Studies on Influence of Polymers and Excipients on Crystallization Behavior of Metformin HCl to Improve the Manufacturability

References

• Aakeroy , C. B. , S. Forbes , and J. Desper . 2009 . Using cocrystals to systematically modulate aqueous solubility and melting behavior of an anticancer drug . Journal of the American Chemical Society 131 ( 47 ): 17048 – 17049 .
   PubMed Web of Science ®Google Scholar
• Alpar , O. , J. A. Hersey , and E. Shotton . 1970 . The compression properties of lactose . Journal of Pharmacy and Pharmacology 22 ( Suppl. 1 ): 1S – 7S .
   Google Scholar
• Anderson , N. H. , M. Bauer , N. Boussac , R. Khan-Malek , P. Munden , and M. Sardaro . 1998 . An evaluation of fit factors and dissolution efficiency for the comparison of in vitro dissolution profiles . Journal of Pharmaceutical and Biomedical Analysis 17 ( 4–5 ): 811 – 822 .
   PubMed Web of Science ®Google Scholar
• Aulton , M. E. 2007 . Pharmaceutics: The Design and Manufacture of Medicines, , 2nd ed. London : Churchill Livingstone .
   Google Scholar
• Bandyopadhyay , R. , J. Selbo , G. E. Amidon , and M. Hawley . 2005 . Application of powder x-ray diffraction in studying the compaction behavior of bulk pharmaceutical powders . Journal of Pharmaceutical Sciences 94 ( 11 ): 2520 – 2530 .
   PubMed Web of Science ®Google Scholar
• Banga , S. , G. Chawla , D. Varandani , B. R. Mehta , and A. K. Bansal . 2007 . Modification of the crystal habit of celecoxib for improved processibility . Journal of Pharmacy and Pharmacology 59 ( 1 ): 1 – 11 .
   Web of Science ®Google Scholar
• Barot , B. S. , P. B. Parejiya , T. M. Patel , R. K. Parikh , and M. C. Gohel . 2010 . Development of directly compressible metformin hydrochloride by the spray-drying technique . Acta Pharmaceutica 60 ( 2 ): 165 – 175 .
   PubMed Web of Science ®Google Scholar
• Barot , B. , P. Parejiya , T. Patel , R. Parikh , and M. Gohel . 2012 . Compactibility improvement of metformin hydrochloride by crystallization technique . Advances in Powder Technology 23 ( 6 ): 814 – 823 .
   Web of Science ®Google Scholar
• Brittain , G. 2001 . Particle size distribution, representations of particle shape, size, and distribution . Pharmacy Technology 38 – 45 .
   Google Scholar
• Chavda , V. , and R. K. Maheshwari . 2008 . Tailoring of ketoprofen particle morphology via novel crystallo-co-agglomeration technique to obtain a directly compressible material . Asian Journal of Pharmaceutics 2 ( 1 ): 61 – 67 .
   Google Scholar
• Dahiya , S. 2010 . Studies on formulation development of a poorly water-soluble drug through solid dispersion technique . Thai Journal of Pharmaceutical Sciences 34 : 77 – 87 .
   Google Scholar
• Gao , Y. , H. Zu , and J. J. Zhang . 2010 . [Pharmaceutical cocrystals] . Progress in Chemistry 22 : 829 – 836 [in Chinese]
   Web of Science ®Google Scholar
• Gohel , M. C. , and P. D. Jogani . 1999 . An Investigation of the direct compression characteristics of co processed lactose microcrystalline cellulose using statistical design . Pharmacy Technology 23 : 54 – 62 .
   Google Scholar
• Heckel , R. W. 1961 . An analysis of powder compaction phenomena . Trans. Metall. Soc. AIME. 221 : 671 – 675 .
   Google Scholar
• Hector , N. A. , B. R. Anailien , G. H. Rolando , M. C. E. Dulce , and V. L. Marilo . 2000 . Physico-chemical and solid-state characterization of secnidazole . Il Farmaco 55 ( 11–12 ): 700 – 707 .
   PubMedGoogle Scholar
• Joshi , A. , S. P. Shah , and A. N. Mishra . 2003 . Preparation and evaluation of directly compressible form of rifampicin and ibuprofen . Indian Journal of Pharmaceutical Sciences 65 ( 3 ): 232 – 238 .
   Google Scholar
• Joshi , A. , S. Patel , A. Kaushal , and A. Bansal . 2010 . Compaction studies of alternate solid forms of celecoxib . Advances in Powder Technology 21 ( 4 ): 452 – 460 .
