Skip to main content

Renin Angiotensin Mechanism.

Innovator and Generics in Pharmaceutical Science.

 

  • Introduction:

    • In the field of pharmaceuticals, understanding the distinction between innovator drugs and generic drugs is crucial. Let’s see the key aspects of both categories.

  • Innovator Drugs:

  • Definition: An innovator drug (also known as a branded drug) is the first drug containing a specific active ingredient to receive regulatory approval for use.

  • Characteristics:

    • Pioneering: Innovator drugs are groundbreaking and often represent significant scientific advancements.

    • Safety and Efficacy: Their efficacy, safety, and quality have been fully established through rigorous clinical trials.

    • Patent Protection: The company that develops an innovator drug usually holds a patent for it, granting exclusive rights to manufacture and sell the drug for a specified period (typically up to 20 years).

    • Example: The first version of a drug used to treat a particular condition (e.gSitagliptin, an oral hypoglycemic drug patented by Merck and Co.).

Generic Drugs:

  • Definition: A generic drug is a medication created to be identical to an existing approved brand-name drug in terms of dosage form, safety, strength, route of administration, quality, and performance characteristics.

  • Characteristics:

    • Equivalence: Generic drugs are bioequivalent to their innovator counterparts.

    • Cost-Effective: Since generic manufacturers don’t need to invest in extensive research and development, these drugs are usually more affordable.

    • Regulatory Approval: Generic drugs undergo a streamlined approval process based on the concept of abbreviated new drug applications (ANDAs).

  • Example: A generic version of a well-established drug (e.g., a generic version of Nimesulide).

 Commonly Asked Questions:

  1. Write a short note on Innovator and Generic Drugs.

  2. Differentiate Innovator and Generic Drugs.

Labels:

Popular posts from this blog

Heat Exchangers and Heat Interchangers.

  In pharmaceutical industries many types of equipments are used for transfer of heat, they can be classified as follows, Heat Exchangers. Heat Interchangers. Heat Exchangers: These devices are used for transferring heat from a fluid (Hot Gas or Steam) to another fluid (Liquid) through a metal wall. Heat Interchangers: These devices are used for transferring heat from a One liquid to another liquid or one gas to another gas through a metal wall. HEAT EXCHANGERS; The equipment used for heat transferring are known as heat exchangers. Some of the processes that involves heat transfer in pharmaceutical industries are: Preparation of starch paste (in steam jacketed kettle). Crystallization. Evaporation. Distillation.  Classification of heat exchangers On the basis of transfer of heat, heat exchangers are classified as: Direct transfer type:  The hot and cold fluids are separated by a metal wall through which the heat is transferred from hot fluid to cold fluid. E.g. shell and ...
Read more

Rate of Drying Curve.

  Definition Drying is defined as the removal of liquid from a product usually with application of heat. Rate of Drying Curve. Drying process can be divided into three periods Initial Adjustment Period. Constant drying rate period. First falling drying rate period. Second falling rate period. Initial Adjustment Period (A-B): Also called the “ Heating up” period . In this period the substance gets heat and increases in temperature. Drying has not yet started. Constant drying rate period (B-C): During this period the temperature of the solid and the rate of drying remain constant. The moisture evaporating from the surface is replaced by water diffusing from the interior of the solid at a rate equal t o the rate of evaporation.  The moisture content at the end of constant rate (point C) is referred to as the critical moisture content (CMC).  At CMC, dry spots start appearing and drying rate starts falling . First falling drying rate period (C-D): This period is also called ...
Read more

Flash Distillation.

  Principle: When a hot mixture is allowed to enter from a high-pressure zone into a low pressure zone, the entire liquid mixture is suddenly vaporized. This process is known as flash vaporization .  During this process, the chamber is cooled.  The less volatile fraction is condensed and the more volatile component remains in the vapor phase .  This process requires time, hence liquid and vapor are kept in intimate contact until equilibrium is achieved. Flash distillation is also called equilibrium distillation because separation of two liquids takes place when liquid and vapor phases are at equilibrium. Equipment used for Flash Distillation: Construction: It consists of a pump, which is connected to a feed reservoir.  Pumps help in pumping the feed into the heating chamber.  The heating chamber is heat supplied by steam.  The other end of the pipe is directly introduced into the vapor-liquid separator through a reducing valve.  The vapor outlet...
Read more