International Journal of Drug Delivery Technology
Volume 14, Issue 4

Development and Evaluation of Antifungal Drug Product by Solid Dispersion Technique using Drug Coating and Seal Coating Approach (Itraconazole Capsules 100 mg)

Shinde NK, Mane DV*

PG and Research Center, Shri Chhtrapati Shivaji Mahavidhlay, Umarga, Dharashiv, Maharashtra, India 

Received: 9th Aug, 2024; Revised: 4th Oct, 2024; Accepted: 27th Nov, 2024; Available Online: 25th Dec, 2024

ABSTRACT

A very important stage in developing and preserving the quality of any pharmaceutical drug product is validation. Drug product validation creates the written proof that offers a high level of certainty that a manufacturing process will reliably provide a product with predefined standards and quality features. Studying the process performance certification of the drug product Itraconazole Capsules 100 mg Immediate Release Capsule dosage form was the primary goal of my research. The research conducted here guarantees that the production process is appropriate for the intended use and that the final product continuously satisfies predefined requirements and quality standards. Sifting, dry mixing, wet granulation, drying, sizing, blending, lubrication, capsule filling, packing, and analysis of in-process tests and final product are only a few of the processes in the production process that are covered in depth. This study used developmental research to identify Critical Process Parameters (CPPs) that were involved in sifting, dry mixing, wet granulation, drying, sizing, blending, and capsule filling. The CPPs were then assessed during the process validation study. All of the critical quality attributes (also known as critical control parameters) were monitored during this process, including blend uniformity (BU), water content, blend physical characteristics, capsule physical parameters, description, water content (final product), dissolution, dosage unit uniformity, assay, degradation products, and microbiological examination. Following discussion and analysis of the analytical data, it may be said that this manufacturing process can reliably produce a product that satisfies its predefined specifications and quality features. As a result, the medicinal product's manufacturing method has been verified and is suitable for regular production of 100 mg Itraconazole Capsules.

Keywords: Process Validation, Itraconazole, Capsules, Critical Process Parameters, Critical Quality Attributes, Finished product

How to cite this article: Shinde NK, Mane DV. Development and Evaluation of Antifungal Drug Product by Solid Dispersion Technique using Drug Coating and Seal Coating Approach (Itraconazole Capsules 100 mg)International Journal of Drug Delivery Technology. 2024;14(4):2146-53 doi: 10.25258/ijddt.14.4.28

REFERENCES

  1. S. Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Centre for Biologics Evaluation and Research (CBER), Centre for Veterinary Medicine (CVM). Guidance for industry: process validation: general principles and practices. January 2011.
  2. Office of Federal Register, National Archives and Records Administration. Current good manufacturing practice for finished pharmaceuticals. Code of Federal Regulations, Part 211. Washington, DC, USA; 1989.
  3. S. Food and Drug Administration. What's new [Internet]. Availablefrom: http://www.fda.gov/cder/whatsnew.html
  4. World Health WHO guidelines [Internet]. Available from: http://www.who guidelines.com
  5. Pranshu T, Vishal S, Shrivastava B, Arora V. Validation: a critical parameter for quality control of pharmaceuticals. J Drug Deliv Ther. 2012;2(3):34–40.
  6. Patel V. Process validation: an essential process in pharmaceutical industry [Internet]. Pharmainfo.net; January    Availablefrom: http://www.pharmainfo.net
  7. John M. Validation overview & ICH validation documents, tools of method validation and parameters of method validation.
  8. Dashora K, Singh D, Kumar N, Sharma S, Gupta A. Validation - the essential quality assurance tool for pharma industries. 2007.
  9. Sravani Shilpa K, Meka Anand Kumar, SenthilKumarFormulation and process validation of clopidogrel bisulfate 300 mg tablet. Int J Pharm Qual Assur. 2011;3(4):1–14.
  10. Seth AK, Gupta R, Verma S, Yadav A, Sharma N. Process validation of paracetamol Int J Pharm Sci [Internet]. 2011.
  11. Tangri P, Pranshu T, Singh N, Sharma Validation: a critical parameter for quality control of pharmaceuticals. J Drug Deliv Ther. 2012;2(3):34–40.
  12. Sindhur Nag N, Gouthami B, Madhuri L, Lavanyareddy V, Krishnaveni N, Meyyanathan SN, Suresh K. The concept of process validation in tablet J Pharm Res. 2012;4(2):1264–7.
  13. Sharma T, Solanki NS. Process validation: an essentiality in pharmaceutical Int J Pharm Res Dev.
  14. Nash RA, Wachter AH. Pharmaceutical process validation. New York: Marcel Dekker, Inc.; 2003.
  15. Potdar MA. Pharmaceutical quality assurance. Pune: Nirali Prakashan; 2007.