Fundamentals of Pharmaceutical Chemistry

Introduction: Pharmaceutical Process

Raw material and its classification
Testing
Procurement
Importance of pharmaceutical chemicals
Processing of pharmaceutical products
Equipment

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.

Source:

Natural – as in the case of vegetable ingredients like Phytopharmaka
Synthetic – artificially manufactured through regulated chemical processes

Many of the raw materials originally obtained from natural sources have been synthetically manufactured in part or even biotechnologically recently. This is because it is economical, safer, and much faster to manufacture them artificially.

Pharmaceutical raw materials are manufactured using different types of acids, alcohols, esters, phenones, pyridines, etc.

Types of Pharmaceutical Raw Products

Fundamentals of Pharmaceutical Chemistry

Types of Pharmaceutical Raw Materials :

Active Pharmaceutical Ingredients (API)
Excipients

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 pharmaceutically inert substances that help in delivering the active ingredient.

Thus, an excipient is an inactive substance formulated alongside the active ingredient (“API”) of a medication

This relates to the drug or tablet substance. If it is in the shape of syrup, then the liquid used will be the excipient.

Excipients – Purposes:

Formulation of API with excipients is mainly to ensure:

An effective drug product with desired characteristics and a robust production process
Consistency of drug release and bioavailability
Stability including protection from degradation
Ease of administration by the planned path to the target patient population(s)

The resulting biological, chemical, and physical characteristics of the drug product are directly influenced by the selected excipients, their concentration, and API interactions.

Excipients – Classification:

Excipients can be categorized according to their origin, use in dosage form, and performing tasks.

Excipients may be classified into the following categories based on their functions:

Antiadherents
Binders
Disintegrants
Fillers and Diluents
Coloring Agents
Glidants
Lubricants
Preservatives
Sorbents
Sweeteners

APIs may be classified into the following categories based on their therapeutic activity:

Antipyretics
Analgesics
Anti-inflammatory
Antibiotics
Antimalarial drugs
Antiseptics
Antiarrhythmic agents
Antidiabetics
Antineoplastic drugs
Antiulcer drugs
Antihistamines
Antivirals
Anti-asthmatic drugs
ACE inhibitors

APIs may also be classified into the following categories:

Inorganic substances
Organic substances (isolated from animal or human material)
Organic substances (synthetic or semi-synthetic or herbal or micro-organism isolated)