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.

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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Tablets and capsules are the most preferred dosage forms of pharmaceutical scientists and clinicians because they can be accurately dosed and provide good patient compliance,

One of the major changes brought about by the introduction of the International Conference on Harmonization (ICH) guidelines for stability testing of pharmaceutical products has been to standardize temperature and humidity testing conditions (1). Although the environment typically consists of temperature, humidity, and light, the ICH still preferred to develop a separate photostability testing guideline because products in ICH member countries are sold in secondary packages, which eliminates the necessity for light testing along with temperature and humidity (2). Although light isn’t considered a main testing factor in several ICH member regions (e.g.,United States, Europe, and Japan), it is an important factor with respect to the sale of products in several countries outside the ICH’s influence.Many tropical countries have adverse environmental conditions, including high temperature, humidity, and intense light.

Many methods have been used to investigate the compression behavior of pharmaceutical excipients. For example, the Heckel plot, which describes the relationship between the porosity of the formulation and the compression pressure, is the most popular technique (1,2). It has also been used to investigate the decompression phase, that is, elastic recovery (3).

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In the past three decades, the pharmaceutical industry has seen
the development of drugs that actually cure disease rather
than just offer symptomatic relief. During these years, the
concepts of improving efficacy and good manufacturing practices
(GMPs) have grown in importance. In addition, toward
the end of the last quarter of the previous century, many new
concepts and terms had come into common usage. For example,
the concept that a dosage form must act to release the active
ingredient has become generally accepted.Words like disintegration,
dissolution, and bioavailability also have gained
prominence and meaning.Accompanying these terms and concepts
was the realization that inactive ingredients frequently
are critical to ensure storage stability, safety, and efficacy of drug
dosage forms. The transition from excipients being perceived
as inactive, inert ingredients to the present status of pharmaceutical

Abstract: The purpose of this study was to evaluate the mechanisms of aggregate formation and excipient stabilization in freeze-dried formulations of a recombinant humanized monoclonal antibody. Protein degradation was measured using sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS PAGE) and native size exclusion chromatography, and protein structure was studied using Fourier transform-infrared spectrometry and circular dichroism. The results showed that protein aggregates present following reconstitution were composed of native antibody structure and a reduced amount of free thiol when compared to protein monomer, which implied that intermolecular disulfides were involved in the aggregation mechanism. An excipient-free formulation resulted in reversible solid-state protein structural alteration and increased aggregation during storage.