A Glance at the Literature review on Buccal films
Yarragunta Roja, Hindustan Abdul Ahad, Haranath Chinthaginjala,
Maninjeri Soumya, Sana Muskan, Nagaraju gari Kavyasree
Department of Industrial Pharmacy, Raghavendra Institute of Pharmaceutical Education and Research (RIPER) - Autonomous, Ananthapuramu, Andhra Pradesh, India.
*Corresponding Author E-mail: andulhindustan@gmail.com
ABSTRACT:
The present article concentrates on the Buccal film. It is a buccoadhesive drug delivery system that enhances the safety, efficacy, and stability of active pharmaceutical ingredients. The buccal film is a novel technology due to its better option to optimize therapeutic efficacy. This drug delivery system is suitable for drugs that pass through high first-pass metabolism and are used for enhancing bioavailability. The buccal film can be formulated as a solvent casting, semi-solid casting, hot-melt extrusion, solid dispersion, or rolling method. Among them, the solvent casting method is mostly adopted. The buccal films are evaluated for mechanical properties viz., Organoleptic assessment, thickness, dryness, tack test, tensile strength, percent elongation, folding endurance, swelling assets, surface pH, contact angle, transparency, uniformity in drug content, disintegration, and in-vitro dissolution tests. The article gave a handful of literature on past work done on buccal films. This article helps with quick references to the earlier attempts so far made on buccal films.
KEYWORDS: Buccal, Bioavailability, Film, Literature, Patient convenience.
INTRODUCTION:
Buccal films are a type of dosage form that uses a water-dispersible polymer to quickly hydrate, adhere, and dissolve when applied to the tongue or oral cavity, resulting in systemic drug delivery1.
The most recent development in buccal administration is buccal films. In addition to being cost-effective and patient-friendly, they have also gained importance as effective and novel drug delivery systems. Since buccal films are intended for attachment to the buccal mucosa, they can be formulated to have local as well as systemic action.
The buccal film may be more flexible and comfortable than buccal tablets. Unlike tablets, buccal films are delivered directly to the systemic circulation through the internal jugular vein, without first-pass metabolism in the liver. Also, the large surface area of the buccal film allows quick wetting, which accelerates the absorption of the drug. The buccal mucosa has a high blood supply, making it an ideal site for drug absorption2.
The ease of administration to pediatric and geriatric patients, as well as to patients who are mentally retarded, disabled, or uncooperative, increases the bioavailability of the dosage form by increasing its residence time at the site of absorption. However, the main limitation of buccal films is that high doses of medication cannot be incorporated. Buccal films can be formulated in such a way that the dissolution rates of drugs can range from minutes to hours.
Orally swallowed dosage forms have the following pitfalls3,4.
· Absorption is slow, so there is a delayed onset of action.
· Not suitable for emergencies or patients who are unconscious.
· Having gastrointestinal disorders such as diarrhea, constipation, ulceration, and hyperacidity in the stomach makes it difficult for a patient to undergo this procedure.
· Often, the medication itself causes these problems, such as aspirin and many NSAIDs, which may cause ulcers in the stomach with repeated use over time.
· Patients suffering from malabsorption syndrome, in which absorption through the small intestine is not possible, should not undergo this procedure.
· insufficient for medications at risk of inactivation or destruction in the GI tract. For example, insulin is a protein. The protein in foods such as meat and fish is digested in the stomach when taken orally.
· It is not recommended for children or infants who are uncooperative.
· Chronic vomiting is not appropriate for patients.
Advantages of buccal dosage forms:
The buccal films have the following positives5,6
· It is possible to achieve a rapid onset of the therapeutic effect not only because of the high blood supply of the area but also because there are no gastrointestinal (GI) factors that can delay absorption (gastric emptying, presence of food, gastric disease, etc.).
· Regarding the oral route, avoiding portal circulation can improve bioavailability by avoiding intestinal and first-pass hepatic metabolism.
· Due to the absence of exposure to the aggressive GI medium, some drugs can be administered buccally (e.g., peptides) that would otherwise be degraded by the gastric pH or enzymes.
The earlier attempts made on buccal films are illustrated in table 1.
