Formulation, Optimization and In-Vivo Pharmacokinetic Evaluation of Carvedilol Mucoadhesive Buccal Films by Using Natural Polymers


  • Leela Lakshmi Vajrala Department of Pharmaceutics, Jagan’s College of Pharmacy, Jangalakandriga, Nellore - 524346, Andhra Pradesh, India
  • M S Umashankar Departmet of Pharmaceutics, SRM College of Pharmacy, SRM Institute of Science and Technology (formerly known as SRM University), Kattankulathur, Chennai -6032023, Tamil Nadu, India
  • M Alagusundaram Department of Pharmaceutics, Jagan’s College of Pharmacy, Jangalakandriga, Nellore - 524346, Andhra Pradesh, India


Buccal film, critical material attributes, Critical quality attributes, Quality by design, Factorial design, Optimization


This study utilizes Quality by Design (QbD) principles to optimize carvedilol buccal film composition. The optimization method used a factorial design, changing three important material attributes (CMAs): the concentration of lime basil seed mucilage, the concentration of plasticizer (PG 10%), and the percentage of permeation enhancer at three different levels (low, medium, and high). Critical quality attributes (CQAs) included drug content (%), drug release percentage, and folding endurance. A 33 factorial experimental design created a first-order response surface model. The optimized buccal formulation, R20, featured high polymer, plasticizer, and medium permeation enhancer concentrations. It yielded favorable CQAs: 96.9 ± 2.4% drug content, 97.4 ± 2.4% drug release at 24 hours, and 422 ± 12 folding endurance. The identified optimal concentrations, established through the solvent casting process, offer a promising buccal film formulation for further research and potential in vivo studies.

Author Biography

M Alagusundaram , Department of Pharmaceutics, Jagan’s College of Pharmacy, Jangalakandriga, Nellore - 524346, Andhra Pradesh, India

Department of Pharmaceutics, School of Pharmacy, ITM University, Gwalior – 474001, Madhya Pradesh, India


Vanessa H, Vidya S, Katrusha H, Danica Vidović Juras, Martin Greenberg. New developments and opportunities in oral mucosal drug delivery for local and systemic disease. Adv Drug Deliv Rev.2012;64(01):16-28.

Hoogstraate JAH, Wertz PW. Drug delivery via the buccal the buccal mucosa. J Pharm Sci Tech Today. 1998;1(01):309-316.

Mathias NR and Hussain AM. Non-invasive systemic drug delivery: develop ability considerations for alternate routes of administration. J Pharm Sci 2010; 99(01):1-20.

Shojaei Amir H. Buccal Mucosa as a route for systemic drug delivery. J Pharm Sci. 1998; 1(01):15-30.

Flávia Chiva Carvalho, Marcos Luciano Bruschi, Raul Cesar Evangelista, Maria Palmira Daflon Gremião. Mucoadhesive drug delivery systems. Braz J Pharm Sci. 2010; 46: 1-18.

Chinna Reddy PKS, Chaitanya, Madhusudan Rao Y. A review on bioadhesive buccal drug delivery systems: current status of formulation and evaluation methods. Daru. 2011; 19(06):385–403.

Satishbabu BK, Srinivasan BP. Preparation and evaluation of buccoadhesive films of carvedilol. Indian J Pharm Sci. 2008;70(02):175-179.

Amanpreet Kaur, Gurpreet Kaur. Mucoadhesive buccal patches based on interpolymer complexes of chitosan pectin for delivery of Carvedilol. Saudi Pharm J. 2012; 20(01):21-27.

Yamsani VV, Gannu R, Kolli C, Rao MEB, Yamsani MR. Development and in vitro evaluation of buccoadhesive carvedilol tablets. J Acta Pharm. 2007;57(2):185‐197.

Abd-Elbary A, AMA Makky, MI Tadros and AA Alaa-eldin. Development and in vitro evaluation of mucoadhesive bilayer buccal tablets of carvedilol. Int J Pharm Sci. 2015; 7(01):172-176.

Khazaei N, Esmaiili M, Djomeh ZE, Ghasemlou M, Jouki M. Characterization of new biodegradable edible film made from basil seed (Ocimum basilicum L.) gum. Carbohydrate polymers. 2014;15(102):199-206.

Trastullo R, Abruzzo A, Saladini B. Design and evaluation of buccal films as paediatric dosage form for transmucosal of ondansetron. Eur J Pharm Biopharm. 2016; 105:115–121.

Dipak Malpure rajaram, Sharada Deore Laxman. Buccal mucoadhesive films: A review; Syst Rev Pharm. 2017; 8(01): 31-38.

Gamal M El-Maghraby, Mona M Abdelzaher. Formulation and evaluation of simvastatin buccal film. J Appl Pharm Sci. 2015;5(04):70-77.

Satishbabu BK, Srinivasan BP. Preparation and evaluation of buccoadhesive films of atenolol. Indian J Pharm Sci. 2008;70(02):175-179.

Abouhussein, El-bary, Shalaby and El-Nabarawi. Chitosan mucoadhesive buccal films: effect of different casting solvents on their physicochemical properties. Int J Pharm Sci. 2016; 8(09):206-213.

