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Effect of different molecular weights of polyethylene glycol as a plasticizer on the formulation of dry powder inhaler capsules: Investigation of puncturing size,morphologies, and surface properties
Institution:1. Iran Gelatin Capsule mfg Co, 3351773415 Tehran, Iran;2. Department of Biotechnology, Faculty of Advanced Technologies in Medicine, Iran University of Medical Sciences, 1449614535 Tehran, Iran;3. Chemical and Petroleum Engineering Department, Sharif University of Technology, 14588-89694 Tehran, Iran
Abstract:Today, the principle of research and development is pulmonary drug delivery due to the potential for maximizing therapeutic effects for patients by direct drug targeting the pathology site in the lungs. Amongst the convenient delivery alternatives, the Dry Powder Inhaler (DPI) is the preferred device to remedy a variety of diseases. In this regard, the fabrication and development of a novel formulation for DPI capsules have been studied. We investigated the effects of various parameters, such as percentages of polyethylene glycol (PEG), propylene glycol (PG), glycerol (Gly), brittleness, test conditions, and particle release of manufactured DPI capsules. The efficacy of each parameter was evaluated in detail to understand and address the consequences of the mentioned factors. The results illustrated that the lower molecular weight of PEGs presented the better plasticizing capability of gelatin. Owing to the hygroscopicity of the utilized plasticizer, polyethylene glycol 400 (PEG 400) increased the capsule flexibility for a longer time and its stability under environmental conditions in the gelatin capsule formulation. Likewise, no particle release was observed in the gelatin/PEG capsule. The prepared gelatin/PEG400 capsules were compared with pure gelatin and HPMC capsules. The capsules were evaluated in terms of loss on drying (LOD), surface morphology, roughness, and puncture type. The results show that using PEG-400 can lead to the production of capsules that have low moisture content and minimal interaction with APIs. In addition, gelatin/PEG capsules have no particles due to the smooth surface after the punching process. The as-produced capsules are not blocked again after punching, allowing the patient to take the drug completely. In fact, the present research provided substantial insight regarding the development of DPI formulation in capsule investigations on an industrial scale.
Keywords:Capsule  Dry powder inhaler  Gelatin  Plasticizer  Poly Ethylene Glycol  Industrial scale
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