PART 3 module 2

• ❖ “Significant change” for a drug substance is defined as failure to meet its specification.
• Quality control - is an essential operation in the production of drugs, a procedure or set of procedures designed to ensure the output of uniform batches of drugs conforms to the established specifications.
• There are different types of dosage forms:

  1. Solid dosage form
  2. Liquid dosage form
  3. Semi-solid dosage form
  4. Gas dosage form.
• Dosage form - means a physical form by which drug molecules are delivered into the site of action
• solid dosage forms - are the most commonly used dosage form because of the stability and ease of mass production.
• solid dosage forms - are solid in nature which contain one or more drugs for therapeutic effects and excipients like Binders, Sweeteners, coloring agents, etc.
• Example of solid dosage form:

  Tablets, capsules, granules, sachets, powders, dry powder inhalers, and chewable.
• Advantages of solid dosage form:

  • More stable than other dosage forms.

  * Easy to handle.

  • More accurate of the dosage form.

  • No preservation required.
• Disadvantages of solid dosage form:

  • Expensive Machines.

  • Tough to swallow for kids and patients in sleeping condition.
• Types of solid dosage form

  We can divide solid dosage form into 2 parts according to the amount of the dose-

  1. Unit Dose

  • Tablets

  • Capsules

  • Granules

  • Sachets

  • Lozenges

  • Pills

  • Dry powder inhaler • Chewables

  2. Bulk Dose

  • Powder (External and Internal)
• Tablets are compressed solid dosage form contain therapeutic active ingredients and excipients.
• Capsules are solid dosage forms where the therapeutic active ingredient granules are enclosed within a hard or soft soluble shell.
• Granules are solid dosage forms made up of agglomeration of smaller particles of powders.
• Sachets are solid dosage forms containing therapeutic ingredients. Small size spherical granules packed into a small bag or pouch packet.
• Lozenges are the solid dosage form that dissolves slowly into the mouth. Lozenges contain a drug along with flavoring and sweetening agents.
• Excipients are those materials which are used in every dosage form, doesn't have any therapeutic effects or side effects.
• Binding Agents: The role of binders or binding agent is to make the plasticity in the tablet formulation.
• Binding agents - helps to maintain the inter-particle bonding strength and to achieve mechanical strength and sometimes for the drug release properties.
• Binding agents are:

  • Natural polymers: Starch, gelatin, acacia, tragacanth.

  • Synthetic polymer: Hydroxypropyl methylcellulose (HPMC), Methyl cellulose, Ethylcellulose, Polyethylene glycol (PEG).

  • Sugar: Glucose, Sucrose, Sorbitol
• Coating Agents - This is used in tablet preparation.
• coating agent is protecting the drug from environmental moisture, light, or the acidic environment of the stomach and it also masks the bitter taste of many drugs.
• Coating Agents:

  • Suger Coating

  • Film Coating

  • Enteric coating
• Preservatives are basically used to protect the formulation from the attack of microorganisms. Such as bacterial growth, fungus growth, etc.
• Examples of preservative: Phenol, parabens, aryl and alkyl acids, etc.
• Coloring agents are used to giving an attractive outlook for the patients.
• Example of natural colors: Turmeric, Titanium Dioxide, etc.

  Examples of Synthetic colors: Erythrosine, Tartrazine, etc.
• Sweetening agents are used in basically chewable tablets.
• Sweeting agents - is to cover up the unpleasant taste of the tablet or any pharmaceutical formulation.
• Example of sweetening agents: Sucrose, fructose, etc.
• Semisolids dosage form - constitute a significant proportion of pharmaceutical dosage forms.
• Semi-solid dosage form - serve as carriers for drugs that are topically delivered by way of the skin, cornea, rectal tissue, nasal mucosa, vagina, buccal tissue, urethral membrane, and external ear lining.