Pre-formulation studies

The use of tested and flexible protocols allow our team of expert chemists and analysts to provide studies tailored to client requirements.

All programs can also be carried out on highly potent (HPAPI) and cytotoxic products up to OEB4.

API-EXCIPIENT COMPATIBILITY: Find possible interactions between your API and a list of excipients.

 

 

DISSOLUTION TESTING: Determine the solubility profile of your drug.

 

 

 

 

   

   

PATENT SUPPORT: Protect your invention and avoid infringing others patents.

 

 

 

STABILITY STUDIES: To ensure quality and performance during storage.

 

 

 

IN VITRO BIOEQUIVALENCE: Drug performance level compared to a reference.

 

 

 

 

   

SOLID FORM SELECTION: Find your best drug form candidate for development.

   

API-excipient compatibility

In addition to API, a pharmaceutical dosage form contains excipients which can affect the chemical, physical and therapeutical properties, product stability and may even cause a change in the API polymorphic form. Estimation of API-excipient interactions is a crucial step in preformulation studies of drug development to achieve a robust and effective formulation of dosage forms that make administration easier, improve patient compliance, promote release and bioavailability of the drug and increase its shelf life.

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Stability studies

The thermodynamic relationships between polymorphic forms is crucial and must be established carefully, because as drug crystallises from different conditions the kinetically favoured metastable polymorph appears first. However, this metastable polymorph may undergo environmental induced transformation to produce thermodynamically stable form at its own expense, affecting important properties such as the ability to process and/or manufacture the drug substance and the drug product, as well as on drug product stabi

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Patent support

Different types of protection strategies may be obtained around a drug product. The pharmaceutical industry has moved to accelerate drug development process and to adopt at the same time different strategies to extend the life time of the patent monopoly to provide the economic incentives and utilizing it for drug discovery and development.   How can we help you? Evaluation of the patentability of new forms and processes Avoid infringing other inventors’ patents Avoid duplicating research and de

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Dissolution testing

Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution or solubilisation of the drug under physiological conditions, and the permeability across the gastrointestinal tract. Because of the critical nature of the first two of these steps, in vitro dissolution may be relevant to the prediction of in vivo performance.   How can we help you? Assess the lot-to-lot quality of a drug product Guide development of new

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In vitro bioequivalence

For approval of generic drug products, bioequivalence testing   is considered as a surrogate for clinical evaluation of the therapeutic   equivalence of drug products based on the fundamental bioequivalence assumption that when two drug products are equivalent in bioavailability, they will reach the same therapeutic effect. By performing in vitro studies we can have a control over the system. It also allows to mimic the biological conditions. In vitro studies reduce the cost and number of trials

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