What are the main components of a tablet formulation?

Components of a tablet formulation:

A tablet formulation typically consists of the following main components:

  • Active Pharmaceutical Ingredient (API): The API is the primary drug or therapeutic substance responsible for the intended pharmacological effect. It is the active substance that treats the medical condition.
  • Excipients: Excipients are inactive substances present in the tablet that assist in the manufacturing process and overall performance of the tablet. They can serve various functions in the formulation.

Additional Information

The role of each component in tablet formulation is as follows:

Active Pharmaceutical Ingredient (API)

  • The API is the main therapeutic agent in the tablet, responsible for producing the desired medical effect in the patient’s body.
  • It is essential for the API to be of high purity and quality to ensure the tablet’s efficacy and safety.
  • APIs can be in various forms, such as powders, granules, or crystalline substances, depending on their solubility and stability.
Pharma Tip:  Explain the concept of tablet weight variation and its acceptable limits.

Excipients

  • Binders: Binders are substances that promote cohesive properties in the tablet, holding the ingredients together and maintaining the tablet’s shape during compression and handling.
  • Diluents (Fillers): Diluents add bulk to the tablet and ensure that the API is distributed uniformly throughout the formulation. They help achieve the desired tablet size and weight.
  • Disintegrants: Disintegrants facilitate the breakup of the tablet after ingestion, promoting its dissolution and release of the API in the gastrointestinal tract for absorption. They help improve the tablet’s bioavailability.
  • Lubricants: Lubricants reduce friction between the tablet and the punches of the tablet press during compression. This prevents sticking and ensures a smooth tablet ejection from the machine.
  • Glidants: Glidants improve the flow properties of the tablet mixture, allowing for more uniform and consistent tablet compression.
  • Colorants: Colorants are added to tablets for visual identification and to make them more appealing to patients. They do not contribute to the tablet’s therapeutic effect.
  • Flavoring Agents: Flavoring agents may be included in chewable tablets or orally disintegrating tablets to enhance the taste and patient acceptability.
  • Sweeteners: Sweeteners can be added to mask the bitter taste of certain APIs, making the tablet more palatable for patients.
  • Coatings: Coatings may be applied to tablets for various purposes, such as improving appearance, taste masking, and modifying drug release profiles (e.g., enteric coatings).