Table 1: Previous work on buccal films
Drug |
Polymer |
Reference |
Clotrimazole |
Carbopol-934P and hydroxypropyl cellulose-M |
7Khana et al., 1997 |
Propranolol HCl |
HPC |
8Raghuraman et al., 2002 |
Glipizide |
HPMC and guar gum |
9Chowdary et al., 2004 |
Ketorolac tromethamine |
sodium carboxymethyl cellulose (Na-CMC), hydroxypropyl cellulose (HPC), HPMC and Carbopol 934 |
10Alanazi et al., 2007 |
Giplizide |
HPMC, Na-CMC, carbopol-934P and Eudragit RL-100 |
11Semalty et al., 2008 |
Clotrimazole |
Carbopol |
12Singh et al., 2008 |
Nitrendipine |
HPMC |
13Nappinna et al., 2008 |
Atenolol |
Sodium alginate |
14Satishbabu et al., 2008 |
Losartan potassium |
HPMC and ethyl cellulose |
15Ubathande et al., 2009 |
Flufenamic acid |
Chitosan |
16Mura et at., 2010 |
Nicotine |
HPMC |
17Cilurzo et al., 2010 |
Enalapril maleate |
NA CMC, HPMC, HEC and poly vinylpyrrolidone (PVP) |
18Semalty et al., 2010 |
Tianeptine sodium |
Lycoat NG73 |
19El-setouhy et al., 2010 |
Sertraline HCl |
PVP, and carbopol |
20Mahajan et al., 2012 |
Ropinirole HCl |
Pullulan |
21Panchal et al., 2012 |
Diclofenac sodium |
Sodium alginate and Pectin |
22Pandey et al., 2012 |
Norethindrone |
NA CMC, HPMC, and PVP |
23Nautiya et al., 2013 |
Ivabradine HCl |
HPMC |
24Lodhi et al., 2013 |
Valsartan |
CP 934, HPMC and NA CMC |
25Roy et al., 2013 |
Ivabradine HCl |
Carbopol and HPMC |
26Lodhi et al., 2013 |
Ondansetron HCl |
HPMC |
27Kumria et al., 2013 |
Ranitidine |
HPMC and PVP |
28Chandra et al., 2014 |
Dextromethorphan |
HPMC |
29Sathavahana et al., 2014 |
Simvastatin |
CMC and PVP |
30El-Maghraby et al.., 2015 |
Metformin HCl |
Chitosan |
31Haque et al., 2015 |
Selegiline |
HPMC |
32Al-Dhubiab et al., 2016 |
Metoprolol |
Succinate and PVP K-30 |
33Verma et al., 2016 |
Dimenhydrinate |
HEC and Xanthan gum |
34Yildiz et al., 2016 |
Rizatriptan benzoate |
HPMC, polyvinyl alcohol, and polyethylene oxide |
35Salehi et al., 2017 |
Baclofen |
Carbapol and PVP |
36Ali et al., 2017 |
Aceclofenac |
HPMC Carbopol |
37Saha et al., 2017 |
Baclofen |
HPMC |
38Ali et al., 2017 |
Risperidone |
Carbopol and sodium alginate |
39Celik et al., 2017 |
Tizanidine HCl and Meloxicam |
HPMC |
40Zaman et al., 2018 |
Benzdyamine HCl |
HPMC |
41Alam et al., 2018 |
Triamcinolone acetonide |
Acetylated gellan gum and low esterified citrus pectin |
42Fernandes et al., 2018 |
Captopril |
Acritamer 940, manugel, and hypromellose |
43Begum et al., 2019 |
Glimepiride |
D-tocopherol and polyethylene glycol |
44Basahih et al., 2020 |
CONCLUSION:
The present study concludes that the buccal film is the most accurate and acceptable dosage form, which bypasses the hepatic first-pass effect and shows good bioavailability. This is the most promising and innovative technology, which is useful to all age groups, specifically pediatric, geriatric patients, and to patients with swallowing difficulties. Buccal films can replace the conventional dosage forms, including fast disintegrating tablets due to their advantages over the conventional dosage forms, and they can be manufactured at a low cost. This technology provides a good tool for the maintenance of drug therapeutic value, as well as pharmacoeconomic value.
ACKNOWLEDGMENTS:
The authors thank the college management for their encouragement and support.
REFERENCES:
1. Ahad HA, Chinthaginjala H, Priyanka MS, Raghav DR, Gowthami M, Jyothi VN. Datura stramonium Leaves Mucilage Aided Buccoadhesive Films of Aceclofenac using 32 Factorial Design with Design-Expert Software.
2. Kumria R, Nair AB, Goomber G, Gupta S. Buccal films of prednisolone with enhanced bioavailability. Drug delivery. 2016 Feb 12;23(2):471-8.
3. Ahad HA, Ksheerasagare T, Chelluru A, Haranath C, Reddy GS, Krishna JV. Herbal Mucilage attempted as a Super disintegrating agent in Oral Disintegrating Tablets. Research Journal of Pharmacy and Technology. 2020 Nov 1;13(11):5489-92.
4. Al-Dhubiab BE, Nair AB, Kumria R, Attimarad M, Harsha S. Development, and evaluation of buccal films impregnated with selegiline-loaded nanospheres. Drug delivery. 2016 Sep 1;23(7):2154-62.
