Thus, examining the correlation between physical properties and s

Thus, examining the correlation between physical properties and skin penetration is a topic for the future. The authors wish

to thank Tarumi Toshiyasu of Japan Buchi Co., Ltd. for his helpful advice regarding NIR absorption measurements. The authors would also like to thank all of the subjects who participated in the sensory test. “
“Encouraging generic drugs and substitution from multiple sources into the healthcare system is aimed at maximising population health subject to a budget constraint. This, as a result can improve the overall healthcare delivery systems [1]. For example, in the US, generic Akt signaling pathway drugs represent 47% of all prescriptions dispensed in 1999, 61% in 2006 and 69% in 2008 [2]. Approving generic drugs in the US has resulted in an average savings Everolimus supplier of 77% of the product cost within 1 year [3]. Similarly, the UK’s generic substitutions have been widely successful; they account for 83% [4]. This increase has occurred because any drug products that are considered bioequivalent must be identical in quality (active ingredient, strength, purity, content uniformity, disintegration and dissolution rates) [5]. However, this has been accompanied by a variety of problems of which the most critical is the

widespread distribution of substandard generics and fake drug products. As a consequence, healthcare providers and patients are usually concerned when selecting one drug from among several bioequivalent ones during the treatment regime [5] and [6]. In order to maintain a quality control procedure in research and development, dissolution testing has been employed over the past 50 years to detect the influence of critical manufacturing variables and in comparative studies in-vitro–in-vivo correlation (IVIVC) [7]. It can be used to pin point formulations that may present potential bioequivalence problems. Phosphoglycerate kinase Therefore, it is considered one of the most important tools to predict the in-vivo bioavailability and in some cases replacing clinical studies to determine bioequivalence. Dissolution testing in-vitro is also considered critical

because drug release from the solid dosage form after oral administration is a prerequisite for drug absorption and bioavailability [8]. It is a very important test and considered the rate limiting step in the sequence of steps leading to absorption of the drug into systemic circulation [9]. Absorption is the process of transporting the drug substances from the gastrointestinal lumen into the systemic circulation [10]. It is the first step before the distribution, metabolism and elimination (ADME) properties of drugs in the human body. An important feature of drug quality assurance includes the ability to confirm that the correct manufacturing procedures have been followed for a given batch, that the product performs effectively throughout its shelf life and that batch-to-batch reproducibility of the product meets regulatory requirements [11].

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