Discovering a potent and highly selective API is of course only part of the story of creating a new medicine. Careful consideration of the appropriate dosage form for the patient is essential for effective treatment. Of course, different dosage forms present a wide range of technical challenges with product solubility and long term stability paramount to the ultimate success of the therapeutic treatment. Specific pharmaceutical formulation challenges include investigating the dissolution process, particle size, drug and excipient phase behaviour, along with the effects of polymorphism, solubility and oxidation among others.
Many patients suffering from chronic conditions such as diabetes, schizophrenia and acromegaly are required to administer treatments subcutaneously or intramuscularly using injections.
Whilst the efficacy of these treatments has been well documented, the absorption mechanisms, the impact of different formulations and their delivery, is not yet fully understood.
The ability to modulate drug delivery at therapeutically effective doses over a sustained period of time, in vivo, is very challenging. In the case of poorly water-soluble drugs this requires a carefully designed matrix to manage and maintain their controlled release.
Lipid cubic phase carriers offer an effective way to transport both small molecules and larger proteins through oral and parenteral routes (those outside of the digestive tract), as well as local delivery via subcutaneous and intramuscular routes. Complex interactions between the drug and the lipid matrix govern the release profile; for hydrophilic drugs, release can be very fast. The carriers can also be compromised by naturally occurring lipolytic enzymes which act to break down the lipid microstructure.Read more...
Drug products in the pharmaceutical industry are commonly prepared in the form of discrete multi-particulate units. Bead products are a vehicle used in the development of controlled release drugs and are prepared by coating an inert spherical core with multiple layers, including that of the active ingredient. Components in each applied layer can have a significant impact on how the drug will be released and porosity of the layers is a critical feature related to observed dissolution behaviour. However accurate and highly resolved measurement of the physical integrity of these layers is a significant challenge in the development of advanced multi-particulate dosage forms.Read more...
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