Formulation R & D

Optimus generics R&D pipeline is focused on developing a comprehensive portfolio of complex & niche products that address unmet patient needs. We’ve continuously executed dossier filings and received approvals from across the globe including the USA, Europe & India. Our formulation R&D centre is DSIR approved, built as per global standards with dedicated infrastructure and technology to deliver high-quality products.

Formulation Development

Formulation Development is the core competency of Optimus Pharma, and we routinely carry out the development of Generic formulations, Specialty and novel formulations, Consumer and Over-The-Counter (OTC) formulations with desired sensorial attributes, excipient application studies and placebo development.

Product Strategy
Development

Product development at Optimus begins with a product development strategy. Desired product attributes are identified, and prototype formulations are developed to meet the desired product attributes. Critical process parameters (CPP) are identified, and process optimization studies are carried out based on Quality by Design (QbD) principles. Based on the formula and process optimization studies, the final composition and manufacturing process is recommended for biostudy and scale-up.

Dosage Forms

Topiocal Products

Ointments, creams and gel preparations

Tablets

Multilayer tablets, compression-coated tablets and inlay tablets

Capsule

Pellets of immdediate-release, sustained-release and delyed-release

Liquid Orals

Syrups and suspensions

Analytical Development

  • Process Capabilities
  • Services
  • Capabilities

Process Capabilities

  • High Shear Wet granulation (High Shear and Top spray)
  • Roller Compaction
  • Fluid bed granulation
  • Direct compression
  • Fluid bed drying
  • Wurster coating (palletization)
  • Tablet compression
  • Tablet coating
  • Encapsulation (Pellets, powder and granules)
  • Bottle packing
  • Blister packing
  • Tube filling (for Semi solids)
  • MUPS
  • Pelletization (Extrusion-Spheronization, Wurster-Processer)
  • Unit Dose Packaging (Blisters/Strips, bottles)
  • Bottle and Blister packaging lines

Services

  • Analytical method development for drug product
  • Method validation for drug product to support NDA/ANDA applications
  • Stability studies to support development & regulatory fillings of drug product
  • Solid state characterization for drug product.
  • Cleaning methods for drug products
  • Method transfers.

Capabilities

  • HPLCs (UV and PDA detectors)
  • UV-Visible Spectrophotometry
  • Infrared spectroscopy
  • Gas Chromatography
  • Water Activity and Moisture Quantification
  • Dissolution (USP I and II)

Research Center

We are proud of our research accomplishments and we look forward to many more R&D challenges in the future, with a great level of confidence and enthusiasm.