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Case Studies 2017-03-14T13:21:55+00:00

Case Studies

Second Opinion on Phase III CTA

Background

The client had purchased an API development project at the stage when positive read-outs from phase II clinical studies existed. During the further development work aiming for phase III the client observed that the “purchased documentation” on the API solid state characterization work, e.g. the polymorph situation, was both complex and unclear. Read more >>>

Generation of new market opportunities for an established API

Background

A customer desired to investigate the possibilities to improve the bioavailability for an already marketed and established oral product. Read more >>>

Screening of Incompatibility between Drug and Excipient

Background

An important step in the design and development of optimal formulations for a pharmaceutical product is the selection of excipients to be used together with the active ingredient. Especially for low dose tablets there will be a significant number of points of interaction between the API and the different excipients. Hence, it is vital to select excipients that not only fulfil manufacturing and product performance demands but also to avoid any kind of incompatibility. Read more >>>

Removal of Residual Solvent after Manufacturing

Background

Manufacturing of substances normally involves the usage of different solvents from which the active ingredient is forced to precipitate or even crystallize. After isolation of the solid material it is of vital importance, both from a regulatory and quality/stability point of view, to remove the residual solvent. However, sometimes it just happens… the solvent molecules resist all reasonable temperature and vacuum combinations applied. Read more >>>

Determination of Particle Size inside a Tablet

Background

Suddenly the question will occur: What is the actual particle size of your drug component inside the formulated tablet, after all processing steps?

To measure particle sizes of the individual ingoing components separately before formulation is a fairly straightforward process. Once entered into the manufacturing process and mixed with all necessary excipients, the challenges increases dramatically. It is far from trivial to deduce the modified (from different applied processing steps) particle sizes – not to mention to be able to separate the contribution from the other ingoing components. Read more >>>

Screening of API batches related to a blend uniformity issue

Background

Dry powder inhalation (DPI) formulation are one of the most challenging process step to be performed where even small differences in mixing behaviour may induce big differences in aerosolisation properties.

In the present case apparently equally good manufacturing batches of an API behaved significantly different in the mixing processing step with sever issues for the production of DPIs as a consequence. Read more >>>

Identification of crystalline form of active ingredient in low strength topical cream

Background

A cream for topical application is formulated using the active ingredient in a concentration of 1 mg/g. The formulation is manufactured using the anhydrous form of the ingredient. The cream contains e.g. water/propylene glycol mixture while it could be expected that the anhydrate could transform to the, in water, thermodynamically more stable monohydrate. Hence it is important to understand how to avoid/minimize this transformation. Read more >>>

Dissolution of inhalation powders

Background

Dissolution of inhalation formulations is interesting to study, both from a quality control perspective and as a possibility to correlate in-vitro data with in-vivo performance. Difference in dissolution rate between eg substances, particle sizes and formulations can be revealed. Read more >>>

Characterisation of sugars for the food industry

Background

The food industry are using a broad range of different sugars with various properties depending on purpose and just as for pharmaceutical APIs and excipients it is of vital importance that a robust quality of food ingredients can be produced. In this case a customer desired to investigate the hydration and dehydration of a specific sugar and the related influence on polymorphism. Read more >>>