Pharmaceutics is the science of dosage form design. There are many chemicals with known pharmacological properties but in a raw form it is worth less for patient. Pharmaceutics deals with the formulation of a pure drug substance into a dosage form. 8
  9. 9. Drugs or Active Ph. Ingredient ACTIVE PHARMACEUTICAL INGREDIENT PROVIDES THE THERAPEUTIC EFFECT ACTIVE PHARMACEUTICAL INGREDIENTS = DRUG SUBSTANCES
  10. 10. API + EXCIPIENTS ACTIVE INERT DOSAGE FORM
  11. 11. Effectiveness Safety Reliability Stability Physical Chemical Microbiological
  12. 12. Pharmaceutical elegance Appearance Organoleptic properties Convenience Ease of use Dosing frequency Consumer acceptance
  13. 13. Excipients may be added to protect the drug Antioxidants Preservatives Chelating agents Buffering agents
  14. 14. Therapeutic usage Determining which diseases are approved to be treated by a drug Discovering how a drug works to achieve its therapeutic activity Finding the recommended dosage and route administration of a drug Learning how a drug is absorbed, distributed, metabolized, and excreted
  15. 15. List of possible unpleasant or dangerous secondary effects other than the desired effects Causes of ADRs Interactions Drug/Drug Drug/Food Drug/Herb Toxic potential
  16. 16. Business & Economics Drug prices Drug sales Drug companies Drug Manufacturers Drug Stores Most commonly prescribed drugs
  17. 17. Government regulation Drug approval process. Identifying which countries have approved the usage of a specific drug. The restriction or prohibition of the usage of specific drugs (controlled substances) Policies and codes regulating the manufacture, distribution, and sales of pharmaceutical agents
  18. 18.  Pharmaceutical Equivalence  Same active ingredient.  Same strength.  Same dosage form and route of administration.  Comparable labeling  Meet compendial or other standards of identity, strength, quality, purity and potency  Bioequivalence  In vivo measurement of active moiety (moieties) in biologic fluid (blood/urine)  In vivo pharmacodynamic comparison  In vivo clinical comparison  In vitro comparison  Therapeutic Equivalence
  19. 19. Standardization & Quality Evaluation • Colour • Odour • Taste • Texture • Fracture •Shape • Quantitative •External Macroscopic •Marking Microscopic QUALITY EVALUATION OF HERBAL DRUGS Microbial Contamination BI OL OG IC AL • Other specific activities •Qualitative Antagonistic • Bacterial • Fungal • Powder Studies • Moist. Cont. • Extrac. Values • Ash Values • Fluores. Analy. AL EMIC CH • Toxicological • Pharmacological • SEM Studies BOTA N IC A L PHYSICAL PHYSICAL C TI P LE NO A G R O • Qualitative HPTLC GLC HPLC • Quantitative • Chromatography • Heavy metal • Pesticide residue • Mycotoxin HPTLC Finger printing Sec. Metabolites DNA Finger printing
  20. 20. Thank You

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