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Formulation, Optimization, and In-Vitro Evaluation of Hyaluronic Acid Buccal Films Containing Benzydamine Hydrochloride

Yıl 2021, Cilt: 11 Sayı: 3, 325 - 330, 20.09.2021
https://doi.org/10.33631/duzcesbed.833024

Öz

Aim: Mucoadhesive buccal films provide drug delivery for both local and systemic circulation with increased patient compliance. The objective of this study was to develop a buccal film containing benzydamine hydrochloride (BNZ) by using hyaluronic acid (HA) as a film-forming agent and glycerin (Gly) as a plasticizer for the anti-inflammatory effect on the mucosal ulcer.
Material and Methods: The effects of different concentrations of HA and Gly on responses were analyzed using 23 factorial design. The HA and Gly ratio were selected as independent factors, and work of mucoadhesion, tensile strength, elongation at break, and contact angle values were chosen as dependent factors. Nine different film formulations were prepared at constant BNZ concentration (0.15%) by solvent casting method. Mechanical and mucoadhesion properties of film formulations were evaluated, and also contact angles were calculated. The BNZ release profiles were evaluated in simulated saliva solution (pH 6.8).
Results: All film formulations were successfully prepared by solvent casting method. Increasing HA concentration from 0.5 to 2 % raised the mechanical and mucoadhesion properties of film formulations. Although the addition of Gly decreased the tensile strength values, it increased the elongation at break values about ten times. All formulations released more than 60 % BNZ in 60 mins.
Conclusion: It is concluded that HA oral mucoadhesive film formulations containing BNZ are promising for treating oral ulcers.

Kaynakça

  • Alves TFR, Rios AC, Pontes K da S, Portella DL, Aranha N, Severino P, et al. Bilayer mucoadhesive buccal film for mucosal ulcers treatment: development, characterization, and single study case. Pharmaceutics. 2020; 12(7): 1-24.
  • Yaprak Karavana S, Güneri P, Ertan G. Benzydamine hydrochloride buccal bioadhesive gels designed for oral ulcers: preparation, rheological, textural, mucoadhesive and release properties. Pharm Dev Technol. 2009; 14(6): 623-31.
  • Pechova V, Gajdziok J, Muselik J, Vetchy D. Development of orodispersible films containing benzydamine hydrochloride using a modified solvent casting method. AAPS Pharm Sci Tech. 2018; 19(6): 2509-18.
  • Borges AF, Silva C, Coelho JFJ, Simoes S. Oral films: Current status and future perspectives: I-galenical development and quality attributes. J Control Release. 2015; 206: 1-19.
  • Semalty M, Semalty A, Kumar G. Formulation and characterization of mucoadhesive buccal films of glipizide. Indian J Pharm Sci. 2008; 70(1): 43-8.
  • Nappinnai M, Chandanbala R, Balaijirajan R. Formulation and evaluation of nitrendipine buccal films. Indian J Pharm Sci. 2008; 70(5): 631-5.
  • Preis M, Knop K, Breitkreutz J. Mechanical strength test for orodispersible and buccal films. Int J Pharm. 2014; 461(1-2): 22-9.
  • Mahajan A, Chhabra N, Aggarwal G. Formulation and characterization of fast dissolving buccal films: a review. Der Pharm Lett. 2011; 3(1): 152-65.
  • Akbal O, Cevher E, Araman AO. The development and in vitro evaluation of benzydamine hydrochloride medicated chewing gum formulations. Istanbul J Pharm. 2017; 47(2): 45-51.
  • Khabazian A, Tavakoli A, Soltani S, Karami E, Mohaghegh N. Comparison of benzydamine hydrochloride mouthwash 0.15% and ıbuprofen in reducing postoperative pain during 24 hours after crown lengthening: a randomized clinical trial. Open Dent J. 2020; 14(1): 66-70.
  • Carvalho JPF, Silva ACQ, Bastos V, Oliveira H, Pinto RJB, Silvestre AJD, et al. Nanocellulose-based patches loaded with hyaluronic acid and diclofenac towards aphthous stomatitis treatment. Nanomaterials. 2020; 10(4): 628.
  • Kim S, Cho DH, Kweon DK, Jang EH, Hong JY, Lim ST. Improvement of mechanical properties of orodispersible hyaluronic acid film by carboxymethyl cellulose addition. Food Sci Biotechnol. 2020; 29(9): 1233-9.
  • Necas J, Bartosikova L, Brauner P, Kolar J. Hyaluronic acid (hyaluronan): a review. Vet Med. 2008; 53(8): 397-411.
  • Abo-shady AZ, Elkammar H, Elwazzan VS, Nasr M. Formulation and clinical evaluation of mucoadhesive buccal films containing hyaluronic acid for treatment of aphthous ulcer. J Drug Deliv Sci Technol. 2020; 55: 101442.
  • Rachid O, Rawas-Qalaji M, Simons FER, Simons KJ. Dissolution testing of sublingual tablets: a novel ın vitro method. AAPS PharmSciTech. 2011; 12(2): 544-52.
  • Casale M, Moffa A, Vella P, Rinaldi V, Lopez MA, Grimaldi V, et al. Systematic review: the efficacy of topical hyaluronic acid on oral ulcers. J Biol Regul Homeost Agents. 2017; 31(4-S2): 63-9.
  • Graça MFP, Miguel SP, Cabral CSD, Correia IJ. Hyaluronic acid-based wound dressings: a review. Carbohydr Polym. 2020; 241: 116364.
  • Essendoubi M, Gobinet C, Reynaud R, Angiboust JF, Manfait M, Piot O. Human skin penetration of hyaluronic acid of different molecular weights as probed by Raman spectroscopy. Skin Res Technol. 2016; 22(1); 55-62.
  • Okonogi S, Khongkhunthian S, Jaturasitha S. Development of mucoadhesive buccal films from rice for pharmaceutical delivery systems. Drug Discov Ther. 2014; 8(6): 262-7.
  • Rajput G, Majmudar F, Patel J. Formulation and evaluation of mucoadhesive glipizide films. Acta Pharm. 2011; 61(2): 203-16.
  • Salehi S, Boddohi S. New formulation and approach for mucoadhesive buccal film of rizatriptan benzoate. Prog Biomater. 2017; 6(4): 175-87.
  • Pornpitchanarong C, Rojanarata T, Opanasopit P, Ngawhirunpat, T, Patrojanasophon P. Clotrimazole nanosuspensions-loaded hyaluronic acid-catechol/polyvinyl alcohol mucoadhesive films for oral candidiasis treatment. J Drug Deliv Sci Technol. 2020; 60: 101927.
  • Sonvico F, Barbieri S, Colombo P, Mucchino C, Barocelli E, Cantoni AM, et al. Physicochemical and pharmacokinetic properties of polymeric films loaded with cisplatin for the treatment of malignant pleural mesothelioma. J Thorac Dis. 2018; 10(S2): S194-206.

