Composite Anti-Retroviral Drug and its Process
The present technology provides a pharmaceutical composition of anti-retroviral drugs having improved dissolution, content uniformity and bulk properties for use in pharmaceutical field and also a method of preparation of the product. It relates to a process of preparing pharmaceutical composition with improved process and product performance. Tablets and capsules are the most preferred dosage forms by the pharmaceutical scientists and clinicians because of accurate dosing, good patient compliance, manufacturing ease and low cost of production. But, pharmaceutical process can introduce significant amount of stress and alter the molecular interactions in the bulk material engendering solid state transformations. Also, variability due to processes such as wet granulation/dry granulation/direct compression, and the use of different equipments, can introduce differences in the dosage form causing a sub-optimal performance. Subsequently, in this technology spray drying is used for preparing the pharmaceutical composition. Spray drying is a versatile technology with multiple applications and is able to deliver very fine particles. This process generates quality products in terms of improved physico-technical properties and the end product generated can be readily filled into capsule shells or compressed to tablets, only requiring minimal processing step like, lubrication which is unlikely to affect the performance to any considerable extent. The spray drying process is used here as - a solution/dispersion of the material of interest is brought together with sufficient volume of hot air leading to evaporation and drying of the liquid droplets. It is sprayed into a current of warm filtered air, which supplies the heat of evaporation and conveys dried product to a collectingdevice. The air is then exhausted with removal of moist air by suction. By manipulating the various working parameters of atomization pressure, drying air temperature, feed solution concentration and flow rate to the atomizer it is possible to control the shape, size and morphology of the final particles formed in the vessel. During the spray drying process organic solution containing nevirapine and stavudine are co-introduced with sufficient volume of hot air, to induce evaporation and drying of the liquid droplets. Drug solution is sprayed into a current of warm filtered air, which supplies the heat of evaporation and conveys dried product to a collecting device. The moist air is then exhausted with removal by suction. The spherical shaped crystals generated by the present invention offer an advantage, over rod shaped and irregular shaped crystals in terms of improved flowability and compressibility, required for pharmaceutical unit operations.
Sector: Medical Technologies
Area of Application: Medical diagnostics
Keywords: Anti-Retroviral,Immunodeficiency Virus (HIV)
Advantages: Process description and method of preparation of a pharmaceutical composition with improved process and product performance. A pharmaceutical composition comprising a coprocessed product of nevirapine and stavudine. Single processing step Enhanced dissolution rate of nevirapine. Cost-effective production Improved content uniformity of stavudine. Enhanced oral bioavailability
Environmental aspects: Not Applicable
Development Status: Laboratory Model
Legal Protection: Patent in Progress
Transfer Terms: Technology Licensing
Target Countries: India
Estimated cost (US$):
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