Since the introduction of azidothymidine in 1987 there have been major improvements in the treatment of HIV. In a recently published study, Forsythe and colleagues demonstrate that the advent of antiretroviral therapy (ART) in the mid 1990s has yielded significant achievements in global public health. Between 1995 and 2015, 9.5 million deaths have been averted worldwide, and global economic benefits are estimated at over $1 trillion.
The US Food and Drug Administration (FDA) on Tuesday approved the first biosimilar to Amgen’s blockbuster Epogen/Procrit (epoetin alfa), bringing the total number of biosimilars approved by the agency to 10.
Zidovudine (AZT) mucoadhesive solid dispersions (SD) were prepared using a sodium starch glycolate (SSG) and hypromellose phthalate (HPMCP) mixtures as carrier to enhance the intestinal permeability and bioavailability of zidovudine. SDs were prepared using the co-precipitation method followed by solvent evaporation and characterized according to their physicochemical properties such as particle size, crystallinity, thermal behavior, and liquid uptake ability. In vitro drug dissolution, mucoadhesiveness and AZT intestinal permeability were also determined. Thermal behavior and X-ray di raction patterns demonstrated the amorphous state of AZT in SD systems. The HPMCP polymer restricted the liquid uptake ability in the acid medium; however, this property signi cantly increased with higher pH values. SDs allowed drug dissolution to occur in a controlled manner. HPMCP decreased the dissolution rates in the acid medium. The mucoadhesiveness of SDs was demonstrated and the permeability of AZT carried in solid dispersions was signi cantly improved. The e ect of the SD carrier polymers on blocking e ux pump can be an important approach to improve the bioavailability of AZT.
On February 5, 2016, the World Health Organization (WHO) made available the Public Inspection Report (PIR) for Strides Shasun Ltd’s (Strides) Formulation II facility in Puducherry, India. According to the PIR, the inspection focused on Good Manufacturing Practices (GMPs) and resulted in the company remaining in continued compliance for the next three (3) years pending any additional inspections during this time period. This facility was acquired by Strides through its acquisition of Shasun Pharmaceuticals Limited (Shasun) after the company sold certain sterile facilities to Mylan.
Anvisa decided to suspend the import of Erythropoietin and Interferon Alfa 2 to Recombinant Human inputs and products Erythropoietin solution in vials, ampoules and syringes (2,000 IU / MG X 1 mL; 3,000 IU / MG X 1ml; 4,000 IU / MG X 1 ml, 10,000 IU / MG x 1 ml, 36,000 IU / MG X 1ml) and Interferon Alfa ampoules Bottle lyophilized powders (1.0000 IU / ml, 3,000 IU / ml, 5,000 IU / ml, 9,000 IU / ml) .The products are produced by the Chinese company Shenyang Sunshine Pharmaceutical Co. Ltd. and were suspended after being cited irregularities during inspection for verification of Good Manufacturing Practices.
American Health Packaging Initiates Class II Recall of Lamivudine and Zidovudine Tablets Due to Failed Dissolution Specifications
Government exempts AIDS drugs from customs duty
US FDA approves sale of Strides Arcolab`s HIV treatment drug