1Assistant Professor, Government Pharmacy College Nalanda, B.M.I.M.S. Campus, Pawapuri, Nalanda. Email: piyushchandra001@gmail.com; ORCID: 0009-0005-2651-9913
2Professor and HOD, Department of Pharmaceutics, Faculty of Pharmacy, Sree Balaji Medical College and Hospital Campus, Bharath Institute of Higher Education and Research, Chromepet, Chennai-44. ORCID: 0009-0000-4506-7573
3Professor, Gurukul Institute of Pharmaceutical Sciences, Badesh Kalan, Khamanon, Fatehgarh Sahib, Punjab. Email: jas_nirman@rediffmail.com
4Assistant Professor, Department of Pathological Physiology and Pathological Anatomy, Fergana Medical Institute of Public Health, Yangi turon street 2A, Fergana. Email: dr.rustamjon@mail.ru; ORCID: 0009-0001-7529-6040
5Assistant Professor, Department of Pathological Physiology and Pathological Anatomy, Fergana Medical Institute of Public Health, Yangi turon street 2A. Email: yusupovagulnara@mail.ru
6Assistant Professor, Department of Folk Medicine and Pharmacology, Fergana Medical Institute of Public Health, Yangi Turon 2A, Fergana - 150100. Email: Polatovaxmadjon6@gmail.com
7Assistant Professor, Department of Pharmaceutics, School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Patel Nagar, Dehradun, Uttarakhand. Email: 9805081516pg78@gmail.com
*Corresponding author: Poonam Gangwar, Assistant Professor, Department of Pharmaceutics, School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Patel Nagar, Dehradun, Uttarakhand. Email: 9805081516pg78@gmail.com
T2DM is a progressive metabolic disorder requiring long-term pharmacotherapy. Despite the availability of effective oral anti-diabetic agents, medication non-adherence remains a formidable barrier to successful glycemic control, driven by factors including forgetfulness, polypharmacy, and dysphagia. Orodispersible films offer a patient-centric alternative that addresses these barriers through rapid disintegration without water or swallowing. Sitagliptin-metformin ODFs were prepared by the solvent casting method using Hydroxypropyl Methylcellulose (HPMC E5) as the film-forming polymer, polyethylene glycol (PEG 400) as plasticizer, and crospovidone as superdisintegrant. Nine formulations (F1-F9) were developed and evaluated for physicochemical properties including thickness, weight variation, surface pH, folding endurance, tensile strength, and percentage elongation. All formulations exhibited uniform thickness (82-96 µm), weight variation (46.5-54.8 mg), and neutral surface pH (6.2-6.7), indicating mucosal compatibility. Mechanical testing revealed tensile strength ranging from 8.5-14.2 MPa and percentage elongation from 12.3-23.8%, with plasticizer concentration inversely affecting tensile strength while enhancing flexibility. Formulations containing crospovidone demonstrated significantly faster disintegration (p<0.05). The optimized formulation (F6) showed superior properties: disintegration time of 18±3 seconds, folding endurance of 275±18, and tensile strength of 11.8 MPa with 23.8% elongation. Drug release studies demonstrated rapid dissolution, with >95% of both sitagliptin and metformin released within 6 minutes. Drug content uniformity was within pharmacopoeial limits (98.7±1.8% for sitagliptin; 97.5±2.1% for metformin). FTIR and DSC studies confirmed no significant drug-excipient interactions, and accelerated stability studies revealed no substantial changes over six months. The developed sitagliptin-metformin orodispersible film, particularly formulation F6, represents a stable, patient-centric dosage form with excellent mechanical properties, ultra-fast disintegration, and rapid drug release. By addressing key adherence barriers including forgetfulness, dysphagia, and polypharmacy, this innovative formulation offers significant potential to improve therapeutic outcomes in T2DM management. The findings provide a strong foundation for further clinical development and underscore the value of advanced drug delivery technologies in chronic disease management.
Keywords: Orodispersible films, sitagliptin, metformin, Type 2 Diabetes Mellitus, patient adherence, solvent casting, fixed-dose combination, rapid disintegration
How to cite this article: Chandra P, Begum MS, Singh J, Rustamjon K, Karimovna YG, Komiljonovich PA, Gangwar P. Formulation and In Vitro Evaluation of Sitagliptin-Metformin Orodispersible Films for Enhanced Patient Adherence. Int J Drug Deliv Technol. 2026;16(11s): 574-583. DOI: 10.25258/ijddt.16.11s.57
Source of support: Nil.
Conflict of interest: None