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