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, Cetıntas SakaInvestigation of the Stability with Bracketing Design in Tablet Form. Pharm Anal Acta S1: 005. ‚ \b\t\n \t \b \n \t \t \t\n \t \t ˆ ‚ \t\b\n \t ˆ \t \b\t \f ˜ \t\t\n ƒ \t\n™ \f \b ‚ Œ ‚ š\n \t \t \n ‚ \b\n ‚ \b\t\n \t \n \f \t\b\n \t ›\n \t \b \t\t \n\t \t \t\n \t \t ˆ \t \t \t\b \t ˆ \f \n \b ‚ \t \t\b “„ œ žœ Ÿ …\n ¡ ‚ \t ¢ \t Š ‚ ˆ ˜Œ Ž™ ‚ \t \n ‚ \t\t \n \b\t ‚ \b \n ‚ \t\n ˆ \t \b \n\b \t \b \t \f \b £ \t \t \b \t ” \b\t ‚ \f \b \t ˜ \b Š \b™ £ \n \b\t\n \t \t \t \t “¤ ¥¥‹ \n ¦\n\t\b \t \t § ƒ \t\b ¥ ‚ ‚ \t \t‚ ¤\t‚ \b ˜¨‡™ ‚ \t\b ‚ \t \b ‚ \t \b© \t ª‚ ˜Š¨ —™ \t\n \t \t\b \t ¥¥ \b© ‚ \t \nˆ ˜¤ ‘¨ •«™ \b© \t \t\n \t ‚ \n \t ¥ \b© ‚ ¤ ¥ ‚ \t\b ‚ ‰ \t ‚ \t \t \t \b \t ‚ ‚ “¤ ‹‡ ¥¥” \b ‚ \b ‚ \b\b\t ƒ\n \n \f\b \t \t ‰ \t ‚ \t \n \t \b \t \t \b \t \t \b \t \n\t \n\t \f\t\n \t \b \t \t ƒ \n\b \t ‚ ‚ \n ‚ \f\t \t \t \t \n ˜‹ \b™ ‚ \n Œ† \t\n \b\n \t \b \t ¥¥ \t\n \t ‚ ‚ ‚ ‚ \t\b ‚ ‚ \t \n \t \t ‚ \b \n \t ¡ \t \b\t \t ‚ \t \b \t\t \b \b \t Œ \n\b \t ‚ \b \n ‚ \t\b \n \t \t\t ‚\t \t \b ˜ ™ ‰\t\n \t ‚ \t\n \n \t \t ‚ “¤ ¥¥‹ ‚ \b \t •‹ \b ¤ – \t \n «¥° \t\n \t ‹ \b\n \t ‚ \t \b \n ‚ \t ±\t\n © \t ‚ \n \t \b \t \b \t ˜ \b™ ‡ ˜‡ \b™ ¤ ¬ ² \n \t \b \t \t ‡ \n \t \b \n \n \t\n \n \t \t \n \b\t\n \t ™ \b ˜µ™ \b \n ˜µ™ \b ª ˜µ™ \b ª ˜µ ˜µ™ ¤\t \b \t\b \n \t \b \t\b Œ \n \n ‚ \n \t \b\t ‚ ‚ \n \b \n\b \t «€ Œ¶¡¢Œ ˜Œ¶ ¡ ¢Œ ™ ‚ \n \t ‚ \t \t \t \t \b\t ‚ \t \n \t \t \t\b\t \n \t ˆ \t\n \t \t ‚\tª‚ \t ‚\tª‚ \b\n \b\t ¬€ £ \n ‚\t \t £ \t \t ‚ \f \t \t \b \r\t \n ‚ \n \n ’ Ž\t¸ \t \b \t ˜·™ ‚ \t \t \f \t ª\t \t ‚ \b \n \b ’ \t \t \b\t \b \n \t \t \b \n \n \t ‚ \b\t ‚\t ¬ ¥€ ¤ \n \t \n ‚ \t \t ¬€ \t ‚ š ’ ’ \b Table 1: Applied bracketing design. , Cetıntas SakaInvestigation of the Stability with Bracketing Design in Tablet Form. Pharm Anal Acta S1: 005. £ \t ¬ \b \t \t \n \n ¹¢ \t \t \t \t \t \n \b \t ª‚ ˜Š¨ —™—¤ \b\n\b ˜‘ •«™ \r \t \t \b \n \t “ \b \n \t \t ‡ … ‡ \n \n \t \f \b \t ˜ \b ˜ ™ ©\t \b ˜ ‹¯Ž ”¥ ® ‹° \n\b \t ” \b\t ™ \n \t \t … Š \t \t \b \n \t ‡ \t \b \n \t\n \n \b ‚ \t \b \n \b ˆ \t \b \b \n \t \n ‚ \f\n \t\b“ \b \n ‚ \n \t\b \b \n\b \t Š ‚ \t \n \t\n \b\t \t \n \n \n \t \b \f\b “\f\b \n \t Š \b \n \t\b \n \t ‡ \t \t \t \t¸ \t \b \t \b \t ‚ … ” \t ‚ \t \n \t\n \t \b\t \t \t \n \t \t \t \b “\f \b \b \t \t „ —\t ˆ \t ‚ \b \t \n\b \f \b \b \b \b \n \t\n \t \t\n \n …‚\t \t ˜ Š \t \n™ \t \n ‚ \t\n \t\b \b ‚ \t \b \t \t \b \t \t \t \t \n \t \t \b \t\t \t \n ‚ \t\t\n \t \f \b \t\t ‚ \t ˆ \b \t \t\t\n Œ \b \t\t ‚ \b \n \t \t \n \b \t \t \t \b ‰ \t \b \t —Š \t \n ‚ •¥— ‹¥ \t \t \n \n \t \b ’\t ‚ Š•— ”Š \t † ” \b\t \t \t ‹¥— ” \t † ‡ª” \b\t \t \b \t \t ˜… Š™ ¡ \t \b \t‚ \n Š \b \b \t\t \b \n \t Š ‚ ‚\t \b \t \b \t Š \t\t \t\b \t ¤ \n \t … ‡ ‹ ‚ \t ˆ ‚ \t\n \t \b \t \t Table 2: Accelerated stability test results of G1 and G4 of three different batches. Table 3 , Cetıntas SakaInvestigation of the Stability with Bracketing Design in Tablet Form. Pharm Anal Acta S1: 005. Table 4: Long term stability test results of G1 and G4 of three different batches. Average weight (mg) Time1.112Time11.586.111 ± 0.53511.511.5 0 0.5 1 1.5 2 2.5 3 3.5 4 4.50 0.2 0.4 0.6 0.8 1aeasgred (sec)aeasgred (kp)aeasgred (g)aeasgred (%)aeasgred (mg)aeasgred (%):s�mated(%):s�mated(%):s�mated(mg):s�mated(kp):s�mated(sec):s�mated(g) Figure 1: Regression graphs of a) disintegration time, b) average weight, c) hardness, d) friability, e) dissolution rate, and f) content uniformity, measured values , Cetıntas SakaInvestigation of the Stability with Bracketing Design in Tablet Form. Pharm Anal Acta S1: 005. Table 5: Table 6: \t \b \t \n \t \b \t\t \b \n ‚ ‚ \t \t ‡ ‚ \t\n \b \t ‚ \t \t \n \t \t \b \b \t \n \n\t\b \t Š \t \n «‹ \b •¥ \b ‚ ‚ \t\n “¤ ‹‡ \b ‚ \b \f\b\n\b \t \t •‹° \t ‚ \t \n \t \b \n \n\b ˜ Š™ •° ‚ \t\n \t \b \t\t \b ˜ ‡ ‹™ \n ‚ \t \t «‹ \b ‡ Š ‚ •¥ \b ‚ \t \t\t \t \n \t \n \t ‚\t\n \b\t ‘ \t \t\n \b \f ‡‹° ˆ \b\t Š \t \b \t \n ˜ Š™ ‚ ‚ \b \b \t \t \t \t \n \t ‡ \t \n \n \t \t \t \b \t \t\b ˜ ‡ ‹™ \t \n \t \n \t \t \t‚ \t \n ’ \n \t \t ‚ \f \n \t ‡ \t \n ’\t\b \t\n \f\b \t‚ \n \b \t\n ’ \n \t ‚ ° \t \n \b ° “¤ ‹‡ ‰\n \t \t \n \t \n ‚ \t ‚ \f \b \n ” \b\t \b \n\b \t \t \b \n ‚ \t\n ‡” ° ¬¥° ° \f \b \t ° , Cetıntas SakaInvestigation of the Stability with Bracketing Design in Tablet Form. Pharm Anal Acta S1: 005. ˆ \b\t Š \t \b \t \n ˜ Š™ ‚ ‚ \b ¤ \n \t ‡ \t \n \t \t \t \t \f ‚ ‚ \n \t\n \n \f \n \f «¥ ° \t \n \t\n \t † ‹ € ‚ \b † ” \b\t \t \n \t \t \t \t \n ©\t \b \n \t‚ \b \t\t \b ‚ \b \f \t\b \b \n\b \t ‡ ” \b\t ‰\t \n \t «¥ ° \b \t \t Š \t \n † ‹ \b\n ˜ Š™ \t \t ¥‹ Š † \n \b \n\b \t † \t \b \n ‚ \n ¥‹ Š° ¥Š•”‹ ¥Š‡«‹ ˜ ‡ ‹™ £ \t\n \n \t \b\t ‚ \n ‚ \t\n \t \t \t\n \t † \b\t \t \t \t ‚ \f ¥¥° \t Œ \b \t \t \n\t\b “¤ ® ° ‹ – \t \t\b ¥«‹º ‹ \b— ‚ \b \t \t \n \b \f ‚\t \t \n † \n \b \n ‚ \b \n ¥«‡ ¥«¥ ¥•” \b ˜ ™ –\n \t \t \t \n \t ‚ ‚ \b ˜Š™ – \t ‡ŠªŠ” \b— •ª‡ \b— ‹‹ª‡Š‹ \b— \t Š \t \n \n \t \f \b † \t \t £ \t \f\b \n \n \t\n \t\b \t \t\n \t \b \n \t \t\b ‚ \b\t ‚ \t\b \t \f\b \n \t \t\n \t \b \t \t \t \t \t‚ \t ‚ \t\n ‚\t \b \t ‚\t\n \t\n \t\n \t\b ‰ \b ª ‚ \n \n \t\n \t \t\b \b \t\t \t ‚ \t ˆ \b ª \n \t \b \n \t ªŠ \t \n \n \n \b\t \t \n ‰ \t \b ª \t\n \t \n\b \f \t \b \n\t \t \n \b ª \t\n \n \t \t‚ \t \n \b \b \n\b \t \t ˆ \t \n \n „ \t \b\b \t “ \b ‚ \t „ \t\n \b\t ‚ ¦ \t \t ‚ \n§ \t \t \t ’ \n Œ† \t ‚ š ‚ \t\n \t \t ‚ \n \t \t ’ \n \n ¡ ’ \n \n ‡«¥•¬ \t \t \b ¥«””• \t ‚ Š‡Š \t ‡«¥ \t ”¬Š‡ \t \t\n \t ‡««‹¥Š \t \b\t\n \t \n \n \t Œ ‚ \t\n \b \b\t \t \t \t‚ ’\t \t \t\n \t\n \b\t \n \t © \t \t ˜™ \t\n \t‚ ¥¥‹ \t ˜… ”™ ‰ \b \t \t¸ ˜™ \t \b \t \n \t \t \t \t \t \n ‚ \t ¥€ ‰ \b \t \t¸ ‚ \n \t \t \t \t\n \b ‚ \t \n \t \t ‚ \t\n ¥¬«¥Š ¥¬¬¬” \t ‚ ¥¬«‡ \t ¡ \b \n … Š ” ¥Š¥«‹ \t \t\n \t \t … ‹ ” ¥‹¬‡« \t‚ \b\t \t ° Š¥ \t \n \b \t ° ‹¬ \t \n \b \t \t\n \t \n ‚ \b\t \b \t \t‚ ‚ \t \t\n \t ‚ \n \t\n \t \n \t Ž\n\b \t \b \t ’ \t \t \t ‚ \n \t – \t \t \n\t \t \b \t \b\t ’ \n \t\n \t‚ \t ’ ‰\n \t\n \t \t \t\b\n \t \t Š «Š \b \n\b \t\n \t ” \b \n\b \t \t \b …\t \b \n\b \n\b ¥ \n ‚ \n \t ‚\t\n Š¥ \b \n\b \t \t \b \t \t \t ˜‡¥¯Ž ® \b \n ° ”‹ ® ‹ \n\b ™ ™ \n \t ˆ ‚ \t \n ” \b\t \n Š \t \n € \n ‚ \n \n \b \b \n\b ‚\t\n \t\b \t \n \t \t \n \t \b \b \t Œ\b\t \t\n \t \t \b ‚\t \t \t‚ \b\t\n \t \b \n \t ˜ Š™ \n \b ‚ \b \tª \b \t \t ¹ \n \t \t ‚ \b \b\t\n ˜ ‡™ \n ‚ \t \b\t ’\t \t\n \t \f \f \b \n \t \t \b · \n \t \t \t\n ’ \n \n \n \n \t‚ \t \t \n ¹ \t \n \b \t \t \t \b \t \t \t ˆ \b \n \t\b \t \n \t \t \t \n \b \t \n\t Œ \t\n \t‚ \t \t \b \t \t \t \t \t\n \b \t Ž‘ \n \t\n \t\t‚ We are greatful to Dr. Emirhan Nemutlu for kind help and suggestions on Canefe K, Bozkir A (1::1) The Limitations And General De�nitions on the Stability Investigations of Drugs Under Different Climatic Conditions. Acartürk F, Agabeyoglu I, Celebi N, Degim T, Degim Z, et al. (2007) In: Modern Pharmaceutical Technology, Stability and Reaction kinetics, Turk Eczacıları Carstensen JT (1::0) Drug Stability Principles and Practices. Marcel Dekker Pharmaceutica Analytica Acta - Open Access using online manuscript submission, review and tracking systems of Editorial Manager® for quality and quick review processing. 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HG Wang Penn State College of Medicine, USA H Shintani Chuo University Japan Mihaela Baniceru University of Medicine and Pharmacy Romania LEM Quintas Federal University of Rio de Janeiro, Brasil Alexander P Swedish Herbal Institute, Sweden GS Erzinger University of the Region of Joinville Brazil FAI Habeeb Mansoura University Egypt Zhe-Sheng Chen St. John’s University USA MRISoliman Florida A&MUniversity USA Joseph P Fuhr Widener University USA Michael Klepser Ferris State University USA Ajay K Banga Mercer University USA Hideaki Hara Gifu Pharmaceutical University, Japan Don E Farthing Virginia Commonwealth University, USA Jun Zhang Development Sciences of Abbott Laboratories, USA Bonnie A Avery University of Mississippi, USA Srinath palakurthi Texas A&M Health Science Center, USA VF Samanidou Aristotle University of Thessalonik, Europe SC Chauhan The University of South Dakota, South Dakota Anand Iyer Hampton University School of Pharmacy USA B Otieno Abonyo Florida A&M University USA Alan Myers COPHS, Drake University, USA Jacob Runyan Acorda Therapeutics Inc. USA Abdel Halim Daiichi Sankyo Pharma Development, USA