FORMULATION DEVELOPMENT SERVICES

FORMULATION DEVELOPMENT SERVICES

Pre-formulation Development

At Stegram Pharmaceuticals, we recognize the importance of our clients’ requirement to develop robust and compliant formulations. Starting with comprehensive pre-formulation services, At Stegram Pharmaceuticals helps its customers to determine optimal dosage forms they can use for preclinical or clinical applications. With our analytical development services supporting our preformulation work, Stegram Pharmaceuticals can perform full physico-chemical characterization using modern analytical techniquesin-house for rapid turnaround times.

At Stegram Pharmaceuticals evaluates and determines a variety of parameters to help you arrive at the right formulation using your API.

These may include:

  • Solubility of API in different media and solvents
  • Excipient compatibility studies
  • Dissolution of the active pharmaceutical ingredient (API)
  • Accelerated Stability Services under various conditions
  • Solid state analysis (polymorphs, particle size, particle shape etc.)

At Stegram Pharmaceuticals, we recognize the importance of our clients’ requirement to develop robust and compliant formulations. Starting with comprehensive pre-formulation services, Stegram Pharmaceuticals helps its customers to determine optimal dosage forms they can use for preclinical or clinical applications. With our analytical development services supporting our preformulation work, At Stegram Pharmaceuticals can perform full physico-chemical characterization using modern analytical techniquesin-house for rapid turnaround times.

At Stegram Pharmaceuticals evaluates and determines a variety of parameters to help you arrive at the right formulation using your API.

These may include:

  • Solubility of API in different media and solvents
  • Excipient compatibility studies
  • Dissolution of the active pharmaceutical ingredient (API)
  • Accelerated Stability Services under various conditions
  • Solid state analysis (polymorphs, particle size, particle shape etc.)
Formulation Development

Stegram Pharmaceuticals has the right equipment, facilities and highly dedicated formulation development specialists to help you arrive at the optimal dosage form for your API and application. We ensure any forms we develop are scalable, compliant and commercializable for our customers.

We can formulate a wide range of sterile and non-sterile dosage forms including:

  • Oral Immediate Release – Solutions, Emulsions, Suspensions and Capsules
  • Oral Controlled Release – Matrix based release, Multi-particulate systems, Polymer Film Coatings, pH Dependent Release
  • Topical and Transdermals – Gels, Creams, Ointments, Lotions
  • Sterile Liquids – Solutions, Suspensions, Colloids, Liposomes
  • Powders – Sterile and non-sterile powder filling
  • Sterile liquid dosage formulations (ophthalmic, oral, nasal)
  • Injectable drugs (intravenous, and intramuscular, subcutaneous injectables)
  • Lyophilized formulations
Formulation Services and Capabilities
  • Formulation development for new chemical entities (NCE)
  • Optimization of existing formulations
  • Product/Process Optimization
  • Novel formulations for improved delivery of existing dosage forms
  • Controlled release and sustained release formulations
  • Self-emulsifying drug delivery systems
  • Colloidal drug delivery systems
  • Sub-micron and nano-emulsions
  • Feasibilit
  • Excipient Compatibility selection and optimization
  • Physico-Chemical Testing
  • Process Scale-Up
  • y Studies
  • Technology Transfers
  • Batch manufacture

Our expert formulation development group overcomes difficult formulation challenges in a rapid and cost effective manner. Our formulation development services can be utilized independently or with our fully integrated services to accelerate your drug development program.

Liposomal Formulation

Liposomal Formulation

Stegram Pharmaceuticals  offers its customers more than 10 years of experience using complex liposomal formulations with small molecules, proteins and peptides. Our experience with liposomes includes:

  • Aseptic or terminally sterilized (TS)
  • Extrusion manufacturing
  • Batch Process manufacturing
  • Lyophilization cycle optimization
  • Existing formulation enhancements

Stegram Pharmaceuticals  has extensively used both Synthetic and Natural Liposomes. With capabilities to extract and formulate naturally occurring liposomes (bilosomes), Dalton is your ideal partner for developing liposomal products.

Stegram Pharmaceuticals  offers its customers more than 10 years of experience using complex liposomal formulations with small molecules, proteins and peptides. Our experience with liposomes includes:

  • Aseptic or terminally sterilized (TS)
  • Extrusion manufacturing
  • Batch Process manufacturing
  • Lyophilization cycle optimization
  • Existing formulation enhancements

Stegram Pharmaceuticals  has extensively used both Synthetic and Natural Liposomes. With capabilities to extract and formulate naturally occurring liposomes (bilosomes), Dalton is your ideal partner for developing liposomal products.

Sterile Formulation Development

Sterile Formulation Development

Stegarm Pharmaceuticals integrated services offering includes sterile product formulation development. From the most simple sterile liquid formulation to complex liposomal or lyophilized formats, Dalton’s formulation team can develop a robust formulation meeting your needs. Our experienced formulators develop your formulation in our R&D lab with cGMP requirements in mind. Our formulation department is fully supported by our in-house analytical team who ensure our formulators have the best data and the shortest turn-around times allowing rapid decision making in the formulation development process.

Our formulation development team are experts in:

  • Sterile liquid formulations
  • Sterile liposomal formulations

  • Excipient selection and compatibility

  • Formulation scale up

  • Lyophilized product development

  • Sterile powder formulations

Let Stegram Pharmaceuticals be your sterile formulation experts.

Stegram Pharmaceuticals integrated services offering includes sterile product formulation development. From the most simple sterile liquid formulation to complex liposomal or lyophilized formats, Dalton’s formulation team can develop a robust formulation meeting your needs. Our experienced formulators develop your formulation in our R&D lab with cGMP requirements in mind. Our formulation department is fully supported by our in-house analytical team who ensure our formulators have the best data and the shortest turn-around times allowing rapid decision making in the formulation development process.

Our formulation development team are experts in:

  • Sterile liquid formulations
  • Sterile liposomal formulations

  • Excipient selection and compatibility

  • Formulation scale up

  • Lyophilized product development

  • Sterile powder formulations

Let Stegram Pharmaceuticals be your sterile formulation experts.

copyright© 2022 stegrampharma.co.uk