Maltodextrin: a novel excipient used in sugar-based orally disintegrating tablets and phase transition process.
The recent challenge in orally disintegrating tablets (ODT) manufacturing encompasses the compromise between instantaneous disintegration, sufficient hardness, and standard processing equipment. The current investigation constitutes one attempt to fulfill this challenge. Maltodextrin, in the present work, was utilized as a novel excipient to prepare ODT of meclizine. Tablets were prepared by both direct compression and wet granulation techniques. The effect of maltodextrin concentrations on ODT characteristics--manifested as hardness and disintegration time--was studied. The effect of conditioning (40 degrees C and 75% relative humidity) as a post-compression treatment on ODT characteristics was also assessed. Furthermore, maltodextrin-pronounced hardening effect was investigated using differential scanning calorimetry (DSC) and X-ray analysis. Results revealed that in both techniques, rapid disintegration (30-40 s) would be achieved on the cost of tablet hardness (about 1 kg). Post-compression conditioning of tablets resulted in an increase in hardness (3 kg), while keeping rapid disintegration (30-40 s) according to guidance of the FDA for ODT. However, direct compression-conditioning technique exhibited drawbacks of long conditioning time and appearance of the so-called patch effect. These problems were, yet, absent in wet granulation-conditioning technique. DSC and X-ray analysis suggested involvement of glass-elastic deformation in maltodextrin hardening effect. High-performance liquid chromatography analysis of meclizine ODT suggested no degradation of the drug by the applied conditions of temperature and humidity. Overall results proposed that maltodextrin is a promising saccharide for production of ODT with accepted hardness-disintegration time compromise, utilizing standard processing equipment and phenomena of phase transition.
Elnaggar
Yosra Shaaban R
YS
Department of Pharmaceutics, Faculty of Pharmacy, University of Alexandria, 1 Khartoum Square, Azarita, Messalla Post Office, P. O. Box 21521, Alexandria, Egypt. yosra_pharm@yahoo.com
El-Massik
Magda A
MA
Abdallah
Ossama Y
OY
Ebian
Abd Elazim R
AE
D000284:Administration, Oral; D002241:Carbohydrates / Q000737:chemistry; D019245:Compressive Strength; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000138:chemical synthesis*; D004339:Drug Compounding / Q000379:methods; D004355:Drug Stability; D005079:Excipients / Q000737:chemistry*; D006244:Hardness; D044367:Phase Transition; D011134:Polysaccharides / Q000737:chemistry*; D013607:Tablets
D002241:Carbohydrates; D003692:Delayed-Action Preparations; D005079:Excipients; D011134:Polysaccharides; D013607:Tablets; C008315:maltodextrin
J Pharm Pharmacol. 1990 Apr;42(4):272-5
1974296
Clin Ther. 2008 Nov;30(11):2146-54
19108802
Int J Pharm. 2005 Dec 8;306(1-2):83-90
16257154
Eur J Pharm Biopharm. 2009 May;72(1):119-29
19073253
Int J Pharm. 2009 Jan 21;366(1-2):149-53
18848869
Chem Pharm Bull (Tokyo). 1996 Nov;44(11):2121-7
8945778
Int J Pharm. 2005 May 30;296(1-2):64-72
15885456
Eur Neuropsychopharmacol. 2007 Dec;17(12):743-55
17624740
J Pharm Sci. 1999 Oct;88(10):1004-10
10514347
J Control Release. 2005 Jun 20;105(1-2):16-22
15955365
Eur J Pharm Biopharm. 2008 Aug;69(3):986-92
18396020
Int J Pharm. 2008 Jul 9;359(1-2):63-9
18455893
Eur J Pharm Biopharm. 2008 Jun;69(2):727-34
18226885
Neurotherapeutics. 2008 Apr;5(2):164-80
18394561
Eur J Pharm Biopharm. 2008 May;69(1):335-41
18182280