Hipertensi merupakan penyakit kronis dengan prevalensi tinggi yang sering disebut silent killer karena dapat menyebabkan komplikasi fatal apabila tidak terkontrol. Salah satu terapi yang digunakan adalah Propranolol HCl, tetapi bentuk sediaan tablet sering menyulitkan pasien geriatri dan penderita disfagia. Untuk meningkatkan kepatuhan dan kenyamanan pasien, dikembangkan sediaan orodispersible film (ODF) Propranolol HCl yang dapat larut cepat di rongga mulut tanpa air.
Penelitian ini bertujuan untuk mengoptimasi kombinasi polimer HPMC dan CMC-Na sebagai basis film serta mengevaluasi kandungan kadar dan profil disolusi ODF formula optimum. Metode solvent casting digunakan dalam pembuatan film, sedangkan optimasi formula dilakukan dengan Simplex Lattice Design (SLD) menggunakan perangkat lunak Design Expert. Evaluasi meliputi organoleptik, bobot. ketebalan, pH, ketahanan pelipatan, waktu disintegrasi, kandungan kadar, serta profil disolusi.
Hasil penelitian menunjukkan bahwa formula optimum ODF Propranolol HCl diperoleh pada kombinasi HPMC 1,290?n CMC-Na 0,202% yang memiliki bobot 0,090±0,003 g; ketebalan 0,037±0,011 mm; ketahanan pelipatan >500 kali; pH 6,69±0,084; dan waktu disintegrasi 12,96±0,797 detik. Uji kadar menunjukkan kandungan zat aktif sebesar 19,719 mg/film dengan profil disolusi mencapai 94,80% terlarut dalam waktu 15 menit. Kombinasi HPMC dan CMC-Na menghasilkan ODF Propranolol HCl yang memenuhi standar mutu fisik, memiliki ketepatan kadar yang sesuai persyaratan, dan menunjukkan profil pelarutan zat aktif yang cepat.
Hypertension is a chronic disease with a high prevalence and is often referred to as a silent killer due to its potential to cause fatal complications when inadequately controlled. Propranolol hydrochloride is commonly used in antihypertensive therapy; however, conventional tablet dosage forms may pose swallowing difficulties for geriatric patients and individuals with dysphagia. To improve patient compliance and convenience, an orodispersible film (ODF) formulation of Propranolol HCl that rapidly dissolves in the oral cavity without the need for water was developed.
This study aimed to optimize the combination of hydroxypropyl methylcellulose (HPMC) and sodium carboxymethylcellulose (CMC-Na) as film-forming polymers and to evaluate the drug content and dissolution profile of optimum ODF formulation. The films were prepared using the solvent casting method, and formulation optimization was conducted using a Simplex Lattice Design (SLD) approach with Design-Expert software. The prepared films were evaluated for organoleptic properties, weight, thickness, pH, folding endurance, disintegration time, drug content, and dissolution profile.
The results demonstrated that the optimum ODF formulation was achieved with a polymer combination of 1,290% HPMC and 0,202 CMC-Na. This formulation exhibited a film weight of 0.090±0,003 g, thickness of 0.037±0,011 mm, folding endurance exceeding 500 folds, pH of 6.69±0,084, and a disintegration time of 12.96±0,797 seconds. Drug content analysis revealed an active ingredient content of 19.719 mg per film, while the dissolution test showed that 94.799% of Propranolol HCl was released within 15 minutes. In conclusion, the combination of HPMC and CMC-Na successfully produced an orodispersible film of Propranolol HCl that met the required physical quality standards, had the required content accuracy, and exhibited a rapid dissolution profile of the active substance.
Kata Kunci :
hipertensi, orodispersible film, propranolol, HPMC, CMC-Na
