What are excipients in pharmaceuticals?
Pharmaceutical excipients are substances that are included in a pharmaceutical dosage form not for their direct therapeutic action, but to aid the manufacturing process, to protect, support or enhance stability, or for bioavailability or patient acceptability.
What are the types of excipients?
Examples include gelatin, cellulose, cellulose derivatives, polyvinylpyrrolidone, starch, sucrose and polyethylene glycol. Dry binders are added to the powder blend, either after a wet granulation step, or as part of a direct powder compression (DC) formula.
What are the common excipients used in pharmaceutical industry?
Main Excipients
- Magnesium Stearate.
- Microcrystalline Cellulose.
- Starch (corn)
- Silicone/Titanum Dioxide.
- Stearic Acid.
- Sodium Starch Glycolate.
- Gelatin.
- Talc.
What is the role of excipients?
The intended function of an excipient is to act as the carrier (vehicle or basis) or as a component of the carrier of the active substance(s) and, in so doing, to contribute to product attributes such as stability, biopharmaceutical profile, appearance and patient acceptability and to the ease with which the product …
Is water an excipient?
Water is one of the major utilities used by the pharmaceutical industry. It may be present as an excipient or used for reconstitution of products, during synthesis, during production of the finished product or as a cleaning agent for rinsing vessels, equipment, primary packaging materials, etc.
Do excipients need to be GMP manufactured?
Some excipient manufacturing processes may require observance of GMP applicable to finished drug products or bulk active ingredients because of the excipient’s intended use. However, such observance is neither feasible nor necessary in many processes, particularly during the early processing steps.
Is microcrystalline cellulose bad for the body?
According to the Select Committee on GRAS Substances, microcrystalline cellulose is generally regarded as safe when used in normal quantities.
What is hypromellose made from?
Hydroxypropyl methylcellulose (HPMC), also known as hypromellose, is produced from cellulose, a natural polymer and fiber, which is considered to be safe for human consumption. HPMC undergoes a rigorous manufacturing process involving the synthetic — and not natural — alteration of cellulose.
What is the difference between active ingredient and pharmaceutical excipients?
Pharmaceuticals. The dosage form for a pharmaceutical contains the active pharmaceutical ingredient, which is the drug substance itself, and excipients, which are the ingredients of the tablet, or the liquid in which the active agent is suspended, or other material that is pharmaceutically inert.
Are pH adjusters excipients?
pH modifier excipients are used in the pharmaceutical industry due to their antioxidant properties. pH modifiers can help maintain the stability of pharmaceutical and can also be used as preservatives. For pH-modification, the addition of a base or an acid is often preferred over the use of buffers.