Excipients

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Review of Current Issues in Pharmaceutical Excipients

Drug dosage forms can be rather complex systems containing many components in addition to active pharmaceutical ingredients (APIs). Formulators apply practical understanding of pharmaceutical excipients to develop optimal, robust formulations and the appropriate manufacturing processes. Technical information about these excipients is readily available (1–2). The authors review some of the important issues regarding pharmaceutical excipients, current industry trends in using pharmaceutical additives, and basic principles of formulation design.

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Journal: 
Pharmaceutical Technology, May 2, 2007.
Articles: 

Pass the buck --Do you know who pays for your products?--

SELLING PHARMACEUTICALS in a managed care environment presents unique challenges, because two distinct entities exert enormous influence on a patient's decision to purchase and use a pharmaceutical product. The first and most obvious influence is the physician. The second influence is the organization or individual that pays for the prescription.

To maximize sales in a managed care environment, pharmaceutical representatives must have a solid understanding of three concepts:

Who is ultimately paying for pharmaceuticals.
How these payers exert influence over the sale of a pharmaceutical product.
How to leverage the payers' influence to maximize a product's sales.

Journal: 
Pharmaceutical Representative, Jan 1, 2007 .
Articles: 

Added Functionality Excipients: An Answer to Challenging Formulations

Tablets and capsules are preferred drug delivery vehicles because they can be precisely dosed, easily manufactured and packaged on a large scale, and can contribute to good patient compliance. Over the years, significant advances in the manufacturing processes of oral solid dosage forms have occurred, including the transition from tablet preparation by wet granulation to direct compression. The development of various added functionality excipients (AFEs), which are used to achieve formulations with desired end-effects, is equally important. The majority of excipients used in the manufacture of solid oral dosage forms have existed for the past two to three decades, many of them continue to be used today for large-scale tablet and capsule manufacturing.

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Journal: 
Pharmaceutical Technology EXCIPIENTS SOLID DOSAGE FORMS 2004.
Articles: 

Excipient Functionality

Excipient functionality” is one of the latest buzz phrases, but it is frequently used by those who have little understanding of the particular nature of excipients. Excipients are not active pharmaceutical ingredients (APIs) and they do not treat medical conditions. But without them, the therapeutic revolution of the past 50–60 years could not have occurred. The watchwords for APIs and finished products are—and rightly so—safety and efficacy. Although the emphasis on APIs and analytical chemistry has resulted in many very good methods for assay development and the determination of purity (including impurities), it is clear that we still lack the understanding and the means to determine why some materials behave in certain ways when included in a formulation (i.e., their functionality).

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Journal: 
Pharmaceutical Technology MAY 2004.
Articles: