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Excipients

This is a broad class of “inactive” ingredients that are used for multiple functional reasons in pharmaceutical preparations.  These functional ingredients are typically used to add bulk to formulations, facilitate absorption or solubility, improve shelf-life and stability, or act as a processing aid to improve compression, powder flow, or release from tablet presses or other equipment. Excipients can also serve to mask undesirable flavors or off-notes or texture that commonly comes from the “active” ingredients, or could even help to delay the release of the active to make sure that the correct dosage is delivered to the right spot in the body at the right time.

Pharmaceutical standards and regulations require that all excipients used in pharmaceutical preparations be proven safe and suitable for human intake. Food and beverage additives are often times used as excipients because of their proven safety and generally low costs. The FDA has approved the use of several hundred additives for pharma applications, with most of them aimed at use in tablets or capsules, the most popular delivery mechanism for medicines and actives.

Ampak offers a range of excipient products from several world class manufacturers:

Dicalcium Phosphate / Tricalcium Phosphate – produced by Sudeep Pharma.  The granular grades can be further milled to obtain a powder grade, which is typically used in wet granulation processes while the unmilled, granular grade is typically used for direct compression applications.

Calcium Carbonate – also produced by Sudeep Pharma.  Calcium carbonate has a very high acid neutralization power, a high calcium content (40 percent), excellent absorptive power, especially in the form of a high surface area particle, as well as its use as a less expensive filler and extender.

Click here to see the linecard for Sudeep Pharma

Microcrystalline Cellulose – produced by Reliance Cellulosics. As a naturally occurring substance, it has proven track record of being stable, safe and physiologically inert. MCC has unique compressibility, high binding and dilution potential, and excellent carrying capacity allowing for tablets that have very high stability and hardness, yet that still disintegrate rapidly. All of this makes MCC an ideal excipient.

Click here to see the linecard for Reliance Cellulosics