Tapentadol is a novel centrally-actingopioid analgesic. Analytical method validation established by laboratory studies that the performance characteristics of the method meet the requirements for the intended analytical application. The user generates proof on the accuracy, precision, specificity, the limit of detection, the limit of quantitation, linearity, range, and robustness of the method for in-house application. For qualitative and quantitative testing of drug analytical method validation plays an important role for safety compliance while developing drug products. It attempts to summarize guidelines by different regulatory bodies and also a summary of the testing method published in different journals.

Objective: To develop a simple, sensitive, specific, and inexpensive HPLC method for measuring of tapentadol hydrochloride in its tablet dosage form. Method: The chromatographic separation was achieved by using Waters Spherisorb C18R 150mm x 4.6mm (5µm) and Shimadzu C18 R 150mm x 4.6mm (5µm) column as stationary phase using phosphate buffer pH 2.5 and methanol at 80:20 ratio as mobile phase at a flow rate of 1ml/min. in isocratic mode. The detection of the selected wavelength after scanning the standard solution was found to be 215nm. Result: The tapentadol calibration curve was linear from 80% to 120% solution. The value of the correlation coefficient (r²) was found to be 0.9938. The % recovery of Tapentadol was found in a range of 99.86 – 101.44. Intermediate precision was performed and %RSD was found to be 0.96. The limit of detection of Tapentadol was found to be 0.027346µg/ml and the limit of quantitation was found to be0.4453µg/ml.

Themain goal of pharmaceutical research is to design products with ensured quality to treat diseases effectively. Patient and clinician compliance is crucial to Triple Crown bench-to-bedside translation. Materials of pharmaceutical interest (MPIs) are classified into two main classes: Active pharmaceutical ingredients (API) and nonpharmacological active excipients. The former trigger a pharmacological response, while the latter is incorporated into the formulation to improve its (bio) pharmaceutical properties and performance. One of the challenges in early and late PR and D is the drug's poor aqueous solubility and permeability. This property is common to approximately 50% of the APIs on the market, and it represents a crucial hurdle during the stages of drug product development. Moreover, low solubility in biological fluids ends up into restricted absorption in the gastrointestinal tract (GIT) and restricted bioavailability; the oral route is the most well-known one; in addition, this route is usually associated with hepatic first-pass metabolism, chemical and enzymatic degradation in the GIT medium, basolateral-to-apical efflux by pumps of the ATP-binding cassette super family (ABCs) and reduced bioavailability. The simplest strategy to avoid these disadvantages is the parenteral route. However, it provokes tissue damage, pain, and patient incompliance. Moreover, systemic exposure typically results in adverse effects that cannot be easily controlled. The oral route is also less feasible when more prolonged release kinetics is demanded owing to the short gastric emptying and intestinal transit times. The emergence of micro and nanotechnologies, with the implementation of noninvasive and painless administration routes, has revolutionized the pharmaceutical market and the treatment of disease. The interest in capitalizing the mucus layer that covers the surface of a variety of organs by developing mucoadhesive dosage forms that remain in the administration site for more prolonged times, increasing the local and systemic bioavailability of the administered drug using nanotechnology, is on the rise. Aiming to overcome the mayoral route's main drawbacks and maintain high patient compliance, the engineering of innovative drug delivery systems (DDS) administered by mucosal routes has come to light and gained the scientific community's interest in the possibility of changing drug pharmacokinetics dramatically. In addition, to achieve t, the development of biomaterials has been refined to fit the specific applications to achieve the goal of many drug administration materials having a strong affinity for mucosal surfaces and adhering to the surface of these tissues. Drugs may be physically or chemically bound to these mucoadhesive to increase their residence time at a specific location in the body. Additionally, the mucoadhesive effect allows for site-specific delivery of drugs to the mucosa. In some cases nanoparticles are not able to prolong the drug release for an extended per period to that reason, only mucoadhesive drug delivery systems are developed³. The current review presents an updated summary of manyadhesion theories, polymers used for mucoadhesion and their possibilities.

Ayurevedic system of medicine, which is originated in India long back in prevedic period, deals elaborately with measures for healthful living during the entrire span of life and its various phases. The important step involved in the procedure for making Ayurvedic formulation plant juices and high temperature calcinations.It’sone of the herbo-mineral preparation in which the herbal Plant Althaea officinalis L, Amaranthus spinosus and Cinnamomumcamphorawas treated with Lime Water. This preparation has been administrated along with adjuvants such as butter, ghee or honey. This can lead to better absorption, bioavailability and to reduce the toxicity of the particular test drug. Unique- herbal Ayurvedic preparation, used in the treatment of pulmonary complications such asasthma, wheezing and tuberculosis and it is one of unique metallic-herbal Ayurvedic preparation.

The study “Formulation and evaluation of mouth dissolving tablets of Metformin HCl” revealed that the FTIR study it is confirmed that no interaction took place between the drug and other excipients used in the formulation procedures. The characteristic peaks of the pure drug were compared with that obtained with different blends which nearly same. The thin layer chromatographs of pure drug and that of different formulation blends confirmed approximately equivalent Rf values. Conclusively metformin HCl was found to be compatible with both polymers and other ingredients incorporated in the formulations. The Various physicochemical parameters determined with the tablets were bulk density (0.4-0.73g/cc), tapped density (0.64-0.85g/cc), carr’s index (14-34%), angle of repose (30-44) and Hausner ratio (1.22-1.54). Other evaluation parameters included in-vitro drug release in buffer systems (98%-100%) and in simulated physiological media (98%-100%). The in-vitro release of the drug with best formulation (B3) in simulated medium was found to be 99.67% which showed fast release over a period of 30 mins. The stability study was performed with the optimizied formulation (B3) under prescribed conditions which showed that these formulations were stable and thus complied with dose conformity criteria.