Αnastasios E University of Athens Europe Diaconu Camelia C Internal Medicine University, Europe Xudong Yuan Long Island University USA Syed A A Rizvi Nova Southeastern University, USA Hosam Elbaz West Virginia University, USA Elena Garcia F University of Barcelona United Kingdom AR Mohammed Aston University United Kingdom Pasquale Maf�a University of Glasgow United Kingdom PS Hiremath Pharmaceutics International Inc., USA V Vemulapalli Pharmaceutics International Inc. USA Josef Ozer P�zer Biotech, PGRD USA Lee Jia National Cancer Institute/NIH, USA Peisheng Xu University of South Carolina, USA M F Desimone Universidad de Buenos Aires, USA D Douroumis Univeristy of Greenwich, USA Bodhi Chaudhuri University of Connecticut, USA Research Article Bozkir et al-+ \r \f \t \n \t\n \b\t \b\t \t \t \t \b \n \t\n \t\b \b\n \b\t \b \n \t\n \t\b \t\n \t \t \n \n \t \b\t \b\t \n \n \n ‚ \t \t \t‚ \n \t \n \t \b \n \t\n ‚ \b \n ƒ\n \t \t \t\b \t \n \b \n \n\b \b \t \n \t \t \t „ \t \t \n \t \b \n \t\n \n \t \t \t \n \n \b \n \n \n \b \n\b \n \t \b \t \b\t\t\t \n \t\f\t\t \t … ‚ \t \t\b \n\t\b \t\n\b \t \t \t \t \t \t \t \t \b\t \n \r\t \t \b \t \t \b \t \t\b \t \b ‚ \t‚ ‚\t \t\b † ‚ \t\b \t \t ‚ \t \b \t \t\b \b\t\n ‚ \f \t \t \t \t \t \b \n \t\b ‚ \t \t \n ˆ \t \b \n \n\b \t\f \t \t \b\t \n \b \n \n \n \n \t \t \n \t \b \n \t\b \n \t \b\t \t \b \t ‰\n \t \t ˆ \t \t \t \t \t\n \t €\b\t \b \t \b \t \t \t \t \t \t \b \n \b\t \n \t \t \t \t\n \t \t ‚ \t \b \t \b\t\n \t \r \n Œ \t \t \n \t \b \n \t\n Ž‘ ’‰Œ “\rŒ \n Œ \n \n \t ‚ \b \t \t\b \t \t \t \b \t Œ \n \t ‚ \b \t \t \t\b \t \t \b \t \b \f ‚ \t\b\b\t \n \n \t ˆ –\n \t \t \t \b \t\n\b \t \n \n \t \f \b \t \t \b \t Œ\t \t \b \t \f \b \t \t \t \t \t \n\b \t \b \t \t \b \n \t \f \b •€ ‰ \t \t \t „ —\t \n \t ˆ ‚ ˆ \n „ \n \b \t‚ \t ˆ \t\b *Corresponding author: Asuman Bozkir, Ankara University, Faculty of Pharmacy, Department of Pharmaceutical Technology, TR-06100 Ankara-Turkey, Tel: +:0 May 1:, 2013; Bozkir A, Cetıntas HC, Saka OM (2013) Investigation of the Stability with Bracketing Design in Tablet Form. Pharm Anal Acta S1: 005. doi:2435.S1-005© 2013 Bozkir A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and EMA, FDA and ICH guidelines provide guidance to manufacturers of pharmaceutical products for planning and evaluating the stability tests. A full study design is discribed as a model in which samples for every combination of all design factors are tested at all time points. On the other hand matrix and bracket desings are known as a reduced design which can be a suitable alternative to a full design when certain design factors are involved. The bracketing design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested. Reducing number of stability test with bracketing