   Web of Science ®Google Scholar
• Kaialy , W. , H. Larhrib , G. P. Martin , and A. Nokhodchi . 2012 . The Effect of engineered mannitol-lactose mixture on dry powder inhaler performance . Pharmaceutical Research 29 ( 8 ): 2139 – 2156 .
   PubMed Web of Science ®Google Scholar
• Kaneto , U. , I. Kengo , W. Zheng , H. Yasuhide , and H. Fumitoshi . 1992 . Inhibitory effect of 2-hydroxypropyl-β-cyclodextrin on crystal-growth of nifedipine during storage: superior dissolution and oral bioavailability compared with polyvinylpyrrolidone K30 . Journal of Pharmacy and Pharmacology 44 ( 2 ): 73 – 78 .
   PubMed Web of Science ®Google Scholar
• Kawashima , Y. , M. Imai , H. Takeuchi , H. Yamamoto , K. Kamiya , and T. Hino . 2003 . Improved flowability and compactibility of spherically agglomerated crystals of ascorbic acid for direct tableting designed by spherical crystallization process . Powder Technology 130 ( 1–3 ): 283 – 289 .
   Web of Science ®Google Scholar
• Kumar , S. , G. Chawla , and A. K. Bansal . 2008 . Role of additives like polymers and surfactants in the crystallization of mebendazole . Yakugaku Zasshi. 128 ( 2 ): 281 – 289 .
   PubMed Web of Science ®Google Scholar
• Lachman , L. , H. A. Libermann , and J. L. Kanig . 1991 . The Theory and Practice of Industrial Pharmacy . Bombay : Varghese Publishing House .
   Google Scholar
• Maghsoodi , M. , D. Hassan-Zadeh , and M. Barzegar-Jalali . 2007 . Improved compaction and packing properties of naproxen agglomerated crystals obtained by spherical crystallization technique . Drug Development and Industrial Pharmacy 33 ( 11 ): 1216 – 1224 .
   PubMed Web of Science ®Google Scholar
• Maghsoodi , M. , O. Taghizadeh , G. P. Martin , and A. Nokhodchi . 2008 . Particle design of naproxen-disintegrant agglomerates for direct compression by a crystallo-co-agglomeration technique . International Journal of Pharmaceutics 351 ( 1–2 ): 45 – 54 .
   PubMed Web of Science ®Google Scholar
• Mallick , S. 2004 . Effect of solvent and polymer additives on crystallization . Indian Journal of Pharmaceutical Sciences 66 ( 2 ): 142 – 147 .
   Google Scholar
• Martin , A. , J. Swarbrick , and A. Cammarata . 1991 . Physical Pharmacy: Physical Chemical Principles in the Pharmaceutical Sciences, , 3rd ed. Bombay : Varghese .
   Google Scholar
• Miranda , L. C. , R. W. David , J. Z. Michael , S. Ning , H. Mazen , and W. S. Lukasz . 2011 . Coformer selection in pharmaceutical cocrystal development: A case study of a meloxicam aspirin cocrystal that exhibits enhanced solubility and pharmacokinetics . Journal of Pharmaceutical Sciences 100 ( 6 ): 2172 – 2181 .
   PubMed Web of Science ®Google Scholar
• Monajjemzadeh , F. , D. Hassanzadeh , H. Valizadeh , M. R. Siahi-Shadbad , J. S. Mojarrad , T. A. Robertson , and M. S. Roberts . 2009 . Compatibility studies of acyclovir and lactose in physical mixtures and commercial tablets . European Journal of Pharmaceutics and Biopharmaceutics 73 ( 3 ): 404 – 413 .
   PubMed Web of Science ®Google Scholar
• Nair , R. H. , J. N. Sarah , J. Adivaraha , and Swarbreek , Eds. 2007 . Co-crystals: Design, properties and formulation mechanism . In Encyclopedia of Pharmaceutical Technology , ed. J. Swarbrick , 621 New York : Informa Healthcare .
   Google Scholar
• Paradkar , A. R. , A. P. Pawar , and N. R. Jadhav . 2010 . Crystallo-co-agglomeration: a novel particle engineering technique . Asian Journal of Pharmaceutics 4 ( 1 ): 4 – 10 .
   Google Scholar
• Parmar , V. K. 2010 . Studies of physicochemical properties of active pharmaceutical ingredient and its modification for improvement of its functionality. Master's thesis, The Gujarat University.
   Google Scholar
• Paroren , P. , and M. Juslin . 1983 . Compressional characteristics of four starches . Journal of Pharmacy and Pharmacology 35 ( 10 ): 627 – 635 .
