Kollidon sr

Chlorzaxazone (Orchid Chemicals Ltd., Chennai, India), Kollidon^®SR (BASF, Ludwigshafen, Germany), chitosan (practical grade, BASF, Germania), Avicel^®PH (Chemtrec, Falls Church, VA, USA), Aerosil^®200 (Degussa, Frankfurt, Germania), and magnesium stearate (Union Derivan S.A., Barcelona, Spain).
In this study, a CHT with a degree of deacetylation from 51% to 65% has been used because only such kind increases the absorption of active substances hydrophores with high molecular weight [17 ,18 (link)]. It can be considered as a chitin/chitosan copolymer with formulae given in Figure 3.
Other materials used wrre: Avicel^® PH (AV): microcrystalline cellulose. Aerosil^® (A): hydrophilic fumed silica with a specific surface area of 200 m² g⁻¹ and magnesium stearate (ST) was also used. All used compounds accomplish the quality requirements according to the laws of force. These excipients facilitate the application of the direct compression method to obtain optimal hydrophobic substances (CLZ) dispersibility in the powdered mixtures and the association of hydrophilic chitosan.

Kollidon^® SR (BASF SE, Ludwigshafen, Germany) and/or glyceryl behenate (Compritol^® 888 ATO, Gattefossé, Saint-Priest, France) were used as the controlled release agents forming the matrix systems. Prosolv^® SMCC 90 (JRS PHARMA, GmbH & Co. KG, Herzogenaurach, Germany) was used as a dry binder and Kolliwax (BASF SE, Ludwigshafen, Germany) was used as a lubricant. Tramadol hydrochloride (TH) (Sigma Aldrich Chemie GmbH, Darmstadt, Germany) was chosen as a model highly water-soluble drug. The commercial PVA filament (PrimaCreator, Malmö, Sweden) and the filament prepared from HPMC (Affinisol^TM, DuPont, Wilmington, DE, USA) by hot melt extrusion were used for the 3DP coating of the matrix tablets.
Redistilled water and chemicals of analytical grade (HCl, NaCl–Lach-Ner s.r.o., Neratovice, Czech Republic) were used for the preparation of the dissolution media and of the standard solution of tramadol hydrochloride. For the preparation of the alcoholic dissolution medium (40% v/v), ethanol p. a. (Lach-Ner s.r.o., Neratovice, Czech Republic) was used.

The formulation study selected three swellable and expandable polymers (PEO7000K, HPMC 90SH 100K, and HEX250HHX) with Kollidon^®SR (BASF), which was the main substance controlling drug release, and they were prepared via a direct compression method. In addition, microcrystalline cellulose (MCCPH102; Wei Ming) and hydroxypropyl cellulose (HPCssl SFP), which were used as dissolution-enhancing agents, were incorporated in the formulation, where ratios of polymers to Kollidon^® SR of 10:0, 7:3, 5:5, 3:7, and 0:10 were used. All polymeric materials and excipients were firstly passed through a No. 40 mesh and mixed in a plastic bag for 3 min. Nilotinib, which was separately mixed with Aerosil^® 200 and sieved via mesh No. 40, was then added to the above mixture and was further mixed in a plastic bag for another 3 min, and 1% magnesium stearate (Merck, Darmstadt, Germany) was subsequently added as a lubricant with mixing for an appropriate time. Tablets were prepared by weight into a 12-mm-diameter die with the nilotinib content equivalent to 150 mg/tablet and compressed with 0.5 or 1.0 tons of force using a tablet press (Carver Laboratory Press Model C, Carver, Wabash, IN, USA). For the capsule dosage form, powder was manually filled into No. 0 capsules. Finally, the water-swelling ability of the optimized formulations was evaluated, and in vitro dissolution tests were conducted.