Fundamentals of Pharmaceutical Chemistry
Introduction: Pharmaceutical Process
- Raw material and it’s classification
- Importance of pharmaceutical chemicals
- Processing of pharmaceutical products
Pharmaceutical Supply Chain :
*Pharmaceutical Raw Products:
Pharmaceutical raw materials are substances, chemicals, extracts, etc, which are used for manufacturing different types of drugs, for example, anti-infective drugs viz. penicillin, ampicillin, cephradine etc.
- Natural – as in the case of vegetable ingredients like Phytopharmaka
- Synthetic – artificially manufactured through regulated chemical processes
Recently, many of the raw materials previously derived from natural sources are being produced synthetically in part or even bio-technologically. This is so because manufacturing them artificially is economical, safer, and much quicker.
Pharmaceutical raw materials are manufactured using different types of acids, alcohols, esters, phenones, pyridines, etc.
Types of Pharmaceutical Raw Products
Types of Pharmaceutical Raw Materials :
- Active Pharmaceutical Ingredients (API)
Active Pharmaceutical Ingredients (API): Active Pharmaceutical Ingredients (API), also known as bulk active, are portions of any drug which are pharmaceutically active, and have the desired pharmacological effects on the body.
Excipients are the pharmaceutically inert substances which help in delivering the active ingredient.
Ø Thus, an excipient is an inactive substance formulated alongside the active ingredient (“API”) of a medication
Ø This refers to the substance inside the drug or tablet. If it is in syrup form, then the excipient will be the liquid that has been used.
Excipients – Purposes:
Formulation of API with excipients is mainly to ensure:
i.an efficacious drug product with desired properties and a robust manufacturing process
ii.Consistency of drug release and bioavailability
iii.Stability including protection from degradation
iv.Ease of administration to the target patient population(s) by the intended route
The resultant biological, chemical and physical properties of the drug product are directly affected by the excipients chosen, their concentration and interactions with the API.
Excipients – Classification:
Excipients can be classified on the basis of their origin, use in dosage form, and functions they perform.
Excipients may be classified into the following categories based on their functions:
- Fillers and Diluents
- Coloring Agents
APIs may be classified into the following categories based on their therapeutic activity:
- Antimalarial drugs
- Antiarrhythmic agents
- Antineoplastic drugs
- Antiulcer drugs
- Anti-asthmatic drugs
- ACE inhibitors
APIs may also be classified into the following categories:
- Inorganic substances
- Organic substances (isolated from materials of animal or human origin)
- Organic substances (synthetic or semi-synthetic or isolated from herbal sources or micro-organisms)