Benzidamin Hidroklorür İçeren Hyaluronik Asit Bukkal Filmlerinin Formülasyon, Optimizasyon ve İn-Vitro Değerlendirilmesi

Yıl 2021, Cilt: 11 Sayı: 3, 325 - 330, 20.09.2021
https://doi.org/10.33631/duzcesbed.833024

Öz

Amaç: Mukoadezif bukkal filmler, artmış hasta uyumu ile hem lokal hem de sistemik dolaşıma ilaç geçişini sağlayan sistemlerdir. Bu çalışmanın amacı, mukozal ülser üzerindeki antiinflamatuvar etki için film oluşturucu ajan olarak hyaluronik asit (HA) ve plastizer olarak gliserin (Gly) kullanarak benzidamin hidroklorür (BNZ) içeren bukkal film geliştirmektir.
Gereç ve Yöntemler: Farklı HA ve Gly konsantrasyonlarının etkisi 23 faktöryel tasarım kullanılarak analiz edilmiştir. HA ve Gly oranı bağımsız faktörler seçildi ve mukoadezyon, gerilme kuvveti, kopmada uzama ve temas açısı değerleri bağımlı faktörler olarak seçildi. Dokuz farklı film formülasyonu çözücü dökme yöntemi ile sabit BNZ konsantrasyonunda (% 0,15) hazırlandı. Film formülasyonlarının mekanik, mukoadezyon özellikleri değerlendirildi ve temas açıları hesaplandı. BNZ salım profilleri, yapay tükrük çözeltisinde (pH 6.8) gerçekleştirildi.
Bulgular: Film formülasyonlarının hepsi çözücü dökme yöntemi ile başarıyla hazırlanmıştır. HA konsantrasyonunun % 0,5'ten %2'ye yükseltilmesi, film formülasyonlarının mekanik ve mukoadezif özelliklerini artırmıştır. Gly ilavesi kopma gerilim değerlerini düşürmesine rağmen kopma uzaması değerlerini yaklaşık 10 kat arttırmıştır. Tüm formülasyonlar 60 dakikada % 60'tan fazla BNZ salmıştır.
Sonuç: BNZ içeren HA oral mukoadezif filmlerin oral ülserlerin tedavisi için umut verici bir formülasyon olduğu sonucuna varılmıştır.

