Global Research Connect Publication

We provide unique ISBN, professional Cover Design, wide Coverage and Indexing.


  Book

Innovations in Oral, Injectable, and Transdermal Drug Delivery Systems

Subject Area: Pharmacy, Medical, Dental Science
Pages: 234
Published On: 10-Nov-2025
Online Since: 10-Nov-2025

 Read More >>

 Book Chapter

REGULATORY AND QUALITY ASPECTS IN NOVEL DELIVERY SYSTEMS

Author(s): Dr. VR Ravikkumar, Dr. Jeevanandham Somasundaram, Dr. Sarfaraz Ahmad, Krutika Arun More, Jyotiprakash Bhanja

Email(s): ravisrkumar@yahoo.com , spjeeva1983@gmail.com , spjeeva1983@gmail.com , ahirekrutika9@gmail.com , jyotiprbhanja@gmail.com

Address: Dr. VR Ravikkumar Professor and HOD, Dept. of Pharmacognosy, The Erode College of Pharmacy, Perundurai Main Road, Veppampalayam, Erode - 638112, Tamil Nadu, India.
Dr. Jeevanandham Somasundaram Director, Professor of Pharmaceutics Sri Shanmugha College of Pharmacy, (Affiliated with The Tamil Nadu Dr.M.G.R. Medical University, Chennai), Pullipalayam, Morur(Po), Sankari (Tk), Salem district, Tamil Nadu - 637 304, India.
Dr. Sarfaraz Ahmad (B.Pharm, M.Pharm, PhD) Assistant Professor Pharmacy Practice Research Unit (PPRU), Department of Clinical Practice, College of Pharmacy, Jazan University, Jazan,
Krutika Arun More Assistant Professor Mahatma Gandhi Vidyamandir's Pharmacy College Panchvati Nashik Maharashtra Pin 422003
Jyotiprakash Bhanja PhD Scholar Institute: Faculty of Pharmacy, CV Raman Global University Address: Bidyanagar, Mahura, Janla, Bhubaneswar, Odisha, India, Pin: 752054

Published In:   Book, Innovations in Oral, Injectable, and Transdermal Drug Delivery Systems

Year of Publication:  November, 2025

Online since:  November 10, 2025

DOI: Not Available

 View HTML        View PDF

ABSTRACT:
Novel Drug Delivery Systems (NDDS) such as nanoparticles, liposomes, micelles, dendrimers, and transdermal patches have revolutionized therapeutic approaches by enabling targeted delivery, controlled release, and enhanced bioavailability. However, their complexity demands robust regulatory and quality frameworks to ensure consistent performance and patient safety. 🔍 Regulatory Considerations • Global Guidelines: NDDS must comply with standards from agencies like the FDA, EMA, and CDSCO, which emphasize preclinical safety, clinical efficacy, and manufacturing controls. • Classification Challenges: Many NDDS blur the lines between drugs, biologics, and devices, requiring case-by-case regulatory pathways. • Documentation Requirements: Developers must submit detailed CMC (Chemistry, Manufacturing, and Controls) data, stability studies, and risk assessments. ✅ Quality Assurance Strategies • Quality by Design (QbD): A proactive approach that integrates critical quality attributes (CQAs) and process analytical technology (PAT) to ensure product consistency. • Good Manufacturing Practices (GMP): Essential for maintaining batch-to-batch reproducibility, especially in scale-up of nanocarriers and complex formulations. • Analytical Validation: Advanced techniques like dynamic light scattering, zeta potential analysis, and HPLC are used to characterize NDDS. ⚠️ Challenges and Future Directions • Regulatory harmonization across countries remains a hurdle. • Real-time release testing and adaptive manufacturing may redefine quality paradigms. • Integration of personalized medicine and theranostics into NDDS will require new regulatory models. These aspects collectively ensure that NDDS not only meet therapeutic goals but also adhere to stringent safety and quality standards, paving the way for their successful translation from bench to bedside.


Keywords:

Cite this article:
working


1.     Adepu, S., & Ramakrishna, S. (2021). Controlled drug delivery systems: current status and future directions. Molecules, 26(19), 5905.

