跳到主要內容

臺灣博碩士論文加值系統

(216.73.216.227) 您好!臺灣時間:2026/05/16 00:30
字體大小: 字級放大   字級縮小   預設字形  
回查詢結果 :::

詳目顯示

我願授權國圖
: 
twitterline
研究生:墜子偉
研究生(外文):Zi-Wei Chui
論文名稱:Ibuprofen 400mg 直接打錠之處方與製程設計
論文名稱(外文):Prescription and process design of Ibuprofen 400mg direct compress tablet
指導教授:連金城連金城引用關係
指導教授(外文):Jin-Cherng Lien
學位類別:碩士
校院名稱:中國醫藥大學
系所名稱:製藥碩士學位學程
學門:醫藥衛生學門
學類:藥學學類
論文種類:學術論文
論文出版年:2021
畢業學年度:109
語文別:中文
論文頁數:49
中文關鍵詞:直接打錠非固醇類止痛藥異布洛芬
外文關鍵詞:direct compress tabletNSAIDIbuproen
相關次數:
  • 被引用被引用:0
  • 點閱點閱:500
  • 評分評分:
  • 下載下載:0
  • 收藏至我的研究室書目清單書目收藏:0
口服錠劑是世界上最常見的服藥形式,這包含許多好處,如:易於吸收和攜帶,生產成本低,我們服用藥物或藥劑師調配處方時能夠確保劑量。遺憾的是,濕法制粒法生產片劑的工序太多,包括:篩料、混合、製粒、製粒後篩料、乾燥、乾燥後篩料、最終的混合和壓片,這是一個很大的問題。為了縮短工程並降低製造成本,通過直接打定生產口服片劑是最佳選擇,因為它只有三個步驟:篩料、混合和壓片。另一方面,布洛芬,一種NSAID(非類固醇抗炎劑)。藥物)用於通過口服片劑的形式治療疼痛和炎症。然而,布洛芬片劑很容易吸收,因為熔點低,所以很難製造。為了克服這些困難,我們找出了直接壓片的處方,該處方具有優異的產率,硬度,高效的溶離和良好的測定性能。
為了使處方更好,我們選擇了脫模劑、粘合劑、潤滑劑等合適的直接打錠成分,並對這些成分的性質進行了測試。最後,以微晶纖維素作為粘結劑,aerosil-200為潤滑劑,硬脂酸鎂為脫模劑,確定了最佳配方。
The dosage of oral tableting is the most common form on the earth and contains many benefits, such as: easy to uptake and carry, low cost of production, and insure the dosage when we take or prescription by a pharmacist. Unfortunately, it is a big problem that a tablet is produced via too many procedures by wet granulation method, including: sieving, blending, granulation, wet screening, drying, dry screening, final mixing, and compression. For shorten the procedures and reducing the manufacturing cost, it is the best choice to producing an oral tablet by direct compress because it only three steps: sieving, blending, and compression. In the other hand, ibuprofen, a kind of NSAID (non-steroidal anti- inflammatory. Drug) is used for treating pain and inflammation by oral tableting form. However, the ibuprofen tablet is easy to uptake but hard to be made because of the low melting point.
To overcome the difficulties, we figured out the prescription of direct compress tableting with excellent yield, hardness, high dissolution, and good assay. To make the prescription better, we choose suitable ingredients of the direct compression tablet included lubricant, binder, anticaking agent, and tested the value of those compositions. Finally, the formulation we developed is: microcrystalline cellulose as a binder, aerosil 200 as an anticaking agent, magnesium stearate as a lubricant and found the best value of the formulation with excellent yield, hardness, high dissolution, and good assay.
目錄
表目錄VII
圖目錄VIII
第一章 緒論1
第一節 藥劑的起源1
第二節 口服錠劑的好處1
第三節 錠劑的分類2
第四節 錠劑的製備6
第五節 主要原料的特性13
第六節 壓縮指標&豪斯納比率(Hausner ratio)18
第二章 研究動機與目的20
第三章 實驗部分21
第一節 材料與儀器21
第二節 研究方法23
第四章 結果與討論25
第五章 結論38
第六章 參考資料40

