Directly compressed mini-tablets coated in a solid-wall pan for sustained drug release

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1 Directly compressed mini-tablets coated in a solid-wall pan for sustained drug release March 2012 N. Passerini, B. Albertini, L.Rodriguez Department of Pharmaceutical Sciences, University of Bologna C. Funaro, G. Mondelli IMA s.p.a. Solid Dose Division

2 Introduction The production of mini-tablets for sustained drug release is a new and promising area of pharmaceutical research. Sustained-release mini-tablets can be produced either as a matrix or by coating the mini-tablets in a fluid bed apparatus. Thus far, the pan-coating of mini-tablets has not Aim of the study The aim of this study was to investigate the possibility of manufacturing a sustained-release multiple dosage Conclusion The results showed that direct compression yielded mini-tablets with a high amount of TH, a low friability and a high crushing strength. Mini-tablets are a multipleunit dosage form, with the following advantages over single-unit dosage forms: low risk of dose dumping, high degree of dispersion in the GI tract and reproducible bioavailability. been extensively implemented; however, this process produces the following advantages over the fluid bed method: increased production capabilities, reduced waste of coating materials and shorter equipment clean-ing time. form by coating directcompression mini-tablets in a solid wall pan. Theophylline was used as a model drug and WAS an innovative ready-to-use pigment dispersion was tested to evaluate the possibility A solid-wall pan proved a suitable technique for mini-tablet coating and the ready-to-mix piment dispersion proved a suitable method for shortening coating suspension preparation time. Moreover, when manufactured by direct compres- of reducing production time. Thus, a sustained-release multiple-dosage form was sion instead of granulation successfully manufac- or extrusion and spheroniza- tured using a tablet press tion, production is comple- and a solid wall pan. ted in one step, with lower costs and higher production yields. p. 1

3 Experiment part Materials Methods Preparation of mini-tablets TH, Avicel PH 102, spray-dried lactose and magnesium stearate (total 4 kg per batch) were blended using an IMA Cyclops Methods Coating of mini-tablets Each batch of 10 kg mini-tablets was coated in an IMA GS 25 L solid-wall pan. Two different coating formulae were used: a traditional formula containing single components to be dissolved in water before use (A) and the WAS ready-to-use pigment dispersion (B). Theophylline (TH, particle lower than 100 microns) was purchased from BASF, Ludwigshafen, Germany. Avicel PH 102 was kindly supplied by FMC Biopolymer Brussels, Belgium. Spray-dried lactose, magnesium stearate, talc, titanium dioxide, trietilcitrate and Yellow Quinoline (all FU-grade) were purchased blender. Direct compression was performed using IMA Pressima, a tablet press machine for R&D and small batches, equipped with 2 EU-D punches fitting 24 mini-punches, each 2 mm in diameter. The compression force used to obtain 9 mg mini-tablets was 20 kn for all batches, with a 25-rpm fill shoe speed. from Polichimica, in Bologna, Italy, and used as received. Eudragit RL, Eudragit RS (polymer conforming to Ammonio Methacrylate Copolymer, Type A USP/NF 31) and WAS (containing talc, Titanium dioxide, Yellow Quinoline and Trietilcitrate) were kindly supplied by Rofarma Italia, in Milano, Italy. 2 EU-D punch fitting several mini-punches p. 2

4 Methods Coating of mini-tablets Characterization croscopy (SEM ESEM-FEI Quanta 200). The actual drug content and in-vitro drug release profiles Both formulae were tested at different polymer amounts expressed in total solids weight gain percentage. Process parameters for formulae A and B are described in the table. The mini-tablets (mt) were tested for uniformity of mass, friability (using the Roche friabilator) and crushing strength (TBH 200, Erweka, Germany) and the sur- of the coated mini-tablets (CmT) were characterized (USP paddle method, 50 rpm, 900 ml ph 7.4 phosphate buffer at 37 C). The analysis was performed spectro- face characteristics were obser- photometrically (UV2, Unicam) ved using Scanning Electron Mi- at nm Result and discussion containing different amounts of the drug were produced in order to determine the formulation which had mechanical properties suitable for pan- In the first part of the study, four batches of mini-tablets coating, minimal weight variation and maximum drug content. * The mixture of excipients contains: spray-dried lactose 60%, Avicel PH %, magnesium stearate 1%. p. 3

5 All the mts produced had When comparing the opera- As shown in the figure, the un- to the coating level. At the same technological properties suit- tive parameters used in coating, coated mt released 100% of coating level, the dissolution pro- able for coating (high crushing it is evident that the coating the active ingredients in less files of both formulae were not strength and very low friability) conditions for formula A and B than 90 minutes. significantly different, suggesting and complied with the test for were very similar. Sustained release was ensur- that the ready-to-use system is uniformity of mass, according ed by both formulae and all equivalent to the traditional one. to European Pharmacopoeia. This demonstrates the inter- polymer amounts, proportionate Batch mt4 was then selected changeability of the traditional for coating due to its high drug formula containing single com- content. ponents with the ready-to-use pigment dispersion. The second part of the study was aimed at demonstrating The SEM photographs of un- the feasibility of coating mts in coated mt4 and coated mts a solid wall pan and to test the at different levels show that a possibility of replacing the stan- complete, uniform layer was dard coating preparation with a achieved using both formulae, ready-to-use system. even at a low coating level. Dissolution of uncoated and coated mt (formula A and B) at different total solids weight gain. p. 4

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