Pharmaceutical Product Development Unit 3 Complete Notes

Tablet and capsule excipients play a critical role in the development and formulation of pharmaceutical products. Excipients are inactive ingredients that are added to medications to enhance the stability, bioavailability, and overall performance of the active pharmaceutical ingredient (API), as well as to improve the manufacturing process. In this blog post, we will delve into the different types of excipients commonly used in tablet and capsule formulations, their functions, and their impact on the final product.

1. Binders:

Binders are excipients used to hold the tablet together and provide cohesion to the powders or granules during compression. They act as a glue, ensuring that the tablet remains intact even after repeated handling and storage. Common binders include microcrystalline cellulose, polyvinylpyrrolidone (PVP), and hydroxypropyl methylcellulose (HPMC).

2. Diluents:

Diluents, also known as fillers, are used to increase the bulk of the tablet or capsule formulation. They ensure that the correct dosage of API can be effectively compressed into a tablet or filled into a capsule. Commonly used diluents include lactose, mannitol, and microcrystalline cellulose.

3. Disintegrants:

Disintegrants facilitate the breakup and dissolution of a tablet or capsule in the gastrointestinal tract, thus enhancing drug release and absorption. They help to ensure that the medication is rapidly and completely dissolved, enabling the API to be readily absorbed into the bloodstream. Examples of disintegrants include croscarmellose sodium, crospovidone, and sodium starch glycolate.

4. Lubricants:

Lubricants are added to tablet and capsule formulations to reduce friction and prevent sticking during the manufacturing process. They facilitate the flow of powders, improve tablet ejection from the die, and prevent agglomeration. Common lubricants include magnesium stearate, stearic acid, and sodium stearyl fumarate.

5. Glidants:

Glidants, also called flow agents, improve the flowability of powders during tablet compression or capsule filling. They reduce friction between particles, resulting in better powder flow and uniformity. Talc, colloidal silicon dioxide, and magnesium oxide are commonly used glidants.

6. Dispersants:

Dispersants aid in the uniform distribution of API within the tablet or capsule formulation. They ensure that the active ingredient is evenly mixed with other excipients, leading to consistent drug content in each dosage unit. Polysorbate 80, sodium lauryl sulfate, and polyvinyl alcohol are commonly employed dispersants.

7. Coloring agents:

Coloring agents are optional excipients added to tablets or capsules for aesthetic purposes or to differentiate different strengths or formulations of the same medication. FDA-approved dyes and pigments, such as titanium dioxide and FD&C dyes, are used as coloring agents in pharmaceutical products.

It is important to note that