Journal of Bioequivalence & Bioavailability

Les Laboratoires Medis, Nabeul, Tunisia

Biography

Mahmoud AlSwisi currently works at the Pharmaceuicals, PharmaConsult. Mahmoud does research in Nanotechnology, Pharmacy and Clinical Trials. Their current project is 'BCS biowaiver'. he is working on.His research subjects are Drug Formulation and  Pharmaceutics and Pharmaceutical Technology,

Publications

• Research Article   
  Biopharmaceutics Classification System (BCS) Based Biowaiver Studies of Lenalidomide Capsules (25 mg) – An Alternative to In vivo Bioequivalence Studies for Generic Oncology Drug Products
  Author(s): AlSwisi Mahmoud*, Boujbel Lassaad and Boujbel Mohamed Amine
  
  Lenalidomide, commercialized as Revlimid®, is an immunomodulatory drug, approved as a therapy for Multiple Myeloma and deletion 5q Myelodysplastic syndromes. This molecule shows a promising therapeutic potential in other hematologic malignancies. According to the European Medicines Agency (EMA), lenalidomide is considered as a fully absorbed drug substance, however, there is no sufficient data on solubility that enables its BCS classification. Therefore, as per the International Council for Harmonization (ICH) guideline, a solubility study has been done by Les Laboratoires Medis to prove that lenalidomide is a highly soluble compound. This demonstration requires the investigation in different buffer solutions within the range of pH 1- 6.8 (including pKa) at 37 ± 1°C and we have proceeded with a nominal concentration (1.0 mg/ml) which repr.. View more»
  

  DOI: 10.35248/0975-0851.19.11.386

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