dosage

• Dosage Form


  Drug products/preparations containing active pharmaceutical ingredient (API) and excipients/additives/adjuncts
• Drug Delivery System


  Drug products that allow the uniform release and targeting of drugs into the body
• Drug


  An agent intended for use in diagnosis, cure, treatment, mitigation or prophylaxis in man and other animals - affects the structure or any function of the body
• Excipients (adjuncts or additives)

  Nontherapeutic ingredients which improve the physical characteristics and efficacy of a drug in a dosage form. Role: make drugs more appealing and efficacious. Use: solubilize, suspend, emulsify, dilute, stabilize, preservatives, color, flavor, etc.
• Cosmetics


  Any substance/preparation intended to be placed in contact with external parts of human body or with teeth and mucous membranes of oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, correcting body odors, changing their appearance, protecting them and/or keeping them in good condition
• Food Supplement


  Processed food products that help supplement the diet, may contain dietary ingredients such as vitamins, minerals, herbs, amino acids, and other dietary substances, take various forms including liquids, capsules, powders, etc., except parenteral
• Compounding


  The process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient
• Local effects


  Felt in general area of administration, common route: topical
• Systemic effects


  Occur in tissues distant from the site of contact between the body and the drug, drug must enter the bloodstream, common route: oral and parenteral
• Powders


  Mixtures of finely divided drugs and/or chemicals in a dry form which may be intended for internal or external use
• Powders


  • Advantages: rapid dispersion of ingredients, flexibility in compounding, good chemical stability. Disadvantages: inaccuracy of dose, not suitable for unpleasant-tasting, deliquescent and hygroscopic drugs
• USP Classification of Powders by Sieve Number

  • Very coarse (no. 8)
  • Coarse (no. 20)
  • Moderately coarse (no. 40)
  • Fine (no. 60)
  • Very fine (no. 80)
• Compounding of Powders


  1. Comminution: Trituration, Levigation, Pulverization by Intervention

  2. Mixing/Blending: Trituration, Spatulation, Sifting, Geometric Dilution, Tumbling
• Types of Powders


  • Bulk Powders: Oral Powders, Dentifrices, Dusting Powders, Douche Powders, Insufflations, Trituration
  • Divided Powders/Chartulae
• Types of Powder Paper

  • White Bond Paper
  • Vegetable Parchment
  • Glassine Paper
  • Waxed Paper
• Granules


  Dry aggregates of powder particles, normal sieve no. 4 to 12, tablet formulation: sieve no. 12 to 20
• Granules


  • Advantages over powders: flow well, less tendency to cake or harden, more stable to humidity, more easily wetted by liquids
• Compounding of Granules


  Wet Granulation, Dry Granulation, Effervescent Granules
• Tablets


  Solid dosage forms which are prepared mainly by compression or molding
• Tablets


  • Advantages: uniform content, less manufacturing cost, easy to package and ship, simple to identify, most stable of all oral dosage form, tamperproof. Disadvantages: some drugs resist compression, some drugs require encapsulation prior to compression
• Types of Tablets for Oral Ingestion

  • Compressed Tablets, Multiple Compressed Tablets, Coated Tablets
• Types of Tablets Used in the Oral Cavity

  • Chewable Tablets, Rapidly/Orally Disintegrating Tablets, Buccal Tablets, Sublingual Tablets, Lozenges
• Types of Tablets Used to Prepare Solutions

  • Effervescent Tablets, Compounding/Dispensing Tablets, Hypodermic Tablets, Molded Tablets/Tablet Triturates
• Capsules


  Solid dosage forms in which the drug is enclosed within either a hard or soft, soluble shell, usually made of gelatin
• Types of Capsules


  • Hard Gelatin Capsules, Soft Gelatin Capsules
• Oral Modified-Release Solid Dosage Forms


  Drug release features are based on time, course and locations
• Oral Modified-Release Solid Dosage Forms

  • Advantages: economic savings, avoid patient compliance problems, reduce fluctuation in drug level, minimize or eliminate side effects
• Mechanism of Immediate-Release Formulation

  Rapid disintegration and dissolution of the drug
• Types of Modified-Release Dosage Forms

  • Extended-Release, Delayed-Release, Repeat Actions, Targeted Release
• Extended-Release


  Provides a prompt desired effect followed by a gradual release of remaining amount, problem: dose dumping
• Controlled Release


  Zero order drug release
• Sustained Release


  First order drug release
• Delayed-Release


  Drug release is other than the time of prompt administration, e.g. enteric-coated
• Repeat Actions


  Contains 2 single doses of a medication, 1st dose immediate, 2nd dose delayed
• Targeted Release


  Drug release is isolated in a specific body region/tissue to optimize absorption and action, e.g. colonic tablets, gastro retentive tablets
• Types of Modified-Release Dosage Forms

  • Extended-Release
  • Delayed-Release
  • Repeat Actions
  • Targeted Release
• Extended-Release


  Provides a prompt desired effect followed by a gradual release of remaining amount
• Extended-Release


  • Problem: dose dumping
• Types of Extended-Release


  • Controlled Release – zero order
  • Sustained Release – first order
• Delayed-Release


  Drug release is other than the time of prompt administration