5. Hindustan AA, Babu UA, Nagesh K, Kiran DS, Madhavi KB. Fabrication of glimepiride Datura stramonium leaves mucilage and poly vinyl pyrrolidone sustained release matrix tablets: in vitro evaluation. Kathmandu university journal of science, engineering, and technology. 2012;8(1):63-72.
6. Zayed GM, Abd-El Rasoul S, Ibrahim MA, Saddik MS, Alshora DH. In vitro and in vivo characterization of domperidone-loaded fast dissolving buccal films. Saudi pharmaceutical journal. 2020 Mar 1;28(3):266-73.
7. Khana R, Agarwal SP, Ahuja A. Preparation, and evaluation of muco-adhesive buccal films of clotrimazole for oral Candida infections. Indian Journal of pharmaceutical sciences. 1997;59(6):299.
8. Raghuraman S, Velrajan G, Ravi R, Jeyabalan B, Johnson DB, Sankar V. Design, and evaluation of propranolol hydrochloride buccal films. Indian journal of pharmaceutical sciences. 2002;64(1):32
9. Chowdary KR, Rao NK, Malathi K. Ethyl cellulose microspheres of glipizide: Characterization, in vitro and in vivo evaluation. Indian Journal of pharmaceutical sciences. 2004;66(4):412.
10. Alanazi FK, Rahman AA, Mahrous GM, Alsarra IA. Formulation and physicochemical characterisation of buccoadhesive films containing ketorolac. Journal of drug delivery science and technology. 2007 Jan 1;17(3):183-92.
11. M, Semalty A, Kumar G. Formulation, and characterization of mucoadhesive buccal films of glipizide. Indian Journal of Pharmaceutical Sciences. 2008 Jan;70(1):43.
12. Singh S, Jain S, Muthu MS, Tiwari S, Tilak R. Preparation, and evaluation of buccal bioadhesive films containing clotrimazole. Aaps Pharmscitech. 2008 Jun;9(2):660-7.
13. Nappinnai M, Chandanbala R, Balaijirajan R. Formulation, and evaluation of nitrendipine buccal films. Indian journal of pharmaceutical sciences. 2008 Sep;70(5):631.
14. Satishbabu BK, Srinivasan BP. Preparation and evaluation of buccoadhesive films of atenolol. Indian journal of pharmaceutical sciences. 2008 Mar;70(2):175.
15. Ubarhande YB, Regupathy T, Vijaya C, Deshmane SV. Formulation and evaluation of mucoadhesive buccal films of losartan potassium. Research Journal of Pharmacy and Technology. 2009;2(4):833-6.
16. Mura P, Corti G, Cirri M, Maestrelli F, Mennini N, Bragagni M. Development of mucoadhesive films for buccal administration of flufenamic acid: effect of cyclodextrin complexation. Journal of pharmaceutical sciences. 2010 Jul 1;99(7):3019-29
17. Cilurzo F, Cupone IE, Minghetti P, Buratti S, Selmin F, Gennari CG, Montanari L. Nicotine fast dissolving films made of maltodextrins: a feasibility study. Aaps Pharmscitech. 2010 Dec;11(4):1511-7.
18. Singhal P, Jadoun GS, Sinha M, Saraf SA. Formulation and evaluation of buccal patches of terbutaline sulphate. Int J Res Pharm Sci. 2010; 4:440-9.
19. El-Setouhy DA, Abd El-Malak NS. Formulation of a novel tianeptine sodium orodispersible film. Aaps Pharmscitech. 2010 Sep;11(3):1018-25
20. Mahajan A. Formulation and evaluation of fast dissolving buccal films of sertraline. Int J Drug Dev Res. 2012 Jan;4(1):220-6.
21. Panchal MS, Patel H, Bagada A, Vadalia KR. Formulation, and evaluation of mouth dissolving film of ropinirole hydrochloride by using pullulan polymers. International Journal of Pharmaceutical Research & Allied Sciences. 2012;1(3):60-72.
22. Pandey S. Formulation and evaluation of buccal patches of Diclofenac Sodium. International Journal of Scientific & Engineering Research. 2012;3(12):1-7.
23. Nautiyal U. Development and evaluation of buccal film. International Journal of Pharmaceutical and Medicinal Research. 2013 Sep 13; 1:39-43.
24. Lodhi M, Dubey A, Narayan R, Prabhu P, Priya S. Formulation, and evaluation of buccal film of Ivabradine hydrochloride for the treatment of stable angina pectoris. International journal of pharmaceutical investigation. 2013 Jan;3(1):47.
25. Roy AK, Vinod Kumar SM, Bashal SJ, Haque R, Kark R. Formulation, and evaluation of mucoadhesive buccal tablets of valsartan. International Journal of Drug Delivery and Research. 2013; 5:145-55.
