Sublimation technique

升华技术
  • 文章类型: Journal Article
    目的:本研究工作旨在使用超级崩解剂和升华剂的组合来配制硫酸沙丁胺醇(SBS)的快速崩解片(FDTs),优化配方并评估开发的FDT的体外性能。
    方法:使用超级崩解剂-交聚维酮和升华剂-碳酸氢铵(AB)的组合开发了SBSFDT的配方,即交聚维酮和微晶纤维素(MCC)的水平:甘露糖醇(MNTL)比率评估了它们对响应变量-崩解时间的影响,硬度,所得FDT的脆性和润湿时间。通过采用中央复合设计(CCD)方法,优化FDT以达到配方因子的最佳水平。
    结果:在7.82%交聚维酮和70%的1.56:1MCC:MNTL比率下获得所需的最佳条件,同时出于美学原因将AB保持在5%水平。在优化条件下,崩解时间,硬度,脆性和润湿时间为14.57±0.53秒,7.17±0.82kg/cm2,0.311%和13.14±0.69秒,分别。发现实验观察到的响应与优化制剂的预测值非常一致。此外,所获得的最佳点的有效性被预测误差百分比的低幅度(<5%)所证实。
    结论:SBS的FDTs使用CCD使用超级崩解剂和升华剂的组合成功地配制和优化。
    OBJECTIVE: The present research work was aimed to formulate fast disintegrating tablets (FDTs) of salbutamol sulphate (SBS) using a combination of superdisintegrant and subliming agent, optimize the formulation and evaluate the in vitro performance of the developed FDTs.
    METHODS: A formulation of SBS FDT was developed using a combination of superdisintegrant - crospovidone and subliming agent - ammonium bicarbonate (AB) in which formulation variables, namely levels of crospovidone and microcrystalline cellulose (MCC):Mannitol (MNTL) ratio were evaluated for their effects on the response variables - disintegration time, hardness, friability and wetting time of the resulting FDTs. By employing a central composite design (CCD) methodology, the FDTs were optimized to achieve optimum levels of the formulation factors.
    RESULTS: The desired optimum condition was obtained at 7.82% crospovidone and 70% of 1.56:1 MCC: MNTL ratio while maintaining AB at 5% level for aesthetic reasons. Under the optimized conditions, the disintegration time, hardness, friability and wetting time were 14.57±0.53 sec, 7.17±0.82 kg/cm2, 0.311% and 13.14±0.69 sec, respectively. The experimentally observed responses were found to be in close agreement with the predicted values for the optimized formulation. Moreover, the validity of the obtained optimal point was confirmed by the low magnitude of percent prediction error (<5%).
    CONCLUSIONS: FDTs of SBS were successfully formulated and optimized using CCD employing a combination of superdisintegrant and subliming agents.
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  • 文章类型: Journal Article
    We sought to evaluate the safety and effectiveness of patient-specific ocular prostheses produced by three-dimensional (3D) printing and the sublimation technique. A comparison with prostheses produced using manual manufacturing methods was then performed.
    To confirm the biological and physiochemical safety, cytotoxicity, systemic acute toxicity, intradermal reaction, and skin sensitization tests were conducted according to the International Organization for Standardization guidelines. The compressive strength of the prostheses was also tested. Further, a case series of three patients who wore the 3D printed prostheses for more than eight hours daily for 4 weeks was executed. Self-assessments by these individuals using a questionnaire and safety evaluations focusing on the occurrence of conjunctival inflammation or allergic reactions according to the Cornea and Contact Lens Research Unit criteria by slit-lamp examination and similarity assessment were completed.
    The 3D printed ocular prostheses met the necessary qualifications per the biological and physiochemical safety tests, showing the absence of cytotoxicity, acute systemic toxicity, intradermal reactivity, and skin-sensitizing potency. Also, there was no difference in strength test results between previous ocular prostheses and the 3D printed ones. Self-assessment by the patients yielded satisfactory results, with no significant difference in the level of satisfaction reported for the 3D printed and previous handmade ocular prostheses. The 3D printed prosthesis did not trigger any side effects in the conjunctival sac and showed similar objective findings with respect to the color of the iris, sclera, and vessel patterns.
    Our study confirms the biologic and physiochemical safety of 3D-printed ocular prostheses created using computer-aided design technology and a sublimation technique. The patients\' questionnaires and the judgment of the ophthalmologists/ocularists showed that the 3D printed ocular prosthesis was acceptable in function and appearance through a case series report.
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  • 文章类型: Journal Article
    The present study aims to develop floating drug delivery system by sublimation of ammonium carbonate (AMC). The core tablets contain a model drug, hydrochlorothiazide, and various levels (i.e., 0-50% w/w) of AMC. The tablets were then coated with different amounts of the polyacrylate polymers (i.e., Eudragit® RL100, Eudragit® RS100, and the mixture of Eudragit® RL100 and Eudragit® RS100 at 1:1 ratio). The coated tablets were kept at ambient temperature (25°C) or cured at 70°C for 12 h before further investigation. The floating and drug release behaviors of the tablets were performed in simulated gastric fluid USP without pepsin at 37°C. The results showed that high amount of AMC induced the floating of the tablets. The coated tablets containing 40 and 50% AMC floated longer than 8 h with a time-to-float of about 3 min. The sublimation of AMC from the core tablets decreased the density of system, causing floating of the tablets. The tablets coated with Eudragit® RL100 floated at a faster rate than those of Eudragit® RS100. Even the coating level of polymer did not influence the time-to-float and floating time of coated tablets containing the same amount of AMC, the drug release from the tablets coated with higher coating level of polymer showed slower drug release. The results suggested that the sublimation technique using AMC is promising for the development of floating drug delivery system.
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