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)
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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
/ 9. ay
Cilt / Sayı
50
/ 3
Sayfalar
513 – 530
Makale Türü
Özgün Makale
Hakemlik
Hakemli
Endeks
TR DİZİN
TEŞV Puanı
2025,00
Yayın Dili
İngilizce
Kapsam
Ulusal
Toplam Yazar
4 kişi
Erişim Türü
Elektronik
Erişim Linki
Makaleye Git
Alan
Sağlık Bilimleri Temel Alanı
Farmasotik Teknoloji
YÖKSİS Yazar Kaydı
Yazar Adı
ÖRGÜL DİLARA,YİGİT ASLI,GÜLTEKİN YAKUP,ARISOY SEMA
YÖKSİS ID
9004000
Hızlı Erişim
Metrikler
TEŞV Puanı
2025,00
Yazar Sayısı
4