Pharmaceutical formulations are made through a process in which different chemical substances, including active ingredients and few selected inactive ingredients are combined to produce a pharmaceutical drug.
Active Pharmaceutical Ingredient (API) and Inactive Ingredients
Active Pharmaceutical Ingredient (API) is a term used to refer to the chemically active components in a pharmaceutical drug. Example of pharmaceutical drugs: tablet, capsule, cough syrup, etc. API is the central ingredient in a drug; while the inactive ingredients in it are known as excipients. For example, the acetaminophen in a pain relief tablet is its API; whereas, lactose, glucose, cellulose and the rest are its excipients.
Importance of API in Pharmaceutical Formulations
The purpose of APIs according to FDAis to cause pharmacological activity or other direct effects in care and treatment of diseases. Both prescription and over-the-counter drugs by formulation companies in India are a mixture of APIs and excipients.
Types of Pharmaceutical Formulations:
Let’s have a look at the different types of pharmaceutical formulations from manufacturer of pharmaceutical products.
- Tablets: Immediate-release tablets, sustained-release tablets, delayed-release tablets and film-coated tablets
- Capsules: Powdered and granule filling capsules
- Pellets: Capsule-filled pellets
- Powders: FDA approved powders
- Oral and Parenteral Liquids: Solutions, Suspensions, Emulsions
- Semi-solids: Creams, Ointments, Gels, Lotions
What are the three major considerations to be studied during formulation development?
- Formulation of pharmaceutical drugs is well within the FDA guidelines
- Proper protection of drug formulations from humidity and various external factors
- Whether the bitter or salty odor of drug substances are properly masked or not; for example: coated capsules, sweet syrups