Journal of Advanced Research in Health Sciences

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Research Article


DOI :10.26650/JARHS2025-1517952   IUP :10.26650/JARHS2025-1517952    Full Text (PDF)

DEVELOPMENT AND EVALUATION OF BIOADHESIVE MUCOSAL DOSAGE FORMS OF PILOCARPINE HCL FOR XEROSTOMIA THERAPY

Özlem Akbal Dağıstan, Nur Sena Başarır, Sinem Yaprak Karavana, Ayça Yıldız Peköz

Objective: Saliva maintains vital mouth functions and acts as a barrier to dental health. Xerostomia, which is characterised as a feeling of dry mouth, adversely affects the patient’s quality of life. Palliative therapies, such as sialagogues, form the based on treatment of xerostomia. The FDAapproved sialagogue pilocarpine is currently recommended as the firstline medication for patients. Owing to its wide range of action, oral pilocarpine users may experience several negative side effects. The purpose of this study was to increase the duration of action and prevent systemic side effects of pilocarpine hydrochloride by designing and evaluating prolonged-release formulations of the drug using either xanthan gum, hydroxyethyl cellulose, or a combination of these two natural polymers buccal bioadhesive films.

Material and Methods: The films were analysed for their physicochemical, mechanical, bioadhesive, swelling, in vitro release, and in vitro cytotoxicity.

Results: Physicochemical and mechanical feature examinations revealed that the Xanthan-HEC combinations showed better results compared to the single polymer-used formulations. The in vitro dissolving profiles of all the optimal formulations showed a sustained release pattern with a steady-state plateau after an initial fast release. Using various release kinetic models to assess drug release kinetics revealed that the Higuchi and Korsmeyer-Peppas correlations are primarily followed by drug release from buccal films.

Conclusion: The findings show that the mucoadhesive buccal formulation is a viable method for pilocarpine localised distribution that is both safe and effective in treating xerostomia. Further in vivo studies are planned to assess the pharmacokinetic and histopathological effects of the formulation.

Keywords: Buccal delivery, buccal film, pilocarpine hydrochloride, sialogogues, xerostomia
DOI :10.26650/JARHS2025-1517952   IUP :10.26650/JARHS2025-1517952    Full Text (PDF)

KSEROSTOMİ TEDAVİSİ İÇİN PİLOKARPİN HCL’NİN BİYOADEZİF MUKOZAL DOZAJ FORMLARININ GELİŞTİRİLMESİ VE DEĞERLENDİRİLMESİ

Özlem Akbal Dağıstan, Nur Sena Başarır, Sinem Yaprak Karavana, Ayça Yıldız Peköz

Amaç: Tükürük salgısı hem ağız içi fonksiyonları hem de diş sağlığını koru maktadır. Bu nedenle ağız kuruluğu hissi ile karakterize olan kserostomi durumu hastanın yaşam kalitesini olumsuz yönde etkilemektedir. Sialagoglar gibi palyatif tedaviler, kserostominin tedavisinin temelini oluş turmaktadır. Mevcut hastalar için birinci basamak ilaç tedavisi olarak, Amerikan ilaç ve Gıda Dairesi tarafından onaylı pilokarpin HCl önerilmek tedir. Oral yoldan pilokarpin kullanımı, geniş etki yelpazesi nedeniyle çeşitli olumsuz yan etkinin ortaya çıkmasına neden olabilmektedir. Çalışmanın amacı, pilokarpin hidroklorürün etki süresini arttırmak ve siste mik yan etkilerini önlemek için; ksantan sakızı, hidroksietil selüloz veya bu iki doğal polimerin kombinasyonunun kullanıldığı bukkal biyoadhezif film lerinin hazırlanması ve ilacın uzun süreli salınımını sağlayan formülasyon larının tasarlanıp değerlendirilmesidir. 

Gereç ve Yöntemler: Bukkal filmler; fizikokimyasal, mekanik, biyoadheziflik, şişme, in vitro salım ve in vitro sitotoksisite açısından analiz edimiştir.

Bulgular: Fizikokimyasal ve mekanik özellikler Ksantan-HEC kombinasyonlarının tek polimerin kullanıldığı formülasyonlara göre daha iyi sonuçlar verdiğini göstermiştir. Tüm optimal formülasyonların in vitro çözünürlük profilleri, başlangıçtaki hızlı salımdan sonra kararlı durum platosuyla birlikte sürekli salım modeli göstermiştir. İlaç salım kinetiğini değerlendirmek için kullanılan çeşitli salım kinetik modelleri öncelikli Higuchi ve KorsmeyerPeppas korelasyonlarının gerçekleştiğini bukkal filmlerden ilaç salımının takip ettiğini göstermiştir.

Sonuç: Bulgular mukoadezif bukkal formülasyonun lokalize dağılımı için pilokarpinin kserostomi tedavisinde hem güvenli hem de etkili olarak uygulanabilir bir yöntem olduğunu göstermektedir. İleri çalışmalar olarak formülasyonun farmakokinetik ve histopatolojik etkilerini değerlendirmek için in vivo deneyler planlanmaktadır.

