Development of a Validated HPLC Method for the Estimation of Metformin HCl and Propranolol HCl.

The present investigation targets to develop a simple, specific, sensitive and accurate reverse phase high performance liquid chromatographic (RP-HPLC) method in human plasma for the estimation of metformin HCl and propranolol HCl from bulk drug and also from the marketed products. Human plasma samples were subjected to correct procedure for protein precipitation by methanol and protein free plasma samples were directly injected into HPLC C18 column. Chromatographic determination was performed on a reversed phase C18 column (3.9 mm X 300 mm, particle size 5 μm) using a mixture of acetonitrile and 0.1M pH 4.5 potassium dihydrogenortho phosphate buffer (mL) (40:60) at a flow rate of 0.8 mL/min and maintained at a pressure of 140 to 150 Kg/cm2. The retention time for metformin HCl and propranolol HCl was found to be 9.084 min and 6.132 min respectively at 232 nm without any interference of endogenous compounds in the plasma. The method was linear in the range between 50-2000 ng/mL. The peak areas were reproducible as indicated by low coefficient of variation. It was found that the excipients in the tablet dosage form do not interfere in the quantification of active drug by proposed method.

Comparative Quality Control Evaluation of Atenolol Tablets Marketed in Kuala Lumpur, Malaysia.

Background: The emergent of many pharmaceutical companies producing their own generic type of drugs after the patent of innovator drugs expired can improve the general healthcare delivery systems as well as decreasing the healthcare costs. But it also raises a few issues with one of it is the widespread of substandard and counterfeit product. Postsurveillance study to assess product parameter of various generics drug marketed is crucial. This kind of monitoring reduces a country’s economical burden on health issues from diseases due to fraudulent and substandard drugs usage. Purpose: The main objective of this study is to perform a comparative evaluation of the physicochemical properties of five commercially available leading brands of Atenolol tablets marketed in Kuala Lumpur. Method: The quality control parameters of five different brands of atenolol tablets were atenolol tablet assessed included uniformity of content, uniformity of weight, friability, crushing strength, disintegration and dissolution tests as well as content uniformity of the tablets. All the tablets were assessed for conformity with British Pharmacopoeia (BP) standards. Results: All the five brands of the tablets passed the British Pharmacopoeia (BP) standards for weight uniformity, disintegration, friability, content uniformity and hardness tests. Conclusion: The quality control parameters of all five top selling brands of atenolol tablets marketed in Kuala Lumpur analyzed passed all the BP and USP quality specifications and were physically and chemically equivalent.

Formulation of gastroretentive floating drug delivery system using hydrophilic polymers and its in vitro characterization

The aim of the present research is to formulate and evaluate the gastroretentive floating drug delivery system of antihypertensive drug, propranolol HCl. Gastroretentive floating tablets (GRFT) were prepared by using a synthetic hydrophilic polymer polyethylene oxide of different grades such as PEO WSR N-12 K and PEO 18 NF as release retarding polymers and calcium carbonate as gas generating agent. The GRFT were compressed by direct compression strategy and the tablets were evaluated for physico-chemical properties, in vitro buoyancy, swelling studies, in vitro dissolution studies and release mechanism studies. From the dissolution and buoyancy studies, F 9 was selected as an optimized formulation. The optimized formulation followed zero order rate kinetics with non-Fickian diffusion mechanism. The optimized formulation was characterised with FTIR studies and observed no interaction between the drug and the polymers.

O objetivo da presente pesquisa é o de formular e avaliar o sistema de liberação de fármaco gastrorretentivo flutuante, contendo o anti-hipertensivo, cloridrato de propranolol. Comprimidos gastrorretentivo flutuantes (GRFT) foram preparados utilizando um polímero hidrofílico sintético, o óxido de polietileno, de diferentes graus, tais como GE WSR N-12 K e GE 18 NF, como polímeros de retardamento de liberação, e carbonato de cálcio, como agente gerador de gases. Os GRFT foram comprimidos por compressão direta e avaliados para determinação das propriedades físico-químicas, flutuabilidade in vitro, estudos de inchamento, de dissolução in vitro e de mecanismo de liberação. Dos testes de dissolução e de flutuabilidade, selecionou-se F 9 como formulação otimizada. A formulação otimizada seguiu cinética de ordem zero, com mecanismo de difusão não-Fickiano. Essa formulação foi caracterizada por estudos de FTIR, não se observando interação entre o fármaco e os polímeros.

biphasic release system of lornoxicam based on "tablets in capsule" device

The aim of the present investigation is to obtain a programmed drug delivery from a novel system containing a fast release and prolonged release tablet [PRT] placed into a capsule to achieve the biphasic release pattern of lornoxicam. Fast release tablets [FRT] with 3.25 mg were prepared with different diluents and varying concentrations of disintegrant and binders. Hydrogenated castor oil and hydrogenated vegetable oil are used to modulate drug release for the development of PRT with a 12.25 mg dose calculated as a zero-order principle. The compressed tablets were evaluated for various physicochemical parameters like hardness, friability, drug content uniformity, weight variation and in-vitro drug release studies. The optimized FRT and PRT tablets were placed in the size 2 capsule to attain biphasic release in which the immediate rapid release was obtained by the FRT followed by slow release from the PRT for 24 hours. The optimized 'tablet in capsule' [TCHV] [containing 3%w/w of HVO] followed first-order release with a Non-Fickian diffusion mechanism. FT-IR studies revealed no interaction between the drug and polymers. There were no marketed dosage forms of lornoxicam with biphasic release; hence, the present study indicated the applicability of the 'tablets in capsule' technique in the design of biphasic release systems of lornoxicam