Publications on gels creams and semi solid forms
Gels, crèmes, formes semi-solides : de leur développement à leur enregistrement.
[Gels, creams, semi-solid forms: from their development to their registration]
E. Beyssac, V. Boudy, E. Dauphin-Chanard, S. Delehouzé, L. Frances, B. Gos, C. Lacaze, V. Laffineur, A. Mestres, I. Ribeiro Dos Santos, X. Thomas and N. Zeng
STP Pharma Pratiques – September October 2018 – 28(5) 181-250 – ISSN 1157-1497
The SFSTP commission on topical dosage forms published an article reviewing all the steps for their development to registration.
Interestingly this article is both in French and English languages.
Introduction
I Definition of a semi-solid
II Tests and studies applicable in evaluation of semi-solid forms from development up to the phase of routine use
2.1 Regulatory requirements
2.2 Relevant tests in development
2.2.1 Conventional characterization tests
2.2.2 Characterization tests specified to evaluate performance of the formulation
2.2.3 Additional characterization tests specified to evaluate performance of the formulation
III QbD approach related to the formulation
3.1 Different elements of the QbD
3.2 When to set up QbD ?
3.3 Definition of QTPP
3.4 CQAs toward evaluation of risks of process
3.5 Example of CMAs studied in case of a semi-solid formulation
3.6 Example of CPPs studied in case of a semi-solid formulation
Conclusion
IV Conclusions and perspectives
