Chen Qingqing, Martin Russell, Hoag Stephen W, Wood Robert A, Mao Hai-Quan, Keet Corinne
Department of Materials Science and Engineering, Whiting School of Engineering, Johns Hopkins University, 3400 North Charles Street, Baltimore, MD 21218.
School of Pharmacy, University of Maryland at Baltimore, 20 North Pine Street, Baltimore, MD 21201.
Int J Pharma Sci. 2014 Sep-Oct;4(5):730-735.
Allergy and asthma are among the most common chronic diseases of childhood. Cockroach allergy is an important contributor to asthma morbidity, with a prevalence of 17 to 41%. Immunotherapy has been shown to be an effective treatment for other allergies that contribute to asthma, but several factors have limited its use for cockroach allergy. In this work, a sublingual immunotherapy (SLIT) formulation of orally dissolving thin film has been developed for the treatment of hypersensitivity to the German cockroach Bla g 2 allergen. The formulation allows for the incorporation of up to 25 μg/film of the allergen protein, and the film's mucoadhesiveness prolongs the effect of the allergen with the potential for enhanced efficacy. The potency and dose uniformity of the SLIT formulation were characterized by enzyme-linked immunosorbent assay (ELISA), and other physicochemical properties were evaluated by spectroscopic or mechanistic methods. The films were uniform in weight and thickness, and demonstrated substantial physical strength to allow easy manipulation during manufacturing and dosing. The dosage uniformity, in vitro disintegration and in vitro dissolution profiles of the films were within the acceptance criteria in the United States Pharmacopeia. The developed SLIT methodology possesses the potential to significantly improve immunotherapy for both food and inhalant allergies in adults and children.
过敏和哮喘是儿童期最常见的慢性病。蟑螂过敏是导致哮喘发病的一个重要因素，患病率为17%至41%。免疫疗法已被证明是治疗其他导致哮喘的过敏症的有效方法，但有几个因素限制了其在蟑螂过敏治疗中的应用。在这项研究中，已开发出一种用于治疗对德国小蠊变应原Bla g 2过敏的舌下免疫疗法（SLIT）口腔崩解薄膜制剂。该制剂每片可容纳高达25μg的变应原蛋白，薄膜的粘膜粘附性可延长变应原的作用时间，有可能提高疗效。通过酶联免疫吸附测定（ELISA）对SLIT制剂的效价和剂量均匀性进行了表征，并通过光谱或机械方法评估了其他物理化学性质。这些薄膜重量和厚度均匀，具有足够的物理强度，便于在生产和给药过程中进行操作。薄膜的剂量均匀性、体外崩解和体外溶出曲线均符合美国药典的验收标准。所开发的SLIT方法有潜力显著改善成人和儿童食物及吸入性过敏的免疫疗法。