design is considered as an alternative to the full factorial design to In this study, an application of the survey of 4 different forms of glimepiride tablet by bracket design method is given. Among the four doses of the medicine, the extreme amounts of active pharmaceutical ingredient are chosen and several quality parameters such as content uniformity, weight variation, tablet crushing strength, disintegration and friability, tablet dissolution rate, disintegration time, active substance ingredient amount, diameter and thickness of tablets are determined in accelerated and long-term stability conditions. Using these results, the properties of tablets with intermediate amounts are calculated with the help of statistical modeling. For four of six examined quality control parameters the r² values are close to 1 and all found F values are greater than the tabulated values. These Ankara University, Faculty of Pharmacy, Department of Pharmaceutical Technology, TR-06100 Ankara-Turkey Bozkir A, Cetıntas HC, Saka OM (2013) Investigation of the Stability with Bracketing Design in Tablet Form. Pharm Anal Acta S1: 005. 10.4172/2153-2435.S1-005 K, Bozkir A (1::0) An Investigation of Stabilities on Tablets and Harmonised Tripartite Guideline Q1 A (R2) (2003) Stability Testing of New Harmonised Tripartite Guideline Q1 D (2003) Bracketing and Matrixing Y (2004) Semiparametric inferencens in stability design. University of E, Kir S, Ozyuncu O, Beksac MS (2007) Simultaneus separation and determination of seven quinolones Using HPLC: Analysis of Levo�oxacin and 11. A, Möller H, Wirbitzki E (1::8) Biopharmaceutical characterization of oral immediate release drug products. In vitro/in vivo comparison of phenoxymethylpenicillin potassium, glimepiride and levo�oxacin. Eur J Pharm TY, Chen CW (2003) Overview of stability study designs. J Biopharm Stat Bozkir A, Cetıntas HC, Saka OM (2013) Investigation of the Stability with Bracketing Design in Tablet Form. Pharm Anal Acta S1: 005. 10.4172/2153-2435.S1-005 Canefe K, Bozkir A (1::0) An Investigation of Stabilities on Tablets and ICH Harmonised Tripartite Guideline Q1 A (R2) (2003) Stability Testing of New ICH Harmonised Tripartite Guideline Q1 D (2003) Bracketing and Matrixing Min Y (2004) Semiparametric inferencens in stability design. University of Nemutlu E, Kir S, Ozyuncu O, Beksac MS (2007) Simultaneus separation and determination of seven quinolones Using HPLC: Analysis of Levo�oxacin and 11. Frick A, Möller H, Wirbitzki E (1::8) Biopharmaceutical characterization of oral immediate release drug products. In vitro/in vivo comparison of phenoxymethylpenicillin potassium, glimepiride and levo�oxacin. Eur J Pharm Lin TY, Chen CW (2003) Overview of stability study designs. J Biopharm Stat