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1. Dr. Babasaheb Ambedkar Technological University ,Lonere ,Raigad
DR. VEDPRAKASH PATIL PHARMACY COLLEGE Gevrai Tanda, Paithan Road, Chh.Sambhajinagar
Formulation And Characterization Of Mucoadhesive Buccal Films of Repaglinide
Presented by:- Pooja Bhagwat Ghandge
( B. Pharm 7th Semester )
PRN No. 2221541823005
Guided by :- Dr. Vaibhav Changediya (Associate Professor)

2. INTRODUCTION
• A hyperglycaemic syndrome known as diabetes can emerge postprandial or during a fast. Peristent hyperglycemia, a hallmark of diabetes
mellitus (DM), has been associated to end organ, dysregulation, and refusal in organs and tissues including the kidney, brain, heart, and
blood vessls, million individuals worldwide had diabetes mellitus. According to the International Diabetes Federation (IDF), and by 2030,
that figure is expected to rise to 552 million (Whitting et al., 2011). The current diagnosis standards for diabetes were released by the World
helth organization (WHO) in a consensus statement in 2006.
• Repaglinide (REP), Belongs to class of meglinide, is a an oral short acting antidiabetic drug used for type II diabetes patient. Repaglinide
act by selective blockage of ATP – dependent K channel cellular membrane in pancreatic B – cells with subsequent stimulation of insulin
secretion. It is extensive metabolized by hepatic cytochromes into inactive metabolites with poor bioavailaibility . It is a BCS class II durgs,
where dissolution is the absorption rate determining step with significant effect on drug bioavailaibility.

3. ADVANTAGE
1] Improved Patient compliance.
2] Reduced dosing frequency.
3] Controlled and Sustained release.
4] Bypass of first – pass metabolism.
DISADVANTAGE
1] Difficulty in handling and packaging.
2] Limited Surface area for absorption.
3] Sensitivity to environmental condition.

4. LITERATURE REVIEW
• P.Sandhya, Sameera Khan 2014- Repaglinide is an antidiabetic drug used extensively in the treatment of diabetes type II. The present
study was carried out to formulate and evaluate biphasic floating mini tablets of Repaglinide. The mini tablets were encapsulated in a
capsule. Immediate release mini tablet (IRMT) were manufactured by direct compression using various superdisintegrating agents, each mini
tablet containing 2mg Repaglinide.
• A.M. Gulandi-Signorini, G.Giorgi – 2001 Although the improvement on insulin therapy since it was first conceived, it was physiological
secretion of pancreatic b – cells and research to find new insulin formulation and new routes of continues. Human biosysthetic insulin ( rapid
acting intermediates acting and long acting ), produced by recombinant DNA technique is currently availaible.
• Basak et al.- 2008 In conventional wet granulation technique 500mg. Metformin hydrochloride each containing matrix tablet were
prepared.Polymer combination were selected on the basis of trial formulation of tablet compression.
• Lesley J Scott – 2012 Repaglinide, a carbamoybenzoic acid derivative, is chemically related to the meglinide class of insulin
secretaKgogues, but unrelated to the sulfonylurea insulin secretogogues.Meglinide, including repaglinide, have a distict binding site at the B
– cells membrane, which differs from that of sulfonylureas, and corresponds to the sulfonylureas insulin secretogogues.

5. AIM AND OBJECTIVE
AIM :- To Formulate and characterize of Mucoadhesive buccal films of Repaglinide.
OBJECTIVE :-
1) The objective of this work is the Formulation and Characterization of Mucoadhesive Buccal Films of Repaglinide using plasticizer such as
propylene glycol, polymers such as Hydroxypropyl methylcellulose (HPMC).
2) The main objective of the Formulation and Characterization of Mucoadhesive Buccal films of Repaglinide is to enhance drug delivery.
3) The Formulate Mucoadhesive Buccal Films of Repaglinide having minimum side effects.

6. PLAN OF WORK
Literature
Materials and Method
Preparation of Mucoadhesive buccal films
Evaluation of films
Result
Conclusion

7. MATERIALS AND METHOD
Chemicals :-
• Hydroxypropyl methyl cellulose (HPMC)
• Sodium carboxy methyl cellulose
• Polyvinyl pyrrolidone (PVP)
• Polyvinyl alcohol
• Propylene glycol
• Preparation of Repaglinide films :
• Oral mucosal mucoadhesive films were created using the solvent casting technique. Methanol was used to dissipate repaglinide (20mg in
2ml). Each type of HPMC, SCMC, PVA AND PVP K30 was individually dissolved in distilled water. Later, the necessary amount of these
polymeric solutions was combined. Due to the incorporation of the repaglinide solution, the previously mentioned solution was stirred
mechanically for 15 minutes. Plasticizer propylene glycol was added. After already being sonicated for 30 minutes to eradicate air
bubbles, this solution was than kept in a desiccator. The solution was poured into a glass cast that was 10mm long by 4mm wide, and it
was then dried in a hot air oven at 60 °C for 6 – 7 hours. The dried films were carefully removed, examined for any cracks, and cut into
square pieces with sides of 2 by 2sq cm that each contained 2mg medication. (Table)

