Biopharmaceutical evaluation of new slow release tablets obtained by hot tableting of coated pellets with tramadol hydrochloride.

This study was aimed at a biopharmaceutical evaluation of a new oral dosage form of tramadol hydrochloride (TH)--slow release tablets obtained by hot tableting of coated pellets, 100 mg (TP), compared to the conventional slow release tablets, Tramal Retard, 100 mg (TR). Both TP and TR formulations showed a similar release profile of TH (f2 was 71) in in vitro release studies. The in vivo study was a two-treatment, two-period, two-sequence, single-oral dose 100 mg, crossover design using rabbit model with the phases separated by a washout period of 14 days.

In vitro - in vivo evaluation of a new oral dosage form of tramadol hydrochloride--controlled-release capsules filled with coated pellets.

The aim of this study was an in vitro - in vivo evaluation of a new oral dosage form of tramadol hydrochloride (TH), controlled-release capsules filled with coated pellets, 100 mg (TC), compared to the sustained release tablets, Tramal Retard, 100 mg (TR). In vitro release study of both formulations showed a similar release profile of TH over 8 h (f2 was 52). In vivo study (single oral, 100 mg dose administration in 8 rabbits) showed that the amount of TH absorbed into the systemic circulation after TC and TR administration was also similar (90% CI for AUC(0-t) and AUC(0-infinity) were 90-124% and 97-109%, respectively).

Release characteristics of quetiapine fumarate extended release tablets under biorelevant stress test conditions.

The aim of the present work was the investigation of robustness and reliability of drug release from 50 to 400 mg quetiapine extended release HPMC matrix tablets towards mechanical stresses of biorelevant intensity. The tests were performed under standard conditions (USP apparatus II) as well as under simulated gastrointestinal stress conditions. Mechanical stresses including pressure and agitation were applied by using the biorelevant dissolution stress test apparatus as it has been introduced recently.

Hot tabletting of slow-release tramadol hydrochloride microcapsules with cores obtained via compaction.

Background: Coating, as a processing technique, applied to active pharmaceutical ingredient (API) crystals or particles (carriers) with an appropriate polymer allows to obtain a modified-release pharmaceutical dosage form. Such carriers can be the basic ingredient of a multi-unit dosage form. Additionally, coated API crystals (microcapsules) can provide an alternative to spherical granulate (pellets) as the main and most commonly used component of multi-unit dosage forms.

Hot tableting as a new method for obtaining tablets from slow release-coated pellets.

Background: Coating of pellets poses difficulties in the tableting process, which is attributed to the fact that ethylcellulose is a fragile polymer having low resistance to compression. This property of ethylcellulose is the reason why obtaining a slow release profile from tableted pellets comparable with that of uncompressed pellets is practically impossible when traditional tableting process is employed.

Method: This work presents a newly developed method of hot tableting of pellets.