Formulation and Evaluation of Micro Balloons of Domperidone
The present study on the manufacturing of Microballons of Domperidone elaborates various steps taken during the development and manufacturing of microballoons keeping in constant knowledge of quality by design guidelines. The importance of target product profile and critical quality attributes which results in the finalization of product design have been demonstrated in the present work. Every steps were taken after due consideration of risk evolved by virtue of prior technical knowledge and experimentation. In the product design space the product characterization involved critical quality attributes which ultimately leads to critical process parameters that are design space. Control strategies for continuous monitoring process and product have also been recommended. Critical process parameters were also validated to achieve and monitor the quality of final product. The CPP has direct impact on critical quality attributes hence these parameters were develop with proper tolerances. The QbD principle demonstrated in present research will play an important role in the understanding and creating opportunities for investigation and control strategy in formulation
2. Food & Drug Administration Office of Generic Drug Model Quality Overall Summary For IR Product, htt:// www. Fda. Gov/ cder/ogd/ogd model-Qos-IR-product.pdt (Accessed march 31,2006)
3. US Food and Drug Administration. guidance for industry: Q10 quality systems approach to pharmaceutical cGMP regulations (FDA, Rockville, MD, September 2006)
4. Gibson, M., Product Optimization: Pharmaceutical Preformulation and Formulation. Taylor & Francis, New York 2001.
5. Seely, R.J., Haury, J., in: Rathore, A.S., Sofer, G. (Eds.), Process Validation in Manufacturing of Biopharmaceuticals, Taylor & Francis, Boca Raton, FL 2005, pp.13-50
6. US Food and Drug Administration. Pharmaceutical cGMPs for the 21st century: a risk-based approach (FDA, Rockville, MD, August 2002). http://www.fda. gov/oc/guidance/gmp.html
7. US Food and Drug Administration. Guidance for industry:Q9 quality risk management, US Department of Health and Human Service (FDA, Rockville, MD, June2006).
8. Scidenfeid T, RA Fisher. on the Design of Experiment and Statistical Estimation. The Founder of Evolutionary Genetics. 1992; 23-26.
9. US Food and Drug Administration. PAT guidance for industry-a framework for innovative pharmaceutical development, manufacturing and quality assurance(US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine, Office of Regulatory Affairs, Rockville, MD, September, 2004).
10. Watts, C., Clark, J. E., J Pro Ana Tech 2006, 3, 6-9.
11. Swami G, Saraf SA, “Preparation and Evaluation of sustained release micro balloons of propranololˮ, Daru Journal of Pharmaceutical Sciences., 2011; 19(3).
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (SeeÂ The Effect of Open Access).