Pharmaceutical Manufacturing Process

The pharmaceutical manufacturing process involves combination of various methods selected as per the physical & chemical features of the active pharmaceutical ingredient (API).

An abbreviated new drug application (ANDA) covers data which is submitted to USFDA for the review & approval of a generic pharmaceutical drug. Once the generic drug manufacturing company gets the approval it can manufacture & sell the generic drug.

• Powder Blending: To get the Finished Dosage formulation, excipients are blended together & form a final blend.
• Dry Granulation: It is a procedure in which granules are formed without the help of any liquid solution.
• Fluid Bed Granulation: Raw materials are first turned into fluid by hot air. Granulation fluid is then sprayed onto the pre blended material until the desired moisture content or granule size is achieved.
• High Shear & Wet Granulation: Used to turn a fine-powder into an even granulation, with augmented particle size & higher density, in a short period & with repeatability.
• Hot Melt Extrusion (HME): It is used to enable delivery of drugs with poor solubility & bioavailability to disperse active pharmaceutical ingredients (APIs) in a matrix at the molecular level, thus forming solid solutions.
• Drying: Controlling moisture content of powders is crucial to pharmaceutical process. Fluid bed or laminar flow drying conditions have a significant impact on both physical and chemical characteristics of powder and granules.
• Milling: The application of mechanical energy to physically break down coarse particles to finer ones. Fine particles are required for formulations designed for parenteral, respiratory and transdermal use.
• Compression: The process of producing a solid Finished Dosage formulation (FDF) by Compression of Powder or Granules Into tablets.
• Tablet Coating: It is a process by which a dry coating material is applied to the surface of a tablet in order to add some benefits over uncoated tablet i.e. to improve taste, smell, appearance, handling etc.
• Encapsulation: The containment of a formulation in a soft gelatin shell or a hard shell.
• Micronization: It is the process of reducing the particle size of pharmaceutical products to make them more stable & effective.