Dhananjay Mistry,
Sangram Keshari Panda,
Kamalesh Mistry,
Dillip Kumar Brahma,
Manas Ranjan Nayak,
Sumi Barman,
- Research Scholar, Department of Pharmacognosy, Jeypore College of Pharmacy, Bana Vihar, Randapali, Jeypore, Odisha, India
- Professor, Department of Pharmacognosy, Jeypore College of Pharmacy, Bana Vihar, Randapali, Jeypore, Odisha, India
- Assistant Professor, NSHM Institute of Pharmaceutical Technology, Shibtala Rd, Muchipara, Arrah Kalinagar, Ar-ra, Durgapur, West Bengal, India
- Professor & HOD, NSHM Institute of Pharmaceutical Technology, Shibtala Rd, Muchipara, Arrah Kalinagar, Ar-ra, Durgapur, West Bengal, India
- Associate Professor, NSHM Institute of Pharmaceutical Technology, Shibtala Rd, Muchipara, Arrah Kalinagar, Ar-ra, Durgapur, West Bengal, India
- Assistant Professor, NSHM Institute of Pharmaceutical Technology, Shibtala Rd, Muchipara, Arrah Kalinagar, Ar-ra, Durgapur, West Bengal, India
Abstract
Background: Pharmaceutical scientists have developed Orally Disintegrating Tablets (ODTs) to advance patient drug acceptance and biological system availability through simplified medi-cation delivery especially for children and senior citizens and people who cannot swallow pills regularly. The oral disintegrating tablets dissolve in the mouth within thirty seconds or less (USP 701) while needing no additional liquid thus making them suitable for both emergency treatments. Objective: The research examines ODT development strategies by examining critical formula-tion elements and choosing the right excipients then measures approaches to boost drug availa-bility and details manufacturing processes alongside regulatory framework demands. Regulatory Considerations: The production of ODTs requires adherence to FDA along with EMA and ICH guidelines that enforce rapid drug dissolution (≥85% within 15 minutes accord-ing to USP 711) and permitted friability (≤1%) and ICH Q1A specified long-term stability (25°C/60% RH, 40°C/75% RH accelerated testing). The choice of direct compression along with lyophilization spray drying and three-dimensional printing systems serves as fundamental factors to develop robust fast-disintegrating tablets with controlled drug release. Future Directions: The development of ODTs extends into therapy areas with biologic-based substances and vaccines alongside gene therapies therefore enabling needle-free delivery of macromolecules peptides and monoclonal antibodies (mAbs).
Keywords: Orally Disintegrating Tablets, Drug Bioavailability, Solubility Enhancement, Superdisinte-grants, Regulatory Compliance, Advanced Manufacturing
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Research & Reviews: A Journal of Drug Design & Discovery
| Volume | 13 | |
| 02 | ||
| Received | 07/07/2026 | |
| Accepted | 19/07/2026 | |
| Published | 21/07/2026 | |
| Publication Time | 14 Days |