Excipients Formulation Development Support

Excipients Formulation Development Support
Product Description


Excipients play a central role in the drug development process, in the formulation of stable dosage forms and in their administration. Though excipients were at one time assumed to be “inactive” ingredients, it is now understood that excipients can have an important impact on the pharmaceutical and chemical performance of a drug product formulation. It’s therefore important to identify unknown and control Functionality Related Characteristics (FRC) of excipient materials, to manage their effects on pharmacodynamics and pharmacokinetics and achieve safe, robust and stable pharmaceutical products.
Excipia can help companies with their formulation development.

  • to identify critical (combinations of) excipients and Functionality Related Characteristics (FRCs) in formulations,
  • investigate formulation and excipient batch-to-batch variability,
  • troubleshoot underperforming pharmaceutical formulations,
  • select specific excipient batches, grades, or suppliers,
  • set in-house excipient specifications for customized pharmaceutical product properties.

In addition, due to the unique combination with a pharmaceutical development and dissolution testing services within Avivia, Excipia can provide comprehensive insight into various product features, such as detailed release performance, and apply and test new insights with small-scale development batches.

Read more: https://www.excipia.eu/formulation-development/

Contact us: https://www.excipia.eu/contact/


Avivia BV

  • NL
  • 2017
    On CPHI since
  • 1 - 24
    Employees
Company types
Academic/Research
Consultancy
Contract Research Organisation (CRO)
Contract Service
Pharmaceutical company
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)
Specifications

Avivia BV

  • NL
  • 2017
    On CPHI since
  • 1 - 24
    Employees
Company types
Academic/Research
Consultancy
Contract Research Organisation (CRO)
Contract Service
Pharmaceutical company
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)

More Products from Avivia BV (10)

  • Excipia       Experts in excipient analysis, characterization and deformulation / reverse engineering

    Product Excipia Experts in excipient analysis, characterization and deformulation / reverse engineering

    Excipients can have an important impact on the manufacturability and pharmaceutical performance of a formulation. It’s therefore important to identify and control functionality related characteristics (FRCs) of excipient materials in order to achieve safe, robust and stable products. Expe...
  • Pharmaceutical R&D Services

    Product Pharmaceutical R&D Services

    Having decades of hands-on experience on a wide range of (complex) technologies and a many different types of products, our Pharmaceutical experts are able to fully execute and/or support the development of any finished dosage form, formula or process, as well as the transfer and scale-up of a deve...
  • Dissolution Testing  -  R&D services

    Product Dissolution Testing - R&D services

    For us dissolution testing is never a routine test but an essential tool in pharmaceutical formulation development to:

    • evaluate the physicochemical properties of drug candidates to select the most appropriate solid form for further development (pre-formulation)
    • compare pro...
  • Analytical research & development

    Product Analytical research & development

    Our analytical experts know what it takes to bring a pharmaceutical product to the market, from discovery, feasibility to GMP. Having worked with more than 100 unique molecules and even more formulations, we may state that we have faced the most difficult CMC challenges that are involved.
    ...
  • Excipient Quality Testing and Selection Services

    Product Excipient Quality Testing and Selection Services

    Excipient testing, composition and variabilityExcipients are either natural / naturally derived or synthetic / semi-synthetic. In all cases the exipients are obtained through chemical processing of a raw material source that usually has an animal, vegetable or mineral origin.

    ...
  • Pharmaceutical Deformulation / Reverse Engineering

    Product Pharmaceutical Deformulation / Reverse Engineering

    Our experience in excipient characterization and deformulation of pharmaceutical formulations gives us the opportunity not only to identify and quantify individual excipients in a complex pharmaceutical formulation, but often also confirm the excipient grade, excipient quality and sometimes even the excipi...
  • Life cycle management of branded products

    Product Life cycle management of branded products

    Our ‘life cycle management’ development services are focused on maximizing the value of your drug during its product life cycle. Typically, we are asked by pharmaceutical and biotech companies to develop new product formulations of branded drugs to anticipate on patent expiries, generic competition...
  • Complex formulation/CMC development of NCEs

    Product Complex formulation/CMC development of NCEs

    Avivia is known amongst the drug development community for being able to deliver successful solutions for complex and challenging formulation and CMC development projects. Typically, pharmaceutical companies and smaller drug development firms approach us with development programs that have derailed...
  • Value-added generic development

    Product Value-added generic development

    Avivia offers full product development services to generic drug companies and specialty pharma focused on the development of new improved versions (value-added generics or generic plus) of established drug products.
    Although in general the overall aim of value-added generic development projects is focu...
  • Complex drug formulation

    Product Complex drug formulation

    We like to get involved right from the start of a development project and work closely together with our clients and partners on transforming the idea into a product with a solid and commercially viable target product profile (TPP). We set the bar high but always work step by step with a clear focus on...

Avivia BV resources (1)

  • Brochure Avivia Services

    Brochure Avivia independent pharmaceutical development services.
    Established in 2005, Avivia is a specialized pharmaceutical development company engaged in CRO service activities, drug repositioning, repurposing and reformulation. Over the past fifteen years, the company has built a solid reputation recognized for its R&D flexibility and ‘out-of-the-box’ approach towards complex and challenging analytical and pharmaceutical development projects. Today, we are the preferred partner for many big pharma, specialty pharma, generic drug companies, academic centra, and smaller drug development firms.