Dosage form design


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Dosage form design

  1. 1. Pharmaceutical and Formulation Considerations
  2. 2. What is Pharmaceutical technology? • Pharmaceutical Technology is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) into a medication to be used safely and effectively by patients. • It is also called the science of dosage form design. • It deals with the formulation of a pure drug substance into a dosage form
  3. 3. Drug and medicine • Medicine is actually the drug delivery system • That is, they are means of introducing drugs to the body in safe, efficacious, reproducible and convenient ways • Medicines are rarely drugs alone, but requires excipients or additives or pharmaceutical ingredients to be formulated into dosage forms
  4. 4. Different Dosage Forms
  5. 5. Pharmaceutical ingredients or excipients • The non-medicinal agents that are given as parts of a formulation in combination with a drug substance to produce a final dosage form and serve varied and specialized pharmaceutical functions are known as pharmaceutical ingredients or excipients. • Examples: For solutions- solvents, flavors, sweeteners, colorants, preservatives, stabilizers etc. For tablets- diluents or fillers, binders, lubricants, disintegrating agents etc.
  6. 6. What are the purposes of formulating different types of dosage forms? • In order to provide the safe and appropriate dose of a drug to the patient, drug substances are formulated in a dosage forms • Selective use of different excipients produces dosage forms of various types • Besides providing the safe and convenient delivery of accurate dosage, there are different purposes for which different dosage forms are designed. These are : 1) To protect the drug substance from the destructive influences of atmospheric oxygen or humidity (coated tablets, sealed ampuls)
  7. 7. Sealed ampoules and coated tablets
  8. 8. The purposes … 2) To protect the drug substance from the destructive influences of gastric acid after oral administration ( enteric coated tablets)
  9. 9. The purposes … 3) To conceal the bitter, salty or offensive taste or odor of a drug substance (capsules, coated tablets, flavored syrups) 4) To provide liquid preparations of substances that are either insoluble or unstable in the desired vehicle ( suspensions)
  10. 10. The purposes … 5) To provide clear liquid dosage forms of substances ( syrups, solution) 6) To provide rate-controlled drug action ( various controlled release tablets, capsules and suspensions) 7) To provide optimal drug action from topical administration sites ( ointments, creams, transdermal patches and ophthalmic ear & nasal preparations)
  11. 11. The purposes … 8) To provide for insertion of a drug into one of body’s orifices ( rectal or vaginal suppositories)
  12. 12. The purposes … 9) To provide for placement of drugs directly in the bloodstream or body tissues (injections) 10) To provide for optimal drug action through inhalation therapy ( inhalants and inhalation aerosols)
  13. 13. Major considerations in dosage form design • Three major things should be considered before designing a dosage form : -The physicochemical considerations - The biochemical considerations - Determination of the desired product type and establishment of a framework for product development
  14. 14. Major considerations …. • Then, various initial formulations of the product are developed and examined for desired features (e.g., drug release profile, bioavailability, clinical effectiveness etc.) • The formulation that best meets the goals for the product is selected as “master formula”.
  15. 15. Major considerations …. • Then a pilot batch and subsequently large scale production is carried on • Each of the subsequently prepared batch of the product must meet the specifications established in the master formula • Most commonly a manufacturer prepares a drug substance in several dosage forms and strengths for the efficacious and convenient treatment of disease
  16. 16. Major considerations…. • Some therapeutic matters are also considered before formulating different kinds of dosage forms like- nature of illness ( whether emergency or not) - manner of treatment ( whether local or systemic action) - the age and anticipated condition of the patient ( for infants and children liquid preparation is preferred, for young patient with cough & vomiting injections or suppositories are preferred)
  17. 17. Major considerations…. - in case of swallowing problem, chewable tablet or capsules may be prepared - to reduce the frequency of administration, sustained release or extended released form is preferred - Thus the therapeutic considerations, in turn helps to decide the suitable dosage form, the appropriate route of administration, suitable duration and dose frequency if the drug in question