Pharmaceutical Composition Comprising Glucopyranosyl Diphenylmethane Derivatives, Pharmaceutical Dosage Form Thereof, Process For Their Preparation And Uses Thereof For Improved Glycemic Control In A Patient - EP2395968

The patent EP2395968 was granted to Boehringer Ingelheim on Jan 17, 2024. The application was originally filed on Feb 11, 2010 under application number EP10703652A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP2395968

BOEHRINGER INGELHEIM
Application Number
EP10703652A
Filing Date
Feb 11, 2010
Status
Granted And Under Opposition
Dec 15, 2023
Grant Date
Jan 17, 2024
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (19)

Patent oppositions filed by competitors challenge the validity of a granted patent. These oppositions are typically based on claims of prior art, lack of novelty, or non-obviousness. They are a key part of the process for determining a patent's strength and enforceability.

CompanyOpposition DateRepresentativeOpposition Status

Get instant alerts for new oppositions and patent status changes

BRAND MURRAY FULLEROct 17, 2024BRAND MURRAY FULLERADMISSIBLE
BRAND MURRAY FULLER SERVICESOct 17, 2024BRAND MURRAY FULLERADMISSIBLE
GENERICS UKOct 17, 2024TER MEER STEINMEISTER & PARTNERADMISSIBLE
HