Current Issue : October - December Volume : 2012 Issue Number : 4 Articles : 6 Articles
To produce the pharmaceutical dosage forms via hot-melt granulation, a pharmaceutical grade polymer must be selected that can be processed at a relatively low temperature due to the thermal sensitivity of most drugs. Melt granulation is a process by which pharmaceutical powders gets converted to granules form by the use of a binder which can be a molten liquid, a solid or a solid that melts during the process. For accomplishing this process, the apparatus of choice comprises of high-shear mixers, Rapid mixer and granulator etc. where the product temperature is raised above the melting point of the binder either by a heating jacket. More recently, this work also describes a hot melt granulation technique to improve the dissolution characteristics of a poorly water-soluble drug and sustained release property. Melt granulation technique is a process by which pharmaceutical powders are efficiently agglomerated by a meltable binder. The advantage of this technique compared to conventional granulation is that no water or organic solvents are needed. Because there is no drying step, the process is less time consuming and uses less energy than wet granulation....
Recent advances in the mixing technique have lead industries to the new direction for formulation of different dosage forms. Efficiency and specificity for mixing of solid, liquid, semi solid etc dosage forms have substantially enhanced using different advances. Modification to the existing trend in mixing can be done to give newer beneficial technology. Application of low frequency field enhances mixing technology of multi phase system in resonance acoustic mixing. It creates micro-mixing zones throughout the entire mixing vessel. Operating with multiple stationary agitators is exceptionally versatile for the production of viscous paste and emulsions in the cosmetic, pharmaceutical, food and chemical industries. The agitators can be engaged in any combination and at any speed for any interval during the mixing cycle. An Ultra High Shear can achieve the desired process goals in a single pass. With the Ultra High shear mixer, it was possible to optimize mixing lines for low viscous and high viscous slurries. Static mixer delivers rapid mixing with very low head loss. Its computer-designed orifice with bent tabs generates complete mixing through a combination of alternate vortex shedding and intense shear zone turbulence. Double planetary mixer is ideal for mixing and kneading viscous pastes under atmospheric or vacuum conditions....
Glimepiride is having poor water solubility and suffering with dissolution rate limited bioavailability. It belongs to class II category under biopharmaceutical classification and needs improvement of dissolution. Various approaches for improving dissolution rate were reported previously but there is no reports regarding the impact of pharmaceutical factors on the dissolution rate of Glimepiride. The present study is representing the data regarding the effect of various excipients (diluents, superdisintegrants, and lubricants) and method of preparation on the dissolution rate of Glimepiride. Glimepiride tablets composed with the diluent (dicalciumphosphate), super disintegrant (sodium starch glycolate), lubricant (stearic acid) and compressed by employing wet granulation technique produced more drug release among the other formulations and offered the similarity with the marketed formulation....
The Liquisolid technique is a new technique for the drugs which has solubility problem. This technique proved to increase dissolution of poor water soluble drugs. In this technique liquid medications such as solutions or suspensions of water insoluble drugs in suitable non-volatile liquid vehicles can be changed into suitably flowing and compressible powders via blending with elected powder excipients. In these drug is held in solution around & excipient powder in surrounding, so drug is present in solubilised form, which increase dissolution....
Today’s packaging materials and technology used for the packaging of food and pharmaceuticals products has increased the momentum of packaging development and a need has immerged to develop the new generation of packaging that that can fulfill the socio-economic needs of the consumers, providing the end product with standard quality, overcome the problems of counterfeit and environmental pollution. The modern approaches like SMS, RFID etc. and use of biodegradable packing material together can provide a better and suitable new generation packaging that can overcome the limitations of present packaging technology. A Need of harmonization is required in the national and International regulatory bodies to regulate the standards of the packaging material....
Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated we can assure that the final product is of the best quality. Validation of the individual steps of the processes is called the process validation. Validation is found on, but not required by regulatory departments and is best viewed as an impartment and integral part of cGMP. Validation is therefore one element of quality assurance programs associated with a particular process. Then word validation simply means “assessment of validity” or action of proving effectiveness. The goal of quality system is to consistently produce products that are suitable for their intended use. Process validation is a key element in assuring that these principles and goals are met. In this study concurrent process validation was carried out for one product....
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