Services – Formulation Development Backup

Formulation Development

Enem Nostrum’s 3000 sq. feet Formulation Research &development laboratory is based at Andheri, Mumbai located at less than 10 minute 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 art formulation development facility with modern equipment and experienced formulation scientists. Enem Nostrum is committed to provide Pharmaceutical products and Services of 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 reveived 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.

V-Blender with Intensifier Bar (Patterson Kelley Co. USA)

0.5 quart to 16 quart (about 0.5 Liters to 15 Liters working capacity) V-Blenders equipped with high-speed intensifier bars (or lump breakers) along with spray mechanism for liquid addition.

  • Breaking of agglomerates in the charge material facilitating precise blending uniformity specifically for low dose drugs.
  • Ability to accomplish dry as well as wet mixing.
  • Suitability for mixing of cohesive powders, fine as well as course particle compositions
Dry granulation with Roller Compaction

Roller compactor with an Output (Kgs / Hr): 2 to 5. Improves powder flow properties, avoid wet granulation induced degradation, improve product stability, prevent segregation and reduce bulk volume.

Wet Granulation with High Shear Mixer Granulators

Rapid Mixer Granulator capacity: 10 Liters

  • Main Impeller unique design maximizes micro-mixing of ingredients by effecting optimal diffusion, convection & shears irrespective of varying bulk densities, both during dry & wet mixing.
  • Accurate inference for end-point detection with Amperage meter
  • Unique Design of Chopper: Ensure effective de-lumping of oversized agglomerates distribution of binder fluid and ideal compaction of granules.
High speed Tablet Press

Sejong GRC-Series 15 Station Pilot Press

  • Production range from 15,000 to 80,000 tablets per hour.
  • Presses are equipped with modern, large touch screen interface
  • Force feeders, Mechanical Constant Amount Feeder and gravity feeders
  • Automatic Weight Control (A.W.C) system to enhance R&D development
Bilayer Rotary tablet Press

9 stations for production of double-layer and mono layer tablets

Auto coaters for Tablet coating

Autocoaters, Available in Pan sizes with capacities: 200 g to 5 Kg

  • Fully automatic film & sugar coating process by PLC Controls
  • Dehumidified air supplied from a Bry-Air for moisture sensitive coatings
  • Perforated Pan having variable speed through AC frequency Drive
Buchi Spray dryer and congealer
  • A bench-top system for quick and easy drying of aqueous and organic solutions and suspensions
  • Spray gas Compressed air or nitrogen for oxidation sensitive products
  • Inert Loop allows safe working with organic solvents
  • Spray chilling accessory to enable spray congealing of hot melts of waxes, polymers and fats with a melting point of maximum 70 °C
  • Useful technology for solubilizing poorly soluble drugs, microencapsulation of flavors or any drug or excipient
Extrusion Spheronization
  • Cone extruder is widely used for making pellets of different sizes. Different cone meshes (0.5, 0.8 and 1.0 mm)
  • Different chequered plates (2mm and 3.00mm)
Stability Cabinets

Mack Pharma Tech Stability chambers

  • ICH Stability cabinets to evaluate product stability based on real-time accelerated and long-term by controlling temperature and relative humidity
  • 25°C & 60%RH, 30°C & 65%RH, 40°C & 75%RH, 30°C & 75%RH
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
Work done at Enem Nostrum has resulted in several patents
US 6946146 B2 Coating For A Sustained Release Pharmaceutical Composition
US 8545882 B2 Control Release Formulation Containing A Hydrophobic Material As The Sustained Release Agent
US 7052706 B2 Control Release Formulation Containing A Hydrophobic Material As The Sustained Release Agent
US 8507000 B2 Controlled Release Formulation Of Erythromycin Derivatives
US 6437000 B1 Controlled Release Oral Dosage For Suitable For Oral Administration
US6475493B1 Controlled Release Pellet Formulation
US6635680B2 Controlled Release Pellet Formulation
US6638522B1 Microemulsion Concentrate Composition Of Cyclosporin
US7897179B2 Pharmaceutical Composition Containing Water Soluble Drug
US8906419B2 Pharmaceutical Composition Containing Water Soluble Drug
US7179486B1 Process For Preparing Sustained Release Tablets
US6436430B1 Self-emulsifying Compositions For Drugs Poorly Soluble In Water
US6416786B1 Sustained Release Tablet Containing Hydrocolloid And Cellulose Ether