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During drug product development, stability studies are used to ensure that the safety and efficacy of a product are not affected during storage. Any change in the dissolution performance of a product must be investigated, as this may indicate a change in the bioavailability. In this study, three different griseofulvin formulations were prepared containing microcrystalline cellulose (MCC) with either mannitol, lactose monohydrate, or dibasic calcium phosphate anhydrous (DCPA). The tensile strength, porosity, contact angle, disintegration time, and dissolution rate were measured after storage under five different accelerated temperature and humidity conditions for 1, 2, and 4 weeks. The dissolution rate was found to decrease after storage for all three batches, with the change in dissolution rate strongly correlating with the storage humidity. The changes in physical properties of each formulation were found to relate to either the premature swelling (MCC/DCPA, MCC/lactose) or dissolution (MCC/mannitol) of particles during storage. These results are also discussed with consideration of the performance- and stability-controlling mechanisms of placebo tablets of the same formulations [1, 2].
|Number of pages||10|
|Journal||International Journal of Pharmaceutics|
|Early online date||6 Dec 2022|
|Publication status||Published - 25 Jan 2023|
- physical stability
- accelerated stability
- physical properties of tablets
- solid oral dosage forms
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- 1 Finished
Pressure-dependent In-Situ Monitoring of Granular Materials
Florence, A., Halbert, G., Markl, D., McArthur, S., Nordon, A. & Oswald, I.
EPSRC (Engineering and Physical Sciences Research Council)
1/01/19 → 31/12/22
Physical stability of pharmaceutical tablets: from mechanistic understanding to prediction of long-term stabilityAuthor: Maclean, N., 19 Aug 2022
Supervisor: Khadra, I. (Supervisor) & Markl, D. (Supervisor)
Student thesis: Doctoral Thesis