The ICH quality vision introduced the concept of quality by design (QbD), which requires a greater understanding of the raw material attributes, of process parameters, of their variability and their interactions. Microcrystalline cellulose (MCC) is one of the most important tableting excipients thanks to its outstanding dry binding properties, enabling the manufacture of tablets by direct compr...

it has been observed that most of the chemical entities have high lipophilicity and poor aqueous solubility, which result in poor bioavailability. in order to improve the bioavailability, the release behavior of such drugs should be improved. although there are numerous techniques to handle solubility related issue, but they are expensive due to involvement of complicated equipments, advanced m...

Independent component analysis (ICA) was used as a blind source separation method on a Raman image of a pharmaceutical tablet. Calculations were performed without a priori knowledge concerning the formulation. The aim was to extract the pure signals from the initial data set in order to examine the distribution of actives and major excipients within the tablet. As a method based on the decompos...

INTRODUCTION Pharmaceutical industry is no longer allowed to develop new medicines for use in adults only, as the 2007 Paediatric Regulation requires children to be considered also. The plans for such paediatric development called Paediatric Investigation Plans (PIPs) are subject to agreement by the European Medicines Agency (EMA) and its Paediatric Committee (PDCO). The aim of this study was t...

In this work, a numerical method, based on the use of spectrophotometric data coupled to partial least squares, multivariate calibration is evaluated for simultaneous determination olmesartan medoxomil and hydrochlorothiazide in bulk tablet dosage form. Tablet Olmetor-H (HTZ 12.5 mg OLM 20.0 mg) was used study. The equipment Ultraviolet-Visible double beam spectrophotometer with matching pair 1...

Quality assurance monitoring is of great importance in the pharmaceutical industry for the reason that if defects such as coating layer irregularities, internal cracks, and delamination are present in a drug tablet, the desired dose delivery and bioavailability can be compromised. The U.S. Food and Drug Administration (FDA) established the Process Analytical Technology (PAT) initiative, in orde...

A novel liquisolid compact technique was used for soulbility enahncement of poorly water soluble drug carvedilol (CAR). CAR was dissolved in water miscible non volatile solvent and then adsorbed on a solid carrier which was later compacted with other excipient into a tablet. The tablets were characterized with respect to hardness, friability, disintegration and in-vitro dissolution profile. Eff...

Both the proposed methods were found to be rapid, economical, accurate and precise for the determination of fosinopril sodium in bulk drug and in its tablet dosage form. In results of analysis of marketed tablets by both methods, t-calculated values and F-calculated values were less than the corresponding statistical values, indicating no significant difference in means and variances of results...

The compressional characteristics and tableting properties of starches from four yam species namely Dioscorea dumetorum Pax (Bitter); Dioscorea oppositifolia L (Chinese); Dioscorea alata L.DIAL2 (Water) and Dioscorea rotundata Poir (White) were investigated in comparison with corn starch. The physicochemical properties of the starches were evaluated using established methods while the compressi...

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