Singh B, Chakkal S K, Ahuja N. Formulation and Optimization of Controlled Release Mucoadhesive Tablets of Atenolol Using Response Surface Methodology. JAAPS Pharm Sci Tech. 2006; 7(01):19-22

Vishal V, Bilaskar, Indrajeet S Patil, Omkar A patil, Girishchandra R Mandke, Shrinivas K Mohite. Design, development and optimization of pulsatile drug delivery of antihypertensive drug. International research journal of pharmaceutical and biosciences. 2018; 4(06):12-19.

Shrivastava AR, Ursekar B, Kapadia CJ. Design, optimization. preparation and evaluation of dispersion granules of valsartan and formulation into tablets. Curr Drug Deliv. 2009;6(01):28‑37.

Peh KK, Wong CF. Polymeric films as vehicle for buccal delivery: swelling, mechanical, and bioadhesive properties. J Pharm Sci. 1999; 2(02):53-61.

Perumal V A, Lutchman D, Mackraj I, Govender T. Formulation of monolayered films with drug and polymers of opposing solubilities, Inter Jou of Pharmaceutics 2008;358 (01):184–191.

Joydip Kundu, Chinmoy Patra, Kundu S C. Design, fabrication and characterization of silk fibroin-HPMC-PEG blended films as vehicle for transmucosal delivery, Materials Science and Engineering.2008;28(08):1376–1380.

Alanazi F K, Abdel Rahman A, Mahrous G M, Alsarra I A. Formulation and physicochemical characterization of buccoadhesive films containing ketorolac, J Drug Del Sci Tech. 2007; 17(01) :1-10.

Noha Adel Nafee, Nabila Ahmed Boraie, Fatma Ahmed Ismail, Lobna Mohamed Mortada. Design and characterization of mucoadhesive buccal patches containing Cetylpyridinium chloride, Acta Pharm. 2003; 53(03):199–212.

Myung Kwan Chun, Byoung Tae Kwak, Hoo Kyun Choi. Preparation of Buccal Patch Composed of Carbopol, Poloxamer and Hydroxy propyl methyl cellulose, Arch Pharm Res. 2003; 26(11):973-978.

Rajesh Singh Patel, Poddar S. Development and characterization of mucoadhesive buccal Patches of Salbutamol sulphate, Current Drug Delivery. 2009;6(01):140-144.

Roy S, Pal K, Anis A, Pramanik K, Prabhakar B. Polymers in Mucoadhesive Drug Delivery System: A Brief Note, Designed monomers and polymers. 2009; 12:483-495.

Rinku Khurana, Alka Ahuja, Roop K Khar. Development and evaluation of mucoadhesive films of miconazole nitrate, Indian J Pharm Sci.2000; 62(06):447-453.

Kharenko E A, Larionova N I, Demina N B. Mucoadhesive drug delivery systems: quantitative assessment of interaction between synthetic and natural polymer films and mucosa, Pharmaceutical Chemistry Journal.2008; 42(07):392-399.

Kashappa Goud HD, Pramod Kumar TM. Preparation and Evaluation of a Novel Buccal Adhesive System, AAPS PharmSciTech. 2004; 5(03) :1-9.

Balamurugan K, Pandit J K, Choudary P K, Balasubramaniyam J. Systemic absorption of Propranolol Hydrochloride from buccoadhesive films, Indian J Pharm Sci. 2001; 63(06) :473-480.

Ellen Hagesaether, Marianne Hiorth, Sverre Arne Sande. Mucoadhesion and drug permeability of free mixed films of pectin and chitosan: An in vitro and ex vivo study, European Journal of Pharmaceutics and Biopharmaceutics.2009; 71(2):325–331.

Supriya S. Shidhaye, Nilesh S. Saindane, Sagar Sutar, Vilasrao Kadam. Mucoadhesive Bilayered Patches for Administration of Sumatriptan Succinate, AAPS PharmSciTech. 2008; 9(3):909-916.

Shaila Lewis, G.Subramanian,S Pandey, N Udupa. Design, evaluation and pharmacokinetic study of mucoadhesive buccal tablets of nicotine for smoking cessation, Indian J Pharm Sci.2006; 68(06):829-831.

Koland M, Charyulu RN, Vijayanarayana K, Prabhu P. In vitro and in vivo evaluation of chitosan buccal films of ondansetron hydrochloride. Int J Pharm Investig. 2011; 1(3):164-71.

Zaman M, Hanif M, Shaheryar ZA. Development of Tizanidine HCl-Meloxicam loaded mucoadhesive buccal films: In vitro and in vivo evaluation. PLoS One. 2018; 22; 13(3):e0194410.



How to Cite

Vajrala, L. L., Umashankar , M. S., & Alagusundaram , M. (2023). Formulation, Optimization and In-Vivo Pharmacokinetic Evaluation of Carvedilol Mucoadhesive Buccal Films by Using Natural Polymers: Tropical Journal of Natural Product Research (TJNPR), 7(10), 4927–4936. Retrieved from