8. Ingredients F1 F2 F3 F4 F5 F6 F7 F8 F9
Repaglinide (mg) 2 2 2 2 2 2 2 2 2
HPMC K 15 (mg) 12 - 12 - - - - - -
HPMC E 15 (mg) - - - - - - 10 12 14
SCMC (mg) 6 6 6 - - - - - -
PVP K 30 (mg) 2 2 2 2 2 2 2 2 2
PVA (mg) - - - 5 6 7 5 6 7
Gaur Gum (mg) 2 12 - 10 12 14 - - -
Propylene glycol (ml) 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2
Distilled water q.s q.s q.s q.s q.s q.s q.s q.s q.s
Table 1: Composition of Repaglinide films with variable polymer ratios

9. EVALUATION OF FILMS
• This evaluation test for mucoadhesive buccal film of Repaglinide ensures that the buccal films of Repaglinide are safe, effective and suitable
for patient use.
1] Film Weight and thickness
2] Measurement of Surface pH
3] Swelling Studies
4] Folding endurance of films
5] Drug content
6] Stability Studies

10. RESULT
•Film weight and thickness:
•Repaglinide mucoadhesive buccal films are prepared by solvent casting technique. The prepared films were evaluated for
various parameters such as weight variation was found to be in the range of (50.7±0.45mg to 55.7±0.98mg), thickness of films
was determined within the range of (0.276mm±0.005 - 0.372mm±0.01), folding endurance was within the range (300±1.5 to
352±1.15), surface pH was found to be within the range of salivary pH (6.5-6.7), swelling studies obtained values were in the
range of (143.80%±0.79 to 171.30%±1.30).

11. Formulation Code Weight variation (mg)
±S.D
Thickness (mm)
±S.D
Folding
Endurance
±S.D
Surface pH ±S.D Drug
Content (%)
± S. D
F1 52.3±0.68 0.353±0.015 327±0.52 6.5±0.24 97.01±0.17
F2 56.2±0.46 0.343±0.01 350±0.12 6.6±0.05 82.08±0.28
F3 54.2±0.38 0.366±0.015 342±0.23 6.7±0.15 93.28±0.42
F4 55.2±0.94 0.311±0.01 329±0.55 6.6±0.34 85.82±0.95
F5 52.9±0.51 0.336±0.015 352±1.15 6.6±0.15 89.55±0.78
F6 50.7±0.45 0.372±0.01 300±1.5 6.5±0.1 97.01±0.51
F7 51.9±0.40 0.321±0.005 345±1.21 6.7±0.06 78.35±0.11
F8 55.7±0.98 0.284±0.01 315±1.18 6.5±0.17 82.08±0.32
F9 54.3±0.43 0.276±0.005 335±1.15 6.7±0.05 97.32±0.18
Table 1: Evaluation of physical parameters for formulated films

12. CONCLUSION
• Repaglinide belongs to the meglitinide pharmacological class of diabetes medicines. It has a half-life of one hour and a 56 percent oral
bioavailability. Initial research was done to change the concentration of polymers and manufactured films in order to optimise the buccal film
composition (F1-F9). Nine formulations were created, each of which had different amounts of hydroxypropyl methylcellulose (HPMC K, E
15 M), sodium carboxymethyl cellulose (SCMC), guar gum, and polyvinyl alcohol (PVA). Propylene glycol was employed as a plasticizer
and polyvinyl pyrrolidone (PVP K 30) as an adhesive. Films were created and tested with drugs hidden therein. F9 formulation optimization
was carried out.
• Weight variation, film thickness, folding endurance, swelling test, surface pH, drug content.

13. REFERENCE
• Kulkarni G. S, Divya S. kumar, Vikram T. Chodhary. Formulation and characterization of Mucoadhesive buccal films of Repaglinide.
Research Journal of Pharmacy and Technology 2025 0974-360.
• Semalty M, Semalty A, Kumar G. Formulation and characterization of mucoadhesive buccal films of glipizide. Indian Journal of
Pharmaceutical Science. 2008.43-8
• Prasanth VV, Mamatha Y, Arunkumar S, Mathew ST. Formulation and evaluation of mucoadhesive buccal patches of aceclofenac. Scholar
Research Library ( Der Pharmacia Letter). 2012, 297-306.
• TSB NB, Bhagawati ST, Manjunath K, Siddesh HM. Formulation and evaluation of fast dissoving films of Repaglinide solid dispersion.
World Journal of Advanced Research and Review.2020,262-74
• Hiyoshi T, Takano Y, Nagano Y, Fujimoto S, Takahashi Y, Imai T. Postprandial hyperglycemia and postprandial hypertriglyceridemia in type
II Diabetes. Journal of Biomedical Research 2017.

14. THANK YOU