394
Views
1
CrossRef citations to date
0
Altmetric
Research Article

Optimizing a wet granulation process to obtain high-dose sustained-release tablets with Compritol 888 ATO

, , , &
Pages 1738-1744 | Received 25 Aug 2014, Accepted 20 Dec 2014, Published online: 05 Feb 2015

References

  • Tousey MD. The granulation process 101. Basic technologies for tablet making. 2002. Available from: http://www.pharmtech.com/pharmtech/data/articlestandard//pharmtech/432002/36208/article.pdf [last accessed 30 Apr 2014]
  • Bajdik J, Baki G, Kelemen A, Pintye-Hódi K. The effect of wetting of powder mixture on the preparation of hydrophilic matrix granules with high-shear granulator. Chem Eng Res Des 2008;86:1–7
  • Jeon I, Gilli T, Betz G. Evaluation of roll compaction as a preparation method for hydroxypropyl cellulose-based matrix tablets. J Pharm Bioallied Sci 2011;3:213–20
  • Shah NH, Railkar AS, Phuapradit W, et al. Effect of processing techniques in controlling the release rate and mechanical strength of hydroxypropyl methylcellulose based hydrogel matrices. Eur J Pharm Biopharm 1996;42:183–7
  • Grodowska K, Parczewski A. Organic solvents in the pharmaceutical industry. Acta Pol Pharm 2010;67:3–12
  • Agrawal AM, Neau SH, Bonate PL. Wet granulation fine particle ethylcellulose tablets: effect of production variables and mathematical modeling of drug release. AAPS PharmSci 2003;5:48–60
  • Khan GM, Meidan VM. Drug release kinetics from tablet matrices based upon ethylcellulose ether-derivatives: a comparison between different formulations. Drug Dev Ind Pharm 2007;33:627–39
  • Kiortsis S, Kachrimanis K, Broussali T, Malamataris S. Drug release from tableted wet granulations comprising cellulosic (HPMC or HPC) and hydrophobic component. Eur J Pharm Biopharm 2005;59:73–83
  • Chaudhary A, Pacharane S, Jadhav KR, Kadam VJ. Formulation and development of extended release tablet of lamotrigine. Int J Pharam Bio Sci 2011;2:198–210
  • Korbely A, Kelemen A, Kasa P Jr, Pintye-Hodi K. Effects of processing on the release profiles of matrix systems containing 5-aminosalicylic acid. AAPS PharmSciTech 2012;13:1341–7
  • Lin SY, Lin KH, Li MJ. Formulation design of double-layer in the outer shell of dry-coated tablet to modulate lag time and time-controlled dissolution function: studies on micronized ethylcellulose for dosage form design (VII). AAPS J 2004;6:1–6
  • Quinten T, Andrews GP, De Beer T, et al. Preparation and evaluation of sustained-release matrix tablets based on metoprolol and an acrylic carrier using injection moulding. AAPS PharmSciTech 2012;13:1197–211
  • Pollock D, Balwinski K. Aqueous granulation of an ethylcellulose containing inert matrix formulation. Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists; 1997; Boston, MA, USA, published in August 2002
  • Zhang YE, Tchao R, Schwartz JB. Effect of processing methods and heat treatment on the formation of wax matrix tablets for sustained drug release. Pharm Dev Technol 2001;6:131–44
  • Gu X, Fediuk DJ, Simons FER, Simons KJ. Evaluation and comparison of five matrix excipients for the controlled release of acrivastine and pseudoephedrine. Drug Dev Ind Pharm 2004;30:1009–17
  • Barakat NS, Elbagory IM, Almurshedi AS. Controlled-release carbamazepine granules and tablets comprising lipophilic and hydrophilic matrix components. AAPS PharmSciTech 2008;9:1054–62
  • Barakat NS, Elbagory IM, Almurshedi AS. Controlled-release carbamazepine matrix granules and tablets comprising lipophilic and hydrophilic components. Drug Deliv 2009;16:57–65
  • Gu X, Fediuk DJ, Simons FE, Simons KJ. Evaluation and comparison of five matrix excipients for the controlled release of acrivastine and pseudoephedrine. Drug Dev Ind Pharm 2004;30:1009–17
  • Patere SN, Desai NS, Jain AS, et al. Compritol(R)888 ATO a lipid excipient for sustained release of highly water soluble active: formulation, scale-up and IVIVC study. Curr Drug Deliv 2013;10:548–56
  • Fell JT, Newton JM. The tensile strength of lactose tablets. J Pharm Pharmacol 1968;20:657–9
  • Moore JW, Flanner HH. Mathematical comparison of curves with an emphasis on in vitro dissolution profiles. Pharm Tech 1996;20:64–74
  • Rojas JJ, Aristizabal J, Henao M. Screening of several excipients for direct compression of tablets: a new perspective based on functional properties. Rev Ciênc Farm Básica Apl 2013;34:17–23
  • Sunovion Pharmaceuticals Canada Inc. Niaspan FCT product monograph. 2011. Available from: http://www.sunovion.ca/monographs/niaspanFCT.pdf [last accessed 30 Oct 2014]
  • Fu Y, Kao WJ. Drug release kinetics and transport mechanisms of non-degradable and degradable polymeric delivery systems. Expert Opin Drug Deliv 2010;7:429–44
  • Siepmann J, Siepmann F. Mathematical modeling of drug release from lipid dosage forms. Int J Pharm 2011;418:42–53
  • Velghe C, Rosiaux Y, Marchaud D, et al. In silico simulation of niacin release from lipid tablets: theoretical predictions and independent experiments. J Control Release 2014;175:63–71
  • Rosiaux Y, Desvignes F, Girard JM, et al. The effect of the process on drug release of Compritol®888 sustained release tablets: direct compression, wet granulation and hot melt extrusion (Abstract no: 10515). 41st Annual Meeting & Exposition of the Controlled Release Society; 2014 July 13–16; Chicago
  • Nokhodchi A. An overview of the effect of moisture on compaction and compression. 2005. Available from: http://www.pharmtech.com/pharmtech/data/articlestandard//pharmtech/022005/141826/article.pdf [last accessed 30 Apr 2014]
  • Rambali B, Baert L, Thone D, Massart DL. Using experimental design to optimize the process parameters in fluidized bed granulation. Drug Dev Ind Pharm 2001;27:47–55
  • Tomuta I, Alecu C, Rus LL, Leucuta SE. Optimization of fluid bed formulations of metoprolol granules and tablets using an experimental design. Drug Dev Ind Pharm 2009;35:1072–81
  • Bouffard J, Kaster M, Dumont H. Influence of process variable and physicochemical properties on the granulation mechanism of mannitol in a fluid bed top spray granulator. Drug Dev Ind Pharm 2005;31:923–33
  • Tardos GI, Khan MI, Mort PR. Critical parameters and limiting conditions in binder granulation of fine powders. Powder Technol 1997;94:245–58
  • De Boer AH, Vromans H, Lerk CF, et al. Studies on tableting properties of lactose: part III. The consolidation behaviour of sieve fractions of crystalline alpha-lactose monohydrate. Pharm Weekbl Sci 1986;8:145–50
  • Vromans H, de Boer AH, Bolhuis GK, et al. Studies on tabletting properties of lactose: part I. The effect of initial particle size on binding properties and dehydration characteristics of lactose. Acta Pharm Suec 1985;22:163–72

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.