Adegbolagun Tioluwani Ibukun, Odeniyi Olubusola Ayoola, Odeniyi Michael Ayodele
Department of Pharmaceutics and Industrial Pharmacy, University of Ibadan, Nigeria.
Department of Microbiology, University of Ibadan, Nigeria.
Polim Med. 2025 Jan-Jun;55(1):7-19. doi: 10.17219/pim/202946.
Oral dissolving films are portable dosage forms that consist of active pharmaceutical ingredients incorporated into film-forming polymers such as starch. Starches obtain optimum filmogenic properties by gelatinization and blending with other polymers. The high starch content of bitter yam (Dioscorea dumetorum Pax) gives it yet unexplored potential for orodispersible films.
This study aimed to investigate the effect of pregelatinization on the physicochemical properties of bitter yam starch. Additionally, our objective was to evaluate the potential of both native starch (NS) and pregelatinized starch (PS), incorporated into polymer blends, as biopolymeric materials for use in orally dissolving films (ODFs).
Native and pregelatinized wild Dioscorea dumetorum Pax (bitter yam) starch were prepared and characterized using physicochemical, microscopic and rheological methods, Fourier-transform infrared spectroscopy, X-ray diffractometry (XRD), and differential scanning calorimetry (DSC). Oral dissolving films with varying hydroxylpropylmethyl cellulose (HPMC)-to-starch ratios (1:1, 1:2 and 2:1) were formulated and evaluated based on organoleptic properties, surface morphology, folding endurance, weight and thickness, pH, and disintegration time.
Pregelatinization improved the swelling, solubility and hydration capacity of the starch. Although no changes were observed in the crystalline nature upon gelatinization, DSC analysis revealed remarkable changes in the thermal behavior of the NS after pregelatinization. Both NS and PS did not produce continuous films without HPMC. Flexibility of the starch increased with increasing HPMC concentration films, and PS-based films had higher folding endurance compared to NS films. Native starch-based films had smoother surfaces and higher thicknesses than PS films. All the starch films demonstrated disintegration times longer than 15 min, and slightly acidic pH values.
Pregelatinization of bitter yam starch, followed by blending with HPMC at a 2:1 ratio, resulted in the most effective oral film formulation. Further studies focusing on optimizing disintegration rates and pH would help confirm the suitability of this starch for use in ODF formulations.
口腔速溶膜是一种便携式剂型，由活性药物成分与成膜聚合物（如淀粉）混合而成。淀粉通过糊化以及与其他聚合物共混获得最佳的成膜性能。苦山药（薯蓣属植物）的高淀粉含量使其在口腔崩解膜方面具有尚未被探索的潜力。
本研究旨在探究预糊化对苦山药淀粉理化性质的影响。此外，我们的目的是评估天然淀粉（NS）和预糊化淀粉（PS）作为聚合物共混物掺入后作为用于口腔速溶膜（ODF）的生物聚合物材料的潜力。
制备天然和预糊化的野生薯蓣属植物（苦山药）淀粉，并使用理化、显微镜和流变学方法、傅里叶变换红外光谱、X射线衍射（XRD）和差示扫描量热法（DSC）对其进行表征。制备了不同羟丙基甲基纤维素（HPMC）与淀粉比例（1:1、1:2和2:1）的口腔速溶膜，并基于感官特性、表面形态、耐折性、重量和厚度、pH值以及崩解时间进行评估。
预糊化改善了淀粉的膨胀性、溶解性和水合能力。虽然糊化后结晶性质未观察到变化，但DSC分析显示预糊化后NS的热行为发生了显著变化。没有HPMC时，NS和PS都不能形成连续的膜。随着HPMC浓度增加，淀粉膜的柔韧性增加，与NS膜相比，基于PS的膜具有更高的耐折性。基于天然淀粉的膜比PS膜具有更光滑的表面和更高的厚度。所有淀粉膜的崩解时间均超过15分钟，且pH值呈微酸性。
苦山药淀粉预糊化后，以比例2:1与HPMC共混，可得到最有效的口腔膜制剂。进一步聚焦于优化崩解速率和pH值的研究将有助于确认这种淀粉用于ODF制剂的适用性。