1.W.Dittert L. 藥劑學(下冊). 華雄圖書有限公司; 1986.
2.Buddhadev MD, Patel KS, Patel VJ, Bhatt SP, Deshpande SS. Perceptions about oral liquid medication dosing devices and dosing. Journal of Pharmacy Research. 2016;10(12):810-3.
3.Gaikwad SS, Kshirsagar SJ. Review on Tablet in Tablet techniques. Beni-Suef University Journal of Basic and Applied Sciences. 2020 2020/01/02;9(1):1.
4.Dasari T, Kala S, Nadendla R. In process quality control tests of solid dosage forms : a comprehensive review. 2017; 2017.
5.Bandelin FJ. Compressed tablets by wet granulation. Pharmaceutical dosage forms: tablets. 1989;1:131-93.
6.Robinson JR, McGinity JW. Effervescent granules and methods for their preparation. Google Patents; 2000.
7.Salamat-Miller N, Chittchang M, Johnston TP. The use of mucoadhesive polymers in buccal drug delivery. Adv Drug Deliv Rev. 2005 Nov 3;57(11):1666-91.
8.Vyas S, Khar R. Controlled drug delivery : Concepts and advances: Vallabh Prakashan; 2002.
9.Kalyani S, Chilkawar RN, Nanjwade BK, Giriyappa RS, Ganechar P. Design and Characterization of Buccal Tablet of Montelukast Sodium. WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES. 2015;4(5):977-92.
10.Goh HP, Heng PWS, Liew CV. Comparative evaluation of powder flow parameters with reference to particle size and shape. Int J Pharm. 2018 Aug 25;547(1-2):133-41.
11.Kachrimanis K, Petrides M, Malamataris S. Flow rate of some pharmaceutical diluents through die-orifices relevant to mini-tableting. Int J Pharm. 2005 Oct 13;303(1-2):72-80.
12.Sandler N, Wilson D. Prediction of granule packing and flow behavior based on particle size and shape analysis. J Pharm Sci. 2010 Feb;99(2):958-68.
13.Kazemi P, Khalid MH, Pérez Gago A, Kleinebudde P, Jachowicz R, Szlęk J, et al. Effect of roll compaction on granule size distribution of microcrystalline cellulose-mannitol mixtures: computational intelligence modeling and parametric analysis. Drug Des Devel Ther. 2017;11:241-51.
14.Gluba T, Obraniak A, Gawot-Młynarczyk E. The effect of granulation conditions on bulk density of a product. Physicochemical Problems of Mineral Processing. 2004;38:177-86.
15.Ullmann P. Excipient selection for compounded pharmaceutical capsules: they''re only fillers, right? Australian Journal of Pharmacy. 2017;98(1164):78-83.
16.Grodowska K, Parczewski A. Organic solvents in the pharmaceutical industry. Acta Pol Pharm. 2010 Jan-Feb;67(1):3-12.
17.Antony PJ, Sanghavi NM. A New Disintegrant for Pharmaceutical Dosage Forms. Drug Development and Industrial Pharmacy. 1997 1997/01/01;23(4):413-5.
18.Li J, Wu Y. Lubricants in Pharmaceutical Solid Dosage Forms. Lubricants. 2014;2(1):21-43.
19.Bushra R, Shoaib MH, Aslam N, Hashmat D, Rehman M. Formulation development and optimization of ibuprofen tablets by direct compression method. Pak J Pharm Sci. 2008;21(2):113-20.
20.Parikh DM. Handbook of pharmaceutical granulation technology: CRC Press; 2016.
21.Vasanthavada M, Wang Y, Haefele T, Lakshman JP, Mone M, Tong W, et al. Application of melt granulation technology using twin-screw extruder in development of high-dose modified-release tablet formulation. Journal of pharmaceutical sciences. 2011;100(5):1923-34.
22.Tousey MD. The granulation process 101. Basic Technologies for Tablet Making, Available from pharmtech com. 2013.
23.Kristensen HG, Schaefer T. Granulation: A review on pharmaceutical wet-granulation. Drug development and industrial pharmacy. 1987;13(4-5):803-72.
24.Shanmugam S. Granulation techniques and technologies: recent progresses. BioImpacts: BI. 2015;5(1):55.
25.Shinde N, Aloorkar N, Kulkarni A, Bangar B, Sulake S, Kumbhar P. Recent advances in granulation techniques. Asian Journal of Research in Pharmaceutical Science. 2014;4(1):38-47.
26.Kleinebudde P. Roll compaction/dry granulation: pharmaceutical applications. European Journal of Pharmaceutics and biopharmaceutics. 2004;58(2):317-26.
27.Codex P. Principles and practice of pharmaceutics. The Pharmaceutical Press London Edition. 1994;12:84-90.
28.Martino P, Joiris E, Martelli S. Particle interaction of lubricated or un lubricated binary mixtures according to their particle size and densification mechanism II. Farmaco. 2004;59(9):747-58.
29.Bushra R, Aslam N. An overview of clinical pharmacology of Ibuprofen. Oman medical journal. 2010;25(3):155.
30.Han X, Ghoroi C, To D, Chen Y, Davé R. Simultaneous micronization and surface modification for improvement of flow and dissolution of drug particles. International journal of pharmaceutics. 2011;415(1-2):185-95.
