Research & Development

New Drug Delivery Systems

NDDS department is supported by a group of scientist having expertise in the field of Injectable product development. Our multidisciplinary teams use their combined expertise to make sure the dosage forms we devise exactly the right delivery profile, and are robust from a manufacturability standpoint at lab, pilot, and commercial scales.

Capabilities

BSV's NDDS has capabilities to develop complex generic and innovative specialty pharmaceutical / bio-pharmaceutical products mainly in injectable and other dosage forms like ophthalmic and modified release oral dosage forms. BSV would be amongst the very few companies globally having expertise in developing products across various drug delivery systems, including liposomes, lipid complexes, emulsions, microspheres, implants and cyclodextrines, from research to commercialisation

The "complex generics (super generics) " program is targeted on developing those generic drug products that are:

  • - Difficult to develop for technical and scientific reasons, including molecules with solubility, stability, characterization and synthesis complexities
  • - Niche area of use
  • - Complicated manufacturing
  • - Complicated bio-equivalency or clinical studies
  • - Potential to provide value to patients and prescribers, in terms of cost effectiveness, patient compliance by reducing frequency of dose administration.

"Specialty Pharmaceuticals" includes novel and innovative new formulation/products of existing drugs that are developed to address certain unmet clinical and/or market needs of existing drugs with unfavorable adverse effects profile, or with challenging formulation/processing issues. Value-add to patients and prescribers include access to cost effective, safer, compliance/ease of use, and in some cases more efficacious new/improved products.

BSV has a broad portfolio of products under development, with formulations including solutions, suspension, lyophilized, emulsions, liposomes, micelles and lipid complexes. NDDS pipeline includes small molecules with solubility and stability challenges, as well as difficult to produce and characterize polypeptides. The Company has a comprehensive infrastructure for the development of its products in its state of the art R&D facilities in Thane, Maharashtra, with the capability to handle potent and cytotoxic molecules.

NDDS Department has developed non-infringing patentable technologies which has lead BSV to developed following platform technologies for parenteral products

  • Emulsion & Nanoemulsion
  • Liposomes:-Pegylated & Non-pegylated
  • Lipid complexes
  • Depot Injection:- Microspheres, Implants
  • Nanoparticles
  • Lyophilised products
  • Micellar systems
  • Topical Gels
  • Ophthalmic emulsions

Formulation development

  • Pre-formulation
  • Formulation development
  • Analytical development
  • Stability studies
  • Preclinical development
  • Clinical development

Infrastructure

BSV's NDDS department develops sterile injectable and ophthalmic pharmaceutical products in its state of the art R&D laboratories, located in Thane.

  • Laboratories include compounding, filling, sterilization, and cGMP compliant analytical and stability R&D.
  • The formulations under development include solutions, suspensions, lyophilized, liposomes, emulsion, micelle and lipid complex.
  • Presentations include ampoules & vials
  • Molecules under development include small molecules and polypeptides.

The scope of R&D activities include analytical characterization, method development and validation, pre-formulation, formulation and manufacturing process development and optimization, as well as stability testing under ICH and cGMP guidelines.

The product development efforts at BSV's NDDS are supported by complementary functional areas, including Project Management, Quality Assurance, Regulatory Operations & Affairs, Pre-clinical and Clinical expertise, Commercial Supply Operations, as well as a comprehensive Library, administrative, HR and IT infrastructure.

NDDS department is equipped with specialized equipment to carry the development of formulation and analysis of :

A. High pressure homogenizer
B. High speed emulsifiers
C. Lyophiliser
D. Spray dryer
E. Supercritical Fluid extractor (SAS technology)
F. Extruders

Formulation development is well supported by in-house analytical infrastructure and includes sophistaced equipments such as HPLC with PDA/RI/Fluoresces/ELSD detectors, Head space gas chromatography and Particles size analyzer, to name a few