Keywords: Bukkal uygulama, bukkal film, pilokarpin hidroklorür, sialagog, kserostomi

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APA

Akbal Dağıstan, Ö., Başarır, N.S., Karavana, S.Y., & Yıldız Peköz, A. (2025). DEVELOPMENT AND EVALUATION OF BIOADHESIVE MUCOSAL DOSAGE FORMS OF PILOCARPINE HCL FOR XEROSTOMIA THERAPY. Journal of Advanced Research in Health Sciences, 8(1), 34-41. https://doi.org/10.26650/JARHS2025-1517952


AMA

Akbal Dağıstan Ö, Başarır N S, Karavana S Y, Yıldız Peköz A. DEVELOPMENT AND EVALUATION OF BIOADHESIVE MUCOSAL DOSAGE FORMS OF PILOCARPINE HCL FOR XEROSTOMIA THERAPY. Journal of Advanced Research in Health Sciences. 2025;8(1):34-41. https://doi.org/10.26650/JARHS2025-1517952


ABNT

Akbal Dağıstan, Ö.; Başarır, N.S.; Karavana, S.Y.; Yıldız Peköz, A. DEVELOPMENT AND EVALUATION OF BIOADHESIVE MUCOSAL DOSAGE FORMS OF PILOCARPINE HCL FOR XEROSTOMIA THERAPY. Journal of Advanced Research in Health Sciences, [Publisher Location], v. 8, n. 1, p. 34-41, 2025.


Chicago: Author-Date Style

Akbal Dağıstan, Özlem, and Nur Sena Başarır and Sinem Yaprak Karavana and Ayça Yıldız Peköz. 2025. “DEVELOPMENT AND EVALUATION OF BIOADHESIVE MUCOSAL DOSAGE FORMS OF PILOCARPINE HCL FOR XEROSTOMIA THERAPY.” Journal of Advanced Research in Health Sciences 8, no. 1: 34-41. https://doi.org/10.26650/JARHS2025-1517952


Chicago: Humanities Style

Akbal Dağıstan, Özlem, and Nur Sena Başarır and Sinem Yaprak Karavana and Ayça Yıldız Peköz. “DEVELOPMENT AND EVALUATION OF BIOADHESIVE MUCOSAL DOSAGE FORMS OF PILOCARPINE HCL FOR XEROSTOMIA THERAPY.” Journal of Advanced Research in Health Sciences 8, no. 1 (Mar. 2025): 34-41. https://doi.org/10.26650/JARHS2025-1517952


Harvard: Australian Style

Akbal Dağıstan, Ö & Başarır, NS & Karavana, SY & Yıldız Peköz, A 2025, 'DEVELOPMENT AND EVALUATION OF BIOADHESIVE MUCOSAL DOSAGE FORMS OF PILOCARPINE HCL FOR XEROSTOMIA THERAPY', Journal of Advanced Research in Health Sciences, vol. 8, no. 1, pp. 34-41, viewed 12 Mar. 2025, https://doi.org/10.26650/JARHS2025-1517952


Harvard: Author-Date Style

Akbal Dağıstan, Ö. and Başarır, N.S. and Karavana, S.Y. and Yıldız Peköz, A. (2025) ‘DEVELOPMENT AND EVALUATION OF BIOADHESIVE MUCOSAL DOSAGE FORMS OF PILOCARPINE HCL FOR XEROSTOMIA THERAPY’, Journal of Advanced Research in Health Sciences, 8(1), pp. 34-41. https://doi.org/10.26650/JARHS2025-1517952 (12 Mar. 2025).


MLA

Akbal Dağıstan, Özlem, and Nur Sena Başarır and Sinem Yaprak Karavana and Ayça Yıldız Peköz. “DEVELOPMENT AND EVALUATION OF BIOADHESIVE MUCOSAL DOSAGE FORMS OF PILOCARPINE HCL FOR XEROSTOMIA THERAPY.” Journal of Advanced Research in Health Sciences, vol. 8, no. 1, 2025, pp. 34-41. [Database Container], https://doi.org/10.26650/JARHS2025-1517952


Vancouver

Akbal Dağıstan Ö, Başarır NS, Karavana SY, Yıldız Peköz A. DEVELOPMENT AND EVALUATION OF BIOADHESIVE MUCOSAL DOSAGE FORMS OF PILOCARPINE HCL FOR XEROSTOMIA THERAPY. Journal of Advanced Research in Health Sciences [Internet]. 12 Mar. 2025 [cited 12 Mar. 2025];8(1):34-41. Available from: https://doi.org/10.26650/JARHS2025-1517952 doi: 10.26650/JARHS2025-1517952


ISNAD

Akbal Dağıstan, Özlem - Başarır, NurSena - Karavana, SinemYaprak - Yıldız Peköz, Ayça. “DEVELOPMENT AND EVALUATION OF BIOADHESIVE MUCOSAL DOSAGE FORMS OF PILOCARPINE HCL FOR XEROSTOMIA THERAPY”. Journal of Advanced Research in Health Sciences 8/1 (Mar. 2025): 34-41. https://doi.org/10.26650/JARHS2025-1517952



TIMELINE


Submitted17.07.2024
Accepted28.10.2024
Published Online24.01.2025

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