PHARMACEUTICAL DEVELOPMENT OF A FIXED DOSE COMBINATION FORM OF MEMANTINE AND CYTICOLINE WITH MODIFIED RELEASE: RESEARCH OF TECHNOLOGICAL PROPERTIES OF SUBSTANCES

The pharmaceutical development of a fixed dose combination form of citicoline and memantine for the treatment of cognitive disorders, which will improve compliance is a topical area of research. Purpose: to investigate the technological properties of the active pharmaceutical ingredients: memantine hydrochloride and citicoline monosodium salt in the framework of the development of a fixed dose combination modified release. The samples of pharmaceutical substances citicoline "Kyowa Hakko Bio Co., Ltd." (Japan) and memantine hydrochloride - Hetero Drags Limited (India) were used. Technological studies of the substances were carried out in accordance with the requirements of the State Pharmacopoeia of the RF XIV edition. It was revealed that the particles of the investigated substances show an anisodiametric shape, the anisodiametric shape of the analyzed particles indicates possible poor flowability of APIs, which predicts difficulties in dosing during the tablet compression process. The following characteristics were studied: the ability of the powder to compaction, the bulk density and compressibility index, Hausner ratio were established. It was found that, according to the USP classification, the flowability of substances can be characterized as very, very poor. Pharmaceutical substances of memantine hydrochloride and citicoline monosodium salt have unsatisfactory technological properties, which can complicate the processes of die filling and dosing of pharmaceutical substances during tableting tablet compression. To prevent these disadvantages, it is further recommended to provide research on the possibility of using wet granulation, or the usage in the composition of the tablet mass of excipients with a high bulk density and good flowability. Thus, within the framework of pharmaceutical development, the physicochemical properties of the pharmaceutical substances memantine hydrochloride and citicoline monosodium salt were investigated.

A Review on qualification of the tablet compression machine

Validation is the art of designing andpracticing the designed steps alongside with the documentation. Validation is one of themostimportant steps in maintaining &achievingthe quality of the final product group after batch. The qualification of the equipment and systems are planning to carry out the tests and record the tests. We cannot be manufacturing the product, without an equipment. If the equipment is validated, we can ensure that our product is of the top-quality. Validation of the equipment is known as Qualification. To making different kinds of dosage forms, various equipment’s are used. Here, this article concentrates on the equipment qualification for theTablet compression machine. It gives in detail, qualification steps of the equipment, which is used for the manufacturing process through wet granulation. Qualification, an ideal step for equipment validation, is the action undertaken to demonstrate the intended use and performance of the utilities and equipment.The individual steps of qualification such as design, installation, operational and performance qualification, were done in order to qualify the equipment. Blueprint of equipment validation was also included and the tablets were tested for physical parameters such asappearance, punch Shape, punch diameter, upper punch, lower punch, hardness, weight variation, friability, and thickness.

EVALUATING THE BEST POLYETHYLENE GLYCOL AS SOLID DISPERSION CARRIER BY TAKING ETORICOXIB AS A MODEL DRUG

Objective: The main objective of the current research is focused in discovering the best polyethylene glycol (PEG) as solid dispersion carrier using etoricoxib (ECB) as a model drug. Methods: Varieties of PEG, namely PEG - 3350, PEG - 4000, PEG - 6000, PEG - 8000, and PEG - 20000, were evaluated as a carrier for making ECB solid dispersions. ECB:PEG was taken in the ratios of 1:1, 1:2, 1:4, and 1:6. The solid dispersions were prepared by microwave fusion method and compressed using 8 station tablet compression machine. The fabricated solid dispersion tablets were tested for physicochemical characteristics and drug release rates. The release of ECB from the prepared solid dispersions was further analyzed kinetically using the first order and Hixson-Crowell’s plots. Results: All the solid dispersion batches were shown satisfactory physicochemical characteristics. ECB solid dispersion batches with PEG - 6000 showed good solubility in distilled water (up to 2.29±0.01 μg/ml) and in 0.1 N HCl (up to 2.18±0.01 μg/ml) when compared with ECB alone (0.21±0.01 μg/ml and 0.32±0.01 μg/ml). The prepared solid dispersions with PEG 6000 are shown good ECB release. Conclusion: Among PEG carriers, PEG - 6000 was found to be the best carrier for increasing the solubility and release rate of ECB form the solid dispersions compared to PEG - 3350, PEG - 4000, PEG - 8000, and PEG - 20000.

Valuing Best Poloxamer Carrier for Meloxicam Solid Dispersions by novel microwave fusion: Designing and Characterization

Present research activity is to establish the best Poloxamer carriers for making solid dispersions (SD) with Meloxicam. The main aim of this investigation is to find the best among the better Poloxamer carriers viz., Poloxamer-108, Poloxamer-188, Poloxamer-237, Poloxamer-338 and Poloxamer-407 for making SD by novel microwave fusion technique. Four portions of Meloxicam: Poloxamer in various ratios (1:1, 1:2, 1:4 and 1:6) are used for making SD by microwave fusion technique later compressed using 8 station tablet compression machine. The SD and tablet formulations are evaluated for physicochemical characterization. All the prepared batches found to have satisfactory specifications as per pharmacopoeia. The authors concluded that Poloxamer-188 is found to be the best carrier among the Poloxamer carriers used for making Meloxicam SD. Keywords: Meloxicam, Poloxamer, microwave, solid dispersions, tablets