31.Irvine J, Afrose A, Islam N. Formulation and delivery strategies of ibuprofen: challenges and opportunities. Drug Dev Ind Pharm. 2018 Feb;44(2):173-83.
32.Abraham P, Indirani K, Desigamani K. Nitro-arginine methyl ester, a non-selective inhibitor of nitric oxide synthase reduces ibuprofen-induced gastric mucosal injury in the rat. Digestive diseases and sciences. 2005;50(9):1632-40.
33.Rainsford K. Ibuprofen: pharmacology, efficacy and safety. Inflammopharmacology. 2009;17(6):275-342.
34.Wahbi AA, Hassan E, Hamdy D, Khamis E, Barary M. Spectrophotometric methods for the determination of Ibuprofen in tablets. Pakistan journal of pharmaceutical sciences. 2005;18(4):1-6.
35.Stott PW, Williams AC, Barry BW. Transdermal delivery from eutectic systems: enhanced permeation of a model drug, ibuprofen. Journal of controlled release. 1998;50(1-3):297-308.
36.Liu L, Marziano I, Bentham A, Litster J, White E, Howes T. Effect of particle properties on the flowability of ibuprofen powders. International journal of pharmaceutics. 2008;362(1-2):109-17.
37.Hersh EV, Pinto A, Moore PA. Adverse drug interactions involving common prescription and over-the-counter analgesic agents. Clinical therapeutics. 2007;29(11):2477-97.
38.Hersh EV, Moore PA, Ross GL. Over-the-counter analgesics and antipyretics: a critical assessment. Clinical therapeutics. 2000;22(5):500-48.
39.Milsom I, Minic M, Dawood MY, Akin MD, Spann J, Niland NF, et al. Comparison of the efficacy and safety of nonprescription doses of naproxen and naproxen sodium with ibuprofen, acetaminophen, and placebo in the treatment of primary dysmenorrhea: a pooled analysis of five studies. Clinical therapeutics. 2002;24(9):1384-400.
40.Graham G, Williams K. Metabolism and pharmacokinetics of ibuprofen. Aspirin and related drugs Taylor & Francis, London. 2004:157-80.
41.Marchessault R, Sundararajan P. Cellulose.The polysaccharides: Elsevier; 1983. p. 11-95.
42.Atalla RH, Vanderhart DL. Native cellulose: a composite of two distinct crystalline forms. Science. 1984;223(4633):283-5.
43.Goda K, Sreekala M, Gomes A, Kaji T, Ohgi J. Improvement of plant based natural fibers for toughening green composites—Effect of load application during mercerization of ramie fibers. Composites Part A: Applied science and manufacturing. 2006;37(12):2213-20.
44.Trache D, Hussin MH, Chuin CTH, Sabar S, Fazita MN, Taiwo OF, et al. Microcrystalline cellulose: Isolation, characterization and bio-composites application—A review. International Journal of Biological Macromolecules. 2016;93:789-804.
45.Hausner HH. Friction conditions in a mass of metal powder: Polytechnic Inst. of Brooklyn. Univ. of California, Los Angeles; 1967.
46.Bacher C, Olsen P, Bertelsen P, Sonnergaard J. Compressibility and compactibility of granules produced by wet and dry granulation. International journal of pharmaceutics. 2008;358(1-2):69-74.
47.Carr RL. Evaluating flow properties of solids. Chem Eng. 1965;18:163-8.
48.Sherwood BE, Staniforth JH, Hunter EA. Pharmaceutical excipient having improved compressibility. Google Patents; 2000.
49.Ohrem HL, Schornick E, Kalivoda A, Ognibene R. Why is mannitol becoming more and more popular as a pharmaceutical excipient in solid dosage forms? Pharmaceutical development and technology. 2014;19(3):257-62.
50.Paul S, Sun CC. Lubrication with magnesium stearate increases tablet brittleness. Powder Technology. 2017;309:126-32.
51.Kikuta J-I, Kitamori N. Effect of mixing time on the lubricating properties of magnesium stearate and the final characteristics of the compressed tablets. Drug development and industrial pharmacy. 1994;20(3):343-55.
52.Staniforth J. Powder flow. Pharmaceutics, The science of dosage form design. 2002:197-210.
53.黃安婗. 不要再瞎攪和了. 科學發展. 2015;513:24-9.
54.Convention TUSP. The United States Pharmacopeia; 2018
電子全文 電子全文(全文開放日期20260713,本篇電子全文限研究生所屬學校校內系統及IP範圍內開放)
QRCODE
 
 
 
 
 
                                                                                                                                                                                                                                                                                                                                                                                                               
第一頁 上一頁 下一頁 最後一頁 top