Services – Formulation Development

Formulation Development

Enem Nostrum’s 3000 sq. feet Formulation Research & development laboratory is based at Andheri, Mumbai located at less than 10 minutes drive from Mumbai International Airport.

Enem Nostrum provides robust Pharamceutical Formulation Development Services to our clients. Our two decades of experience in pharmaceutical development along with modern Research and Development laboratory are ideally suited to meet all of your formulation development needs. Enem Nostrum has expertise in development of the following dosage forms,

  • Conventional Tablets
  • Conventional capsules
  • Enteric coated tablets
  • Modified release formulations
  • Liquid and semi-solid formulations
  • Topical preparations
  • Sublingual and Buccal formulation
  • Creams, Ointments and Gels

Our Formulation laboratory is fully equipped with:

Enem Nostrum has state-of-the-art formulation development facility with modern equipment and experienced formulation scientists. Enem Nostrum is committed to provide pharmaceutical products and services of the highest quality standards through continual improvement and in compliance to the applicable regulatory requirements. To maximize efficiency, save resources and increase customer satisfaction, Quality by Design (QbD) approach is an integral part of the product development.

All the systems are supported with detailed standard operating procedures and specific protocols, which are authorized for use by Quality Assurance department. Enem advantages includes development of high quality drug products within short period of time maintaining the client confidentiality as well as Protection of intellectual property. Enem’s quick access to global market, has great advantage for our clients.

Enem provides support not only during the development of the formulations but has expertise to extend its support during scale up and technology transfer, product submissions and commercial manufacturing. Enem has already developed several no-infringing, bioequivalent products for its clients which were submitted to USFDA and has received approvals and subsequently commercialized for US market.

  • Infrastructure encompassing a wide range of Novel drug delivery systems, Solid, Semi-solid and Liquid Oral dosage forms
  • Specializes in handling controlled Substances products
  • Scientific talent pool with multifaceted expertise

Key Equipment and Instruments

Our laboratory is well-equipped to handle following processes:

  • Direct compression technology
  • High shear wet granulation
  • Fluid bed processing (granulation, drying, coating)
  • Dry granulation (roller compaction, slugging)
  • Extrusion spheronization
  • Perforated pan tablet coating by using Autocoaters
  • Capsule filling (powder, granules, pellets)
  • Spray drying

At Enem Nostrum our new product development program generally includes literature surveys, pre-formulation studies, compatibility studies, analytical method development and validation, formulation development and optimization, formal stability studies, and manufacturing process development according to international guidelines.

Technology / Expertise

  • Novel drug delivery system with expertise in development of modified release formulations and immediate release formulations for drugs with low bioavailability.
  • Patented Proprietary hydrogel matrices, as well as non-polymeric release rate controllers for modified release products
  • Pellet formulations
  • Topical drug delivery systems
  • Micronization of drugs using Air jet Mill to evaluate particle size effect
  • Multi-layered tablets
  • Cosmetic and Personal care products
  • Formulating poorly soluble drugs
  • Spray drying and spray congealing
  • Characterization of Innovator products (RLD) for ANDA development
  • Drug excipient compatibility studies
  • Powder and film coatings