Pharmaceutical Reference & Dosage Form PT2

• How are drug substances typically administered?

  As part of a formulation that includes excipients
• What is the active ingredient in each Paracetamol tablet?

  Paracetamol 500 mg
• What are the inactive ingredients in a Paracetamol tablet?

  • Potato starch
  • Pre-gelatinized maize starch
  • Talc
  • Colloidal silica
  • Magnesium stearate (E572)
• What is an Active Pharmaceutical Ingredient (API)?

  A chemical compound intended for diagnosis, treatment, or prevention of diseases

  
• What is an excipient?

  An inactive substance that acts as a carrier or medium for a drug
• What is a dosage form?

  A combination of drug substances and excipients formulated for effective administration
• What are the key goals of dosage forms?

  1. Ensure intended therapeutic effect
  2. Administer through appropriate route with minimal dosage
  3. Achieve rapid onset and optimal duration of action
  4. Ensure efficient elimination without residual effects
  5. Maintain elegance and stability under various conditions
• What biopharmaceutical aspect influences the route of administration?

  The drug's pharmacokinetics (ADME: absorption, distribution, metabolism, elimination)
• What determines the appropriate dosage form and route of administration?

  The clinical condition or disease
• Why is careful evaluation of a drug's properties essential in dosage form development?

  To create a stable and effective dosage form
• What are the key factors in dosage form development?

  1. Safety: Deliver the drug without harm
  2. Efficacy: Achieve desired therapeutic effect
  3. Stability: Remain effective throughout shelf life
  4. Patient Compliance: Ease of following treatment regimen
• What are the stages in dosage form development?

  1. Pre-formulation: Understand drug properties
  2. Formulation: Develop dosage form with excipients
  3. Pre-Clinical Testing: Evaluate safety and activity
  4. Clinical Trials: Test in humans for safety and efficacy
  5. Approval: Obtain regulatory approval
  6. Post-Market Monitoring: Ongoing safety surveillance
• What is the purpose of pre-formulation in dosage form development?

  To understand the physical and chemical properties of the drug
• What is the role of clinical trials in dosage form development?

  To test the dosage form in humans for safety and efficacy
• What is the purpose of FDA Post-Market Safety Monitoring?

  To identify long-term effects or rare adverse reactions
• What are the types of excipients used in drug formulations?

  • Colouring agents
  • Flavouring agents
  • Preservatives
  • Antioxidants
  • Vehicles
  • Suspending agents
  • Emulsifying agents
• How are dosage forms classified?

  1. Route of administration:

  • Oral
  • Topical
  • Parenteral
  • Ophthalmic, Otic, Nasal
  • Inhalation
  • Rectal
  • Vaginal

  1. Physical form:

  • Solid
  • Semisolid
  • Liquid
  • Gaseous

  
• What are the advantages of tablets as a dosage form?

  Easy to administer, stable, precise dosage, cost-effective
• What are the basic components of tablets?

  Drug (active ingredient) and excipients (inactive ingredients)
• What are the types of tablets?

  1. Uncoated / immediate-release tablets
  2. Coated tablets (sugar-coated, film-coated, enteric-coated)
  3. Modified release tablets (SR, ER, delayed release, controlled release)
• What is an effervescent tablet?

  An uncoated tablet designed to dissolve in water before administration
• What are chewable tablets designed for?

  To be chewed before swallowing
• What are sublingual and buccal tablets used for?

  To dissolve under the tongue or between the gum and cheek for rapid action
• What are capsules?

  Solid dosage forms where drugs are enclosed in a gelatin container
• What are the two main types of capsules?

  Hard gelatin capsules and soft gelatin capsules
• What are lozenges or troches?

  Hard, disk-shaped dosage forms that dissolve slowly in the mouth
• What are pastilles?

  Solid dosage forms that dissolve slowly in the mouth
• What are granules?

  Coarse particles formed by wetting, drying, and grinding powders
• What are powders (oral)?

  Finely ground dry particles that are reconstituted in liquid before use
• What is a syrup?

  A concentrated sugar solution that may or may not contain medication
• What is an elixir?

  A clear, sweetened solution with dissolved medication in water and alcohol
• What is a linctus?

  A viscous liquid for cough relief containing syrup or glycerol
• What is an emulsion?

  A mixture of two immiscible liquids (oil and water) stabilized by an emulsifying agent
• What is a suspension?

  A liquid with small solid particles suspended in the base solution
• Why does a suspension require shaking before use?

  To redistribute particles that may have settled to the bottom
• What are oral drops?

  Small-volume liquids for precise dosing
• What is a gargle/oral rinse?

  Aqueous solutions for throat treatment that should not be swallowed
• What is mouthwash used for?

  To refresh or disinfect the mouth, typically for cosmetic use
• What is a cream in topical dosage forms?

  A semisolid emulsion that may contain medication
• What is a lotion?

  A thinner topical form containing more water