Formulation and Evaluation of Novel Antineoplastic Dosage Forms.
This study examines the rationale for intellectual property protection in the development of products useful for pharmaceuticals. This study is developed to evaluate the Non-infringing (NI) lyophilized compositions of antineoplastic drug candidate to bypass the existing patents and provide patients drug at affordable price. Antineoplastic drug is Nitrogen mustard. Bendamustine Hydrochloride (further referred in this article as Bendamustine HCl) is marketed in India as Bendamustine HCl by two different manufacturers (M1 & M2) and supplied as a lyophilized product. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with Bendamustine HCl, such as neoplastic diseases.