Modh Nirav, Mehta Dharmik, Parejiya Punit, Popat Amirali, Barot Bhavesh
Regulatory Affairs, Astron Research Ltd., Premier House, Opp. Gurudwara, S.G Highway, Bodakdev, Ahmedabad -380054, Gujarat, India.
Recent Pat Drug Deliv Formul. 2014;8(2):144-54. doi: 10.2174/1872211308666140422150819.
Pharmaceutical scientists involved in drug discovery and drug development are facing serious problems with newer poorly water soluble drugs with respect to their dissolution and bioavailability. Reducing the particle size of active pharmaceutical ingredient has been an efficient and reliable method for improving the bioavailability of insoluble drugs. Nanosuspension has emerged as an efficient and promising strategy for delivery of insoluble drugs due to its unique advantages such as ease of modification, process flexibility, targeting capabilities, altered pharmacokinetic profile leading to safety and efficacy. These unique features of nanosuspension have enabled its use in various dosage forms, including specialized delivery systems such as oral, parenteral, peroral, ocular and pulmonary routes. Currently, efforts are being directed to extend their applications in site-specific drug delivery. Large numbers of products based on nanosuspension are in the market and few are under clinical trials. The commercialization potential of nanosuspension based formulation for oral route is well established and products for other routes will enter the market within short span. Among the various techniques available, only wet milling technique has been successfully used for commercial production of nanosuspension. Nanosuspension based patents have extensive potential of reaching faster in the market as compared to other nanotechnology based formulations. This review covers various aspects of techniques of preparation, route of administration and commercialization of nanosuspension with main focus on the recent patents granted in the field.
参与药物发现和药物开发的制药科学家在处理新型难溶性药物的溶解和生物利用度方面面临着严重问题。减小活性药物成分的粒径一直是提高难溶性药物生物利用度的一种有效且可靠的方法。纳米混悬液因其独特优势,如易于修饰、工艺灵活性、靶向能力、改变药代动力学特征从而提高安全性和有效性等,已成为递送难溶性药物的一种有效且有前景的策略。纳米混悬液的这些独特特性使其可用于多种剂型,包括口服、注射、经口、眼部和肺部等特殊给药系统。目前,人们正致力于将其应用扩展到特定部位的药物递送。大量基于纳米混悬液的产品已投放市场,还有少数正在进行临床试验。基于纳米混悬液的口服制剂的商业化潜力已得到充分证实,其他给药途径的产品也将在短时间内进入市场。在现有的各种技术中,只有湿磨技术已成功用于纳米混悬液的商业化生产。与其他基于纳米技术的制剂相比,基于纳米混悬液的专利具有更大的市场推广潜力。本综述涵盖了纳米混悬液的制备技术、给药途径和商业化等各个方面,主要关注该领域最近授予的专利。