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Comparison of drug release and mechanical properties of tramadol hydrochloride matrix tablets prepared with selected hydrophilic polymers

Poređenje oslobađanja tramadol-hidrohlorida i mehaničkih karakteristika matriks tableta izrađenih sa odabranim hidrofilnim polimerima

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2015
2350.pdf (453.2Kb)
Authors
Nikolić, Nenad D.
Medarević, Đorđe
Đuriš, Jelena
Vasiljević, Dragana
Article (Published version)
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Abstract
This study investigates the use of high molecular weight hydrophilic polymers, hypromellose and hydroxypropylcellulose, for the preparation of sustained release matrix tablets containing a high-dose highly soluble drug, tramadol HCl. The proportion of polymer, type of insoluble filler, proportion of tramadol HCl, amount of drug in the tablet and compression pressure were recognized as critical formulation and process parameters and their influence on drug release and tablet mechanical properties was evaluated. Tensile strength was used as an indicator of the mechanical properties of the tablets. Experiments were performed with utilization of a compaction simulator, a device that simulates compaction profiles of large scale rotary tablet presses. In formulations with both polymers, the proportion of tramadol HCl was the most critical formulation parameter, wherein increasing the proportion of tramadol HCl increased its release rate in the early stages of drug release. Regarding the tabl...et mechanical characteristics, the filler type had the most pronounced effect in formulations with both polymers. Higher tensile strengths were obtained with Avicel PH 102 as the filler in formulations with both HPMC and HPC.

U ovom radu ispitivana je mogućnost primene hipromeloze i hidroksipropilceluloze, kao hidrofilnih polimera velike molekulske mase, za izradu matriks tableta sa produženim oslobađanjem, sa visoko rastvorljivom, visoko doziranom lekovitom supstancom tramadol-hidrohloridom. Udeo hidrofilnog polimera, vrsta nerastvorljivog sredstva za dopunjavanje, udeo tramadol-hidrohlorida, količina lekovite supstance u pojedinačnoj tableti i pritisak kompresije su prepoznati kao kritični parametri formulacije i procesa i u radu je ispitivan njihov uticaj na oslobađanje lekovite supstance i mehaničke karakteristike izrađenih tableta. Zatezna čvrstina tableta je korišćena kao indikator mehaničkih karakteristika tableta. Svi eksperimenti su vršeni korišćenjem simulatora kompakcije, koji omogućava simuliranje profila kompakcije rotacionih tablet mašina velikog kapaciteta. Kod formulacija izrađenih sa obe vrste polimera, udeo tramadol-hidrohlorida se pokazao kao najkritičniji faktor formulacije, pri čemu je ...povećanje udela tramadol-hidrohlorida dovelo do povećanja brzine oslobađanja ove lekovite supstance u početnim fazama oslobađanja lekovite supstance. Vrsta sredstva za dopunjavanje je pokazala najveći uticaj na mehaničke karakteristike izrađenih tableta, kod formulacija izrađenih sa oba tipa hidrofilnih polimera. Više vrednosti zatezne čvrstine tableta su postignute kod formulacija izrađenih korišćenjem Avicel PH 102 kao sredstva za dopunjavanje, bez obzira da li je u sastav tableta kao matriks polimer ulazila hipromeloza ili hidroksipropilceluloza.

Keywords:
tramadol HCl / matrix tablets / hypromellose / hydroxypropylcellulose / drug release / tensile strength / tramadol-hidrohlorid / matriks tablete / hipromeloza / hidroksipropilceluloza / brzina oslobađanja lekovite supstance / zatezna čvrstina
Source:
CICEQ - Chemical Industry and Chemical Engineering Quarterly, 2015, 21, 3, 369-378
Publisher:
  • Savez hemijskih inženjera, Beograd
Projects:
  • Advanced technologies for controlled release from solid drug delivery systems (RS-34007)

DOI: 10.2298/CICEQ140613040N

ISSN: 1451-9372

WoS: 000360690200001

Scopus: 2-s2.0-84940495205
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URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/2352
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