Design Development and Evaluation of Stable Parenteral Dosage Form for Anti Neoplastic Drugs by Using Lyophilization Technique

Abstract

The incidence of cancer remains common despite discoveries in the field of cancer cells, a variety of surgical methods and molecular biology, radiation and pharmacological interventions in various stages and components of tumor growth, so it is important to create effective drugs against cancer and improve existing therapies. Despite the rapid development of medical technologies, chemotherapy treatment still occupies an important place in clinical oncology. In this sense, current research in this sector focuses on the development of stable pharmaceutical formulations based on new non-infringed excipients. newline newline The present work describes the design, development and evaluation of stable parenteral dosage form for ant-neoplastic drugs like bortezomib and carmustine by using lyophilization (or) freeze drying technique with non-infringed novel excipients composition. Bortezomib for injection was available in market as lyophilized dosage form with two strengths 2 mg/vial and 3.5 mg/vial which is indicated for the treatment of patients with multiple myeloma and mantle cell lymphoma. But the dosage form with mannitol formulation comes under patent space which cannot be infringed for marketing in regulated countries. To overcome this problem, this present research involves the use of non-infringed excipients like lactose monohydrate, citric acid anhydrous and glycine for the formulation of stable dosage form using lyophilization technique with suitable co-solvent system. newline newline newline newline Carmustine for injection was available in market as lyophilized dosage form for 100 mg/vial strength which is indicated for brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. The main criticality is the stabilization of carmustine without any excipients in the final formulation as the drug substance storage condition is -20°C with low melting point of about 25°C and finished product storage condition is 2-8°C.