Kaynakça

  • Alves TFR, Rios AC, Pontes K da S, Portella DL, Aranha N, Severino P, et al. Bilayer mucoadhesive buccal film for mucosal ulcers treatment: development, characterization, and single study case. Pharmaceutics. 2020; 12(7): 1-24.
  • Yaprak Karavana S, Güneri P, Ertan G. Benzydamine hydrochloride buccal bioadhesive gels designed for oral ulcers: preparation, rheological, textural, mucoadhesive and release properties. Pharm Dev Technol. 2009; 14(6): 623-31.
  • Pechova V, Gajdziok J, Muselik J, Vetchy D. Development of orodispersible films containing benzydamine hydrochloride using a modified solvent casting method. AAPS Pharm Sci Tech. 2018; 19(6): 2509-18.
  • Borges AF, Silva C, Coelho JFJ, Simoes S. Oral films: Current status and future perspectives: I-galenical development and quality attributes. J Control Release. 2015; 206: 1-19.
  • Semalty M, Semalty A, Kumar G. Formulation and characterization of mucoadhesive buccal films of glipizide. Indian J Pharm Sci. 2008; 70(1): 43-8.
  • Nappinnai M, Chandanbala R, Balaijirajan R. Formulation and evaluation of nitrendipine buccal films. Indian J Pharm Sci. 2008; 70(5): 631-5.
  • Preis M, Knop K, Breitkreutz J. Mechanical strength test for orodispersible and buccal films. Int J Pharm. 2014; 461(1-2): 22-9.
  • Mahajan A, Chhabra N, Aggarwal G. Formulation and characterization of fast dissolving buccal films: a review. Der Pharm Lett. 2011; 3(1): 152-65.
  • Akbal O, Cevher E, Araman AO. The development and in vitro evaluation of benzydamine hydrochloride medicated chewing gum formulations. Istanbul J Pharm. 2017; 47(2): 45-51.
  • Khabazian A, Tavakoli A, Soltani S, Karami E, Mohaghegh N. Comparison of benzydamine hydrochloride mouthwash 0.15% and ıbuprofen in reducing postoperative pain during 24 hours after crown lengthening: a randomized clinical trial. Open Dent J. 2020; 14(1): 66-70.
  • Carvalho JPF, Silva ACQ, Bastos V, Oliveira H, Pinto RJB, Silvestre AJD, et al. Nanocellulose-based patches loaded with hyaluronic acid and diclofenac towards aphthous stomatitis treatment. Nanomaterials. 2020; 10(4): 628.
  • Kim S, Cho DH, Kweon DK, Jang EH, Hong JY, Lim ST. Improvement of mechanical properties of orodispersible hyaluronic acid film by carboxymethyl cellulose addition. Food Sci Biotechnol. 2020; 29(9): 1233-9.
  • Necas J, Bartosikova L, Brauner P, Kolar J. Hyaluronic acid (hyaluronan): a review. Vet Med. 2008; 53(8): 397-411.
  • Abo-shady AZ, Elkammar H, Elwazzan VS, Nasr M. Formulation and clinical evaluation of mucoadhesive buccal films containing hyaluronic acid for treatment of aphthous ulcer. J Drug Deliv Sci Technol. 2020; 55: 101442.
  • Rachid O, Rawas-Qalaji M, Simons FER, Simons KJ. Dissolution testing of sublingual tablets: a novel ın vitro method. AAPS PharmSciTech. 2011; 12(2): 544-52.
  • Casale M, Moffa A, Vella P, Rinaldi V, Lopez MA, Grimaldi V, et al. Systematic review: the efficacy of topical hyaluronic acid on oral ulcers. J Biol Regul Homeost Agents. 2017; 31(4-S2): 63-9.
  • Graça MFP, Miguel SP, Cabral CSD, Correia IJ. Hyaluronic acid-based wound dressings: a review. Carbohydr Polym. 2020; 241: 116364.
  • Essendoubi M, Gobinet C, Reynaud R, Angiboust JF, Manfait M, Piot O. Human skin penetration of hyaluronic acid of different molecular weights as probed by Raman spectroscopy. Skin Res Technol. 2016; 22(1); 55-62.
  • Okonogi S, Khongkhunthian S, Jaturasitha S. Development of mucoadhesive buccal films from rice for pharmaceutical delivery systems. Drug Discov Ther. 2014; 8(6): 262-7.
  • Rajput G, Majmudar F, Patel J. Formulation and evaluation of mucoadhesive glipizide films. Acta Pharm. 2011; 61(2): 203-16.
  • Salehi S, Boddohi S. New formulation and approach for mucoadhesive buccal film of rizatriptan benzoate. Prog Biomater. 2017; 6(4): 175-87.
  • Pornpitchanarong C, Rojanarata T, Opanasopit P, Ngawhirunpat, T, Patrojanasophon P. Clotrimazole nanosuspensions-loaded hyaluronic acid-catechol/polyvinyl alcohol mucoadhesive films for oral candidiasis treatment. J Drug Deliv Sci Technol. 2020; 60: 101927.
  • Sonvico F, Barbieri S, Colombo P, Mucchino C, Barocelli E, Cantoni AM, et al. Physicochemical and pharmacokinetic properties of polymeric films loaded with cisplatin for the treatment of malignant pleural mesothelioma. J Thorac Dis. 2018; 10(S2): S194-206.
Toplam 23 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Sağlık Kurumları Yönetimi
Bölüm Araştırma Makaleleri
Yazarlar

