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TR DİZİN Özgün Makale Scopus
Development and Characterization of a Fixed-Dose Orodispersible Film of Telmisartan and Indapamide for Enhancing Dissolution
Fabad Journal of Pharmaceutical Sciences 2025 Cilt 50 Sayı 3
Scopus Eşleşmesi Bulundu
50
Cilt
513-530
Sayfa
🔓
Açık Erişim
Scopus Yazarları: Dilara Orgul, Aslı Yi̇gi̇t, Yakup Gultekin, Sema Arisoy
Özet
Fixed-dose combination (FDC) of antihypertensive drugs improves efficacy, safety and patient adherence over monotherapy. However, an FDC of telmisartan (TEL) and indapamide (IND), both poorly soluble BCS Class II drugs, has not been available yet. This study aimed to develop an orodispersible film (ODF) containing TEL and IND cyclodextrin (CD) inclusion complexes (ICs) to enhance solubility and improve patient adherence. In the first phase of the study, phase-solubility analysis was performed with β-CD, then the ICs were prepared via kneading and assessed for solubility enhancement and entrapment efficiency. In the second phase, ICs were incorporated into hydroxypropyl-methylcellulose (HPMC) based ODFs using solvent casting. The films were characterized for thickness, mass, and content uniformity, surface pH, water content, folding endurance, Young’s modulus, FTIR, in vitro disintegration, and dissolution. AL-type phase-solubility plots confirmed 1:1 complexation and enhanced solubility by 1.7–4.1 fold, with entrapment efficiency >95%. ICs-loaded ODFs were thin (0.138 mm), uniform in mass (236.39 mg) and content (TEL 97.22%, IND 102.09%), nearly neutral pH, and low in water (2.68%). Mechanical testing showed adequate flexibility and stiffness (100 N/mm² modulus). Disintegration occurred in <35 s. Dissolution exceeded 90% for both drugs within 15 minutes in 6.8 phosphate buffer, whereas in 0.1N HCl, TEL showed complete release in 15 minutes and IND reached 97% after 20 minutes. In conclusion, TEL and IND ICs–loaded HPMC ODFs successfully overcame solubility limitations, offering an immediate-release formulation across the gastrointestinal pH range with favorable physicochemical properties and potential to improve patient adherence.
Anahtar Kelimeler (Scopus)
Cyclodextrin Fixed-Dose Combinations Indapamide Orodispensible Film Solubility Enhancement Telmisartan
Scimago Dergi Bilgisi Otomatik ISSN Eşleştirmesi 2025 yılı verileri
Fabad Journal of Pharmaceutical Sciences
Q3
SJR Quartile
0,211
SJR Skoru
23
H-Index
Kategoriler: Pharmaceutical Science (Q3)
Alanlar: Pharmacology, Toxicology and Pharmaceutics
Ülke: Turkey · Society of Pharmaceutical Sciences of Ankara (FABAD)
Bu bilgiler makale yılına göre Scimago veritabanından ISSN eşleştirmesiyle otomatik getirilmektedir. Dergi sıralama verileri Scimago'nun ilgili yılı baz alınmaktadır.

Anahtar Kelimeler

Cyclodextrin Fixed-Dose Combinations Indapamide Orodispensible Film Solubility Enhancement Telmisartan

Makale Bilgileri

Dergi Fabad Journal of Pharmaceutical Sciences
ISSN 1300-4182
Yıl 2025 / 10. ay
Cilt / Sayı 50 / 3
Makale Türü Özgün Makale
Hakemlik Hakemli
Endeks TR DİZİN
TEŞV Puanı 2025,00
Yayın Dili İngilizce
Kapsam Ulusal
Toplam Yazar 4 kişi
Erişim Türü Basılı+Elektronik
Erişim Linki Makaleye Git
Alan Sağlık Bilimleri Temel Alanı Farmasotik Teknoloji

YÖKSİS Yazar Kaydı

Yazar Adı ÖRGÜL DİLARA,YİĞİT ASLI,GÜLTEKİN YAKUP,ARISOY SEMA
YÖKSİS ID 8977784