PMID- 22101283
OWN - NLM
STAT- MEDLINE
DCOM- 20120427
LR  - 20171116
IS  - 1873-3476 (Electronic)
IS  - 0378-5173 (Linking)
VI  - 422
IP  - 1-2
DP  - 2012 Jan 17
TI  - Effect of disintegrants on the properties of multiparticulate tablets comprising 
      starch pellets and excipient granules.
PG  - 310-7
LID - 10.1016/j.ijpharm.2011.11.017 [doi]
AB  - A design of experiments (DOE) approach (2-level full factorial design) was used 
      to investigate the effect of several formulation and process variables on the 
      properties of fast disintegrating tablets comprising starch-based pellets and 
      excipient granules and to optimize and validate the design space. The percentage 
      of starch pellets (30-50%, w/w), type of disintegrants (Ac-di-sol, Explotab, 
      Polyplasdone), percentage of external disintegrant (4-8%, w/w) and compression 
      force (5-15 kN) were the evaluated factors (24 runs+9 centre points=33 
      experiments), while tablet hardness, friability and disintegration time were the 
      studied tablet properties (responses). Starch pellets were prepared by 
      extrusion-spheronisation. Excipient granules containing microcrystalline 
      cellulose, lactose, internal disintegrant (8%) and polyvinylpyrrolidone K-30 (4%) 
      were prepared by wet granulation. Pellets, granules (700-1000 mum) and external 
      disintegrant were mixed and compressed into oblong tablets (17.1mm long, 8.2mm 
      wide). Evaluation of the effects calculated from the DOE results showed that a 
      lower concentration of starch pellets and higher compression force were required 
      to yield tablets with a high hardness, a low friability (<1%) and short 
      disintegration time (<3 min). Polyplasdone granules had the lowest porosity and 
      friability which was reflected in the DOE study, where the 
      Polyplasdone-containing tablets were harder, less friable and disintegrated 
      faster compared to Ac-di-sol and Explotab-containing tablets. Monte carlo 
      simulations at the optimal factor settings (30% starch pellets, 4% Polyplasdone 
      and 10 kN compression force) indicated that a robust system was formed as the 
      probability to exceed the limits was low for all responses. Validation of the 
      design space (at optimal settings) showed that the results predicted via the DOE 
      models correlated well with the observed experimental data.
CI  - Copyright (c) 2011 Elsevier B.V. All rights reserved.
FAU - Mehta, Samata
AU  - Mehta S
AD  - Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, 
      Ghent B-9000, Belgium.
FAU - De Beer, Thomas
AU  - De Beer T
FAU - Remon, Jean Paul
AU  - Remon JP
FAU - Vervaet, Chris
AU  - Vervaet C
LA  - eng
PT  - Journal Article
DEP - 20111111
PL  - Netherlands
TA  - Int J Pharm
JT  - International journal of pharmaceutics
JID - 7804127
RN  - 0 (Excipients)
RN  - 0 (Powders)
RN  - 0 (Tablets)
RN  - 9004-34-6 (Cellulose)
RN  - 9005-25-8 (Starch)
RN  - 9063-38-1 (sodium starch glycolate)
RN  - FZ989GH94E (Povidone)
RN  - OP1R32D61U (microcrystalline cellulose)
SB  - IM
MH  - Cellulose/chemistry
MH  - Chemistry, Pharmaceutical
MH  - Compressive Strength
MH  - Drug Compounding
MH  - Excipients/*chemistry
MH  - Hardness
MH  - Kinetics
MH  - Porosity
MH  - Povidone/*chemistry
MH  - Powders
MH  - Solubility
MH  - Starch/*analogs & derivatives/*chemistry
MH  - Tablets
MH  - Technology, Pharmaceutical/methods
EDAT- 2011/11/22 06:00
MHDA- 2012/04/28 06:00
CRDT- 2011/11/22 06:00
PHST- 2011/07/05 00:00 [received]
PHST- 2011/09/09 00:00 [revised]
PHST- 2011/11/07 00:00 [accepted]
PHST- 2011/11/22 06:00 [entrez]
PHST- 2011/11/22 06:00 [pubmed]
PHST- 2012/04/28 06:00 [medline]
AID - S0378-5173(11)01055-6 [pii]
AID - 10.1016/j.ijpharm.2011.11.017 [doi]
PST - ppublish
SO  - Int J Pharm. 2012 Jan 17;422(1-2):310-7. doi: 10.1016/j.ijpharm.2011.11.017. Epub 
      2011 Nov 11.