Formulation & Inhalation support
When a compound of interest eventually is selected and characterized, it is time to explore the formulation design space. Several important features have a strong solid state connection and e.g. the selection of suitable excipients can be facilitated by using the Excipient Compatibility Screening support.
Frequently the manufactured raw material exhibit suboptimal bioavailability and/or a batch to batch variation in dissolution. For instance, in order to improve characteristics it is common to apply milling or even micronization processing. This is however a violent process and it is important to perform valid Particle Characterization of the powder before and after processing for a comprehensive understanding.
Characterisation and understanding of solid state properties and stability of multi-component amorphous phases produced by freeze- or spray drying demands specific analytical skills and customers invite Adroit Science to provide related educational seminars but also to support them during product development. A thorough understanding of the interplay between the manufacturing process and the solid state quality/stability of the products is especially critical within Freeze- and spray drying area.
Special challenges are always encountered when aiming for the inhaled rout. In particular when using powder inhalation it is of utmost importance with a comprehensive understanding of both inherent particle properties and consequences of particle size reduction techniques etc. Hence, it is vital to make use of relevant Dry Powder Inhalation Support that can be provided by our scientist.
Oral Solid Dosage forms (tablets and capsules) are the most common products types within pharmaceutical industry but in spite of their long history of production not even direct compressed IR tablets can be regarded as completely straight forward to develop with regard to safety, robustness and efficacy. Adroit Science provide support and in-depth characterization expertise related to development and stability assessment of all types of oral solid dosage forms.
No matter how accurate and percipient the pure solid state analysis are there will always be cases where there is a need to verify or disprove interpretations, and/or the relevance of specific results, using alternative approaches. Within the area of Analytical Separation Services a kit of very useful analytical technologies are available providing not only traditional analytical services but also necessary complementary solid state investigations e.g. verifications of salt stoichiometry.
Once the primary investigations, selections and preformulation work are performed the development for launch starts and interactions with authorities become important challenge. One important aspects of the documentation is the regulatory guidelines related to the solid state area. In order to increase the success rate and avoid unnecessary delays it is strongly recommended to make use of relevant Regulatory Support.