2.     Al-Jawadi, S., Capasso, P., & Sharma, M. (2018). The road to market implantable drug delivery systems: a review on US FDA’s regulatory framework and quality control requirements. Pharmaceutical Development and Technology, 23(10), 953-963.

3.     CsĂłka, I., Ismail, R., JĂłjĂĄrt-Laczkovich, O., & Pallagi, E. (2021). Regulatory considerations, challenges and risk-based approach in nanomedicine development. Current Medicinal Chemistry, 28(36), 7461-7476.

4.     GĂśnen, T., Ten, C. W., & Mehrizi-Sani, A. (2024). Electric power distribution engineering. CRC press.

5.     Liu, D., Yang, F., Xiong, F., & Gu, N. (2016). The smart drug delivery system and its clinical potential. Theranostics, 6(9), 1306.

6.     Liu, P., Chen, G., & Zhang, J. (2022). A review of liposomes as a drug delivery system: current status of approved products, regulatory environments, and future perspectives. Molecules, 27(4), 1372.

7.     Mishra, V., Bansal, K. K., Verma, A., Yadav, N., Thakur, S., Sudhakar, K., & Rosenholm, J. M. (2018). Solid lipid nanoparticles: Emerging colloidal nano drug delivery systems. Pharmaceutics, 10(4), 191.

8.     Musazzi, U. M., Franzè, S., Condorelli, F., Minghetti, P., & Caliceti, P. (2023). Feeding Next‐Generation Nanomedicines to Europe: Regulatory and Quality Challenges. Advanced healthcare materials, 12(30), 2301956.

9.     Panzitta, M., Bruno, G., Giovagnoli, S., Mendicino, F. R., & Ricci, M. (2015). Drug delivery system innovation and health technology assessment: upgrading from clinical to technological assessment. International Journal of Pharmaceutics, 495(2), 1005-1018.

10.  Sainz, V., Conniot, J., Matos, A. I., Peres, C., Zupanǒiǒ, E., Moura, L., ... & Gaspar, R. S. (2015). Regulatory aspects on nanomedicines. Biochemical and biophysical research communications, 468(3), 504-510.

11.  Selmin, F., Musazzi, U. M., Magri, G., Rocco, P., Cilurzo, F., & Minghetti, P. (2020). Regulatory aspects and quality controls of polymer-based parenteral long-acting drug products: the challenge of approving copies. Drug Discovery Today, 25(2), 321-329.

12.  Shi, L., & Singh, D. A. (2021). Delivering Health Care in America: A Systems Approach:. Jones & Bartlett Learning.

13.  Soares, S., Sousa, J., Pais, A., & Vitorino, C. (2018). Nanomedicine: principles, properties, and regulatory issues. Frontiers in chemistry, 6, 360.

14.  Sousa, A. S., Serra, J., Estevens, C., Costa, R., & Ribeiro, A. J. (2023). A quality by design approach in oral extended release drug delivery systems: where we are and where we are going?. Journal of Pharmaceutical Investigation, 53(2), 269-306.

15.  Wen, H., Jung, H., & Li, X. (2015). Drug delivery approaches in addressing clinical pharmacology-related issues: opportunities and challenges. The AAPS journal, 17(6), 1327-1340.




Author/Editor Information

Dr Sumit Bhatt

Assistant Professor and PhD Scholar in Oral and Maxillofacial Surgery at Rajasthan Dental College and Hospital, Nirwan University, Jaipur

Dr. Mrunal Dave

Associate dentist “Bethlehem Smile Design” Bethlehem, Pennsylvania USA.

Dr. Suyash Pratap Singh

Dr. Suyash Pratap Singh is an Endodontist and a Senior Lecturer at the Department of Conservative Dentistry and Endodontics, Institute of Dental Sciences, Bareilly

Dr. S. Shruti

Dr. S. Shruti is an Associate Professor and Acting Head in the Department of Rasashastra evam Bhaishajyakalpana at Sri Ganganagar College of Ayurvedic Science and Hospital, Sri Ganganagar, Rajasthan, India