   PubMed Web of Science ®Google Scholar
• Patel , R. , D. Bhimani , J. Patel , and D. Patel . 2008 . Solid-state characterization and dissolution properties of ezetimibe–cyclodextrins inclusion complexes . Journal of Inclusion Phenomena and Macrocyclic Chemistry 60 ( 3–4 ): 241 – 251 .
   Web of Science ®Google Scholar
• Patil , S. A. , B. S. Kuchekar , A. R. Chabukswar , and S. C. Jagdale . 2010 . Formulation and evaluation of extended-release solid dispersion of Metformin Hydrochloride . Journal of Young Pharmacists 2 ( 2 ): 121 – 129 .
   PubMedGoogle Scholar
• Patra , N. , S. P. Singh , P. Hamd , and M. Vimladevi . 2007 . A systematic study on micromeritic properties and consolidation behavior of the terminaliya arjuna bark powder for processing into tablet dosage form . International Journal of Pharmaceutical Excipients 6 : 6 – 7 .
   Google Scholar
• Raghavan , S. L. , A. Trividic , A. F. Davis , and J. Hadgraft . 2001. Crystallization of hydrocortisone acetate: influence of polymers. International Journal of Pharmaceutics 212(2):213–221.
   PubMed Web of Science ®Google Scholar
• Raval , M. K. , K. R. Sorathiya , N. P. Chauhan , J. M. Patel , R. K. Parikh , and N. R. Sheth . 2013 . Influence of polymers/excipients on development of agglomerated crystals of secnidazole by crystallo-co-agglomeration technique to improve processibility . Drug Development and Industrial Pharmacy 39 ( 3 ): 437 – 46 .
   PubMed Web of Science ®Google Scholar
• Schultheiss , N. , and A. Newman . 2009 . Pharmaceutical cocrystals and their physico-chemical properties . Crystal Growth & Design 9 ( 6 ): 2950 – 2967 .
   PubMed Web of Science ®Google Scholar
• Shah , P. P. , and R. C. Mashru . 2008 . Development and evaluation of artemether taste masked rapid disintegrating tablets with improved dissolution using solid dispersion technique . AAPS PharmSciTech 9 ( 2 ): 494 – 500 .
   PubMed Web of Science ®Google Scholar
• Shan , N. , and M. J. Zaworotko . 2008 . The role of cocrystals in pharmaceutical science . Drug Discovery Today. 13 ( 9–10 ): 440 – 446 .
   PubMed Web of Science ®Google Scholar
• Shivakumar , H. G. , and G. Ramalingaraju . 1999 . Influence of solvents on crystal habit and properties of paracetamol crystals . Indian Journal of Pharmaceutical Sciences 61 ( 2 ): 100 – 104 .
   Google Scholar
• Stepensky , D. , M. Friedman , W. Srour , I. Raz , and A. Hoffman . 2001 . Preclinical evaluation of pharmacokinetic-pharmacodynamic rationale for oral CR metformin formulation . Journal of Controlled Release 71 ( 1 ): 107 – 115 .
   PubMed Web of Science ®Google Scholar
• Subrahmanyam , C. V. S. 2010 . Textbook of Biopharmaceutics and Pharmacokinetics . New Delhi : Vallabh Prakashan .
   Google Scholar
• Tiwari , A. K. 2001 . Modification of crystal habit and its role in dosage form performance . Drug Development and Industrial Pharmacy 27 ( 7 ): 699 – 709 .
   PubMed Web of Science ®Google Scholar
• Vishweshwar , P. , J. A. McMahon , J. A. Bis , and M. J. Zaworotko . 2006 . Pharmaceutical co-crystals . Journal of Pharmaceutical Sciences 95 ( 3 ): 499 – 516 .
   PubMed Web of Science ®Google Scholar
• Yamashita , K. , T. Nakate , K. Okimoto , A. Ohike , Y. Tokunaga , R. Ibuki , K. Higaki , and T. Kimura . 2003 . Establishment of new preparation method for solid dispersion formulation of tacrolimus . International Journal of Pharmacology 267 ( 1–2 ): 79 – 91 .
   PubMed Web of Science ®Google Scholar
• Yuan , G. , Z. Hui , and Z. Jianjun . 2011 . Enhanced dissolution and stability of adefovir dipivoxil by cocrystal formation . Journal of Pharmacy and Pharmacology 63 ( 4 ): 483 – 490 .
   PubMed Web of Science ®Google Scholar
• Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/upst.
   Google Scholar