26. Lodhi M, Dubey A, Narayan R, Prabhu P, Priya S. Formulation, and evaluation of buccal film of Ivabradine hydrochloride for the treatment of stable angina pectoris. International journal of pharmaceutical investigation. 2013 Jan;3(1):47.
27. Kumria R, Gupta V, Bansal S, Wadhwa J, Nair AB. Oral buccoadhesive films of ondansetron: development and evaluation. International journal of pharmaceutical investigation. 2013 Apr;3(2):112.
28. Chandra D, Chaurasia S, Singh VK, Yadav KK. Chitosan Based Mucoadhesive Microsphere: Versatile Carrier for Nasal Drug Delivery System. WJPR. 2014 Jun 20;3(6):1368-85.
29. Sai Sathavahana C, Allena RT, Getyala A, Gangadharappa H. Formulation and Evaluation of Dextromethorphan Hydrobromide Controlled Release Hollow Microspheres using Natural Polymer. Indones. J. Pharm. 2014; 25:181-8.
30. El-Maghraby GM, Abdelzaher MM. Formulation and evaluation of simvastatin buccal film. Journal of Aplied Pharmaceutical Science. 2015 Apr;5(04):70-7.
31. Haque SE, Sheela A. Development of polymer-bound fast-dissolving metformin buccal film with disintegrants. International journal of nanomedicine. 2015;10(Suppl 1):199.
32. Al-Dhubiab BE, Nair AB, Kumria R, Attimarad M, Harsha S. Development, and evaluation of buccal films impregnated with selegiline-loaded nanospheres. Drug delivery. 2016 Sep 1;23(7):2154-62.
33. Verma N, Verma A, Dubey J. Formulation and Evaluation of chitosan containing mucoadhesive buccal patches of metoprolol succinate. Journal of drug delivery and therapeutics. 2016 Mar 14;6(2):14-20.
34. Yildiz Pekoz A, Sedef Erdal M, Okyar A, Ocak M, Tekeli F, Kaptan E, Sagirli O, Araman A. Preparation, and in-vivo evaluation of dimenhydrinate buccal mucoadhesive films with enhanced bioavailability. Drug development and industrial pharmacy. 2016 Jun 2;42(6):916-25.
35. Salehi S, Boddohi S. New formulation, and approach for mucoadhesive buccal film of rizatriptan benzoate. Progress in biomaterials. 2017 Dec;6(4):175-87.
36. Ali MA, Sabati AM, Ali BA. Formulation and Evaluation of Baclofen Mucoadhesive Buccal Films. FABAD Journal of Pharmaceutical Sciences. 2017 Jul 1;42(3):179-90.
37. Saha P, Das PS. Formulation Development and Evaluation of Buccal Patches of Aceclofenac for Gingivitis. Research Journal of Pharmaceutical Dosage Forms and Technology. 2017;9(4):163-7.
38. Ali MA, Sabati AM, Ali BA. Formulation and Evaluation of Baclofen Mucoadhesive Buccal Films. FABAD Journal of Pharmaceutical Sciences. 2017 Jul 1;42(3):179-90.
39. Çelik B. Risperidone mucoadhesive buccal tablets: formulation design, optimization, and evaluation. Drug design, development, and therapy. 2017; 11:3355.
40. Zaman M, Hanif M, Shaheryar ZA. Development of Tizanidine HCl-Meloxicam loaded mucoadhesive buccal films: In-vitro and in-vivo evaluation. PloS one. 2018 Mar 22;13(3): e0194410
41. Alam MM, Minj E, Yadav RK, Mehan S. Neuroprotective potential of adenyl cyclase/cAMP/CREB and mitochondrial CoQ10 activator in amyotrophic lateral sclerosis rats. Curr. Bioact. Compd. 2020; 16:1-8.
42. Fernandes FP, Fortes AC, da Cruz Fonseca SG, Breitkreutz J, Ferraz HG. Manufacture and characterization of mucoadhesive buccal films based on pectin and gellan gum containing triamcinolone acetonide. International Journal of Polymer Science. 2018 Jan 1;2018.
43. Begum SK, Sura RS, Phanindra B, Kumar PP. Formulation and Evaluation of Mucoadhesive Buccal Tablets of Captopril. Research Journal of Pharmaceutical Dosage Forms and Technology. 2019;11(3):164-8.
44. Basahih TS, Alamoudi AA, El-Say KM, Alhakamy NA, Ahmed OA. Improved transmucosal delivery of glimepiride via unidirectional release buccal film loaded with Vitamin E TPGS-based nanocarrier. Dose-Response. 2020 Jul 31;18(3):1559325820945164.
Received on 24.11.2021 Modified on 29.12.2021
Accepted on 26.01.2022 ©AandV Publications All Right Reserved
Res. J. Pharma. Dosage Forms and Tech.2022; 14(2):189-192.
DOI: 10.52711/0975-4377.2022.00030