GRANULATION PROCESS IN PHARMACEUTICAL MANUFACTURING:

Granulation is required to improve the flow of powder mixtures and mechanical properties of Tablet. Granulation is the act or process in which primary powder particles are made to adhere to form larger, multiparticle entities called granules. It is the process of collecting particles together by creating bonds between them. Bonds are formed by compression … Read more

Sifting Process in Pharmaceutical Manufacturing:

Sifting is a screening process to exclude foreign matter / particles (if any) and particles beyond the required size. Sifting is carried out by allowing particles to pass through specified mesh under the influence of vibration and gyration. The mesh (sieve) size is specified as the number of pores on 1 inch. Example 100 mesh … Read more

Unit Operations during manufacture of Tablets:

Unit Operations: The manufacture of Tablets is a complex multi-stage process under which the starting materials change their physical characteristics a number of times before the final dosage form is produced. Numerous unit operations are involved in making Tablets including sifting, mixing, granulation, drying, sizing, blending, lubrication, compression and coating. DISPENSING OF RAW MATERIALS (API … Read more

DETERMINATION OF CAPSULE SIZE FOR FORMULATION:

Formulation of Capsules includes active ingredient and excipients (Fillers, Disintegrant and Glidant / Lubricant). Particle size distribution (PSD) and bulk density (BD/TD) of API/Excipients is important parameter in the selection of capsule size. Determination of appropriate capsule size for formulation: Blend with BD 0.4 g/cc and fill weight 200 mg to filled D= M/V     0.4 … Read more

Solid Dosage Form – Capsules:

CAPSULES: Capsules are solid dosage forms in which medicinal agents are enclosed within hard or soft soluble shell of gelatin. The capsules are regarded as container drug delivery system that provides a tasteless/odorless dosage form without need for secondary coating step. Advantages of Capsules: Disadvantages of Capsules: TYPES OF CAPSULES: Capsules can be broadly classified … Read more

Solid Dosage Form – Tablets

TABLETS: Tablets are the solid pharmaceutical dosage forms containing drug substances with or without suitable diluents and prepared either by compression or molding methods. Advantages of Tablets: Disadvantages of Tablets: EXCIPIENTS USED IN THE MANUFACTURE OF TABLETS: In addition to the active ingredient, solid dosage forms will also contain a range of substances called excipients. … Read more

PHARMACEUTICAL DOSAGE FORMS

Pharmaceutical Dosage Forms: Dosage forms are the means by which drug molecules are delivered to sites of action within the body. The requirement for dosage forms: Classification of pharmaceutical dosage forms: Dosage forms are classified according to route of administration and physical forms. ORAL DOSAGE FORMS: SOLID DOSAGE FORMS TABLET: A tablet is a hard, … Read more

Handling of Product quality complaints

Handling of Product quality complaints in pharmaceutical Industry: Product quality complaints are also known as Market complaints, customer complaints, Technical complaints, quality complaints, etc. What is complaint: A written or verbal communication received from Consumer, end-user, Client, Caregiver, Pharmacy, Regulatory authority, government agency, Qualified Person, Responsible Pharmacist, Retailer, Distributor, field staff, contract giver,  beneficiary, purchaser … Read more

USFDA INSPECTION SYSTEMS

Inspection: The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm’s compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act and related Acts. Types of Inspections: FDA conducts several types of inspections to help protect consumers from unsafe products: Commonly used forms by … Read more