Bendamustine hydrochloride, a thermolabile biopharmaceutical, in lyophilized form is unsteady proving difficult to maintain activity and shelf life. To counterbalance the thermo-fragile nature of this product and eliminate limitations of lyophilization an alternative method with rational selection of stabilizers is developed. The present research work was aimed to screen sugar-phosphate composite mixtures to enhance storage stability of drug using evaporative foam drying. The effect of foaming agents and their strengths, pH and temperature on product features were investigated. The physicochemical stability of products prepared using sugars, polymer and inorganic water soluble phosphates alone and in combination was studied. The products were characterized for residual moisture, reconstitution time and drug content. The amount of drug retained after processing and at storage was analyzed by HPLC. Foam dried products were tested for short term stability as per ICH guidelines for biologicals. Pluronic® F108 at 0.6% exhibited optimum foamability. Foams were stable at 0.4% polyvinyl pyrrolidone K30. The enhancement in drug stability by evaporative foam drying attributed to electrostatic interaction between protonable groups of drug and deprotonable groups of composite stabilizer mixture during dehydration. The processing and storage stability of drug in composite glass was superior at normal storage. Proper selection of stabilizers for this technique is a key to successful stabilization of drug at ambient temperatures without loss of their activity during shipping and storage without refrigeration.
Cite this article:
Hajare Ashok A, More Harinath N., Nazare Pravin S. . Foam Dried Composite Glass: An alternative to Lyophilization for Stability Enhancement of Bendamustine Hydrochloride. Research J. Pharm. and Tech 2016; 9(10):1602-1610.. doi: 10.5958/0974-360X.2016.00318.8