Alptuğ Karaküçük 0000-0002-9061-2427

Serdar Tort 0000-0003-4945-5420

Yayımlanma Tarihi 20 Eylül 2021
Gönderilme Tarihi 28 Kasım 2020
Yayımlandığı Sayı Yıl 2021 Cilt: 11 Sayı: 3

Kaynak Göster

APA Karaküçük, A., & Tort, S. (2021). Formulation, Optimization, and In-Vitro Evaluation of Hyaluronic Acid Buccal Films Containing Benzydamine Hydrochloride. Düzce Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi, 11(3), 325-330. https://doi.org/10.33631/duzcesbed.833024
AMA Karaküçük A, Tort S. Formulation, Optimization, and In-Vitro Evaluation of Hyaluronic Acid Buccal Films Containing Benzydamine Hydrochloride. DÜ Sağlık Bil Enst Derg. Eylül 2021;11(3):325-330. doi:10.33631/duzcesbed.833024
Chicago Karaküçük, Alptuğ, ve Serdar Tort. “Formulation, Optimization, and In-Vitro Evaluation of Hyaluronic Acid Buccal Films Containing Benzydamine Hydrochloride”. Düzce Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi 11, sy. 3 (Eylül 2021): 325-30. https://doi.org/10.33631/duzcesbed.833024.
EndNote Karaküçük A, Tort S (01 Eylül 2021) Formulation, Optimization, and In-Vitro Evaluation of Hyaluronic Acid Buccal Films Containing Benzydamine Hydrochloride. Düzce Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi 11 3 325–330.
IEEE A. Karaküçük ve S. Tort, “Formulation, Optimization, and In-Vitro Evaluation of Hyaluronic Acid Buccal Films Containing Benzydamine Hydrochloride”, DÜ Sağlık Bil Enst Derg, c. 11, sy. 3, ss. 325–330, 2021, doi: 10.33631/duzcesbed.833024.
ISNAD Karaküçük, Alptuğ - Tort, Serdar. “Formulation, Optimization, and In-Vitro Evaluation of Hyaluronic Acid Buccal Films Containing Benzydamine Hydrochloride”. Düzce Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi 11/3 (Eylül 2021), 325-330. https://doi.org/10.33631/duzcesbed.833024.
JAMA Karaküçük A, Tort S. Formulation, Optimization, and In-Vitro Evaluation of Hyaluronic Acid Buccal Films Containing Benzydamine Hydrochloride. DÜ Sağlık Bil Enst Derg. 2021;11:325–330.
MLA Karaküçük, Alptuğ ve Serdar Tort. “Formulation, Optimization, and In-Vitro Evaluation of Hyaluronic Acid Buccal Films Containing Benzydamine Hydrochloride”. Düzce Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi, c. 11, sy. 3, 2021, ss. 325-30, doi:10.33631/duzcesbed.833024.
Vancouver Karaküçük A, Tort S. Formulation, Optimization, and In-Vitro Evaluation of Hyaluronic Acid Buccal Films Containing Benzydamine Hydrochloride. DÜ Sağlık Bil Enst Derg. 2021;11(3):325-30.