Coloring, Flavoring, and Sweetening Agents in Pharmaceuticals

Flavoring Agents in Chewable Tablets

• Maximum allowable amount of flavoring agents in chewable tablets is typically regulated, but specific limits may vary by region.

Sweetening Agents

• Aspartame is a sweetening agent that is sweeter than sucrose, known for causing a bitter aftertaste and considered to be potentially carcinogenic.

Role of Adsorbents

• Adsorbents are added in tablet production to absorb moisture, preventing degradation and ensuring stability of the final product.

Dissolution-Retarding Polymers

• Hydroxypropyl methylcellulose (HPMC) is commonly used to retard dissolution in tablets, controlling the release rate of the active ingredient.

Wetting Agents in Poorly Soluble Drugs

• Wetting agents aid solubility and improve the dissolution of poorly soluble drugs in tablet formulations.

Disadvantage of Sucrose

• Sucrose can lead to dental caries and may cause fluctuations in blood glucose levels, making it less desirable for some formulations.

First Step in Wet Granulation

• The initial step involves the mixing of active ingredients with a binder to form a wet mass.

Tablet Production without Granulation

• The direct compression method enables tablet production without the need for initial granulation, simplifying the process.

Purpose of Sodium Carboxymethylcellulose

• Sodium carboxymethylcellulose serves as a binder and disintegrant in direct compression tablet production, enhancing tablet integrity and dissolution.

Disintegrant Addition in Dry Granulation

• In the dry granulation process, disintegrants are typically added after the granules are formed, ensuring effective decomposition of the tablet upon ingestion.

Method for Moisture or Thermosensitive Ingredients

• The direct compression process is the preferred method for tablet production when dealing with moisture-sensitive or thermosensitive ingredients, as it avoids heat and excessive moisture exposure.

Flowability and Cohesion in Direct Compression

• Microcrystalline cellulose is commonly included to enhance flowability and cohesive properties of the powder mixture for direct compression tablet production.

Advantage of Direct Compression

• Direct compression offers a faster manufacturing process and reduces the need for additional processing steps, making it more efficient and cost-effective.

This quiz covers the identification and use of coloring agents in off-color drugs, the production of elegant products, and the characteristics of flavoring and sweetening agents in pharmaceuticals. Topics also include the disadvantages and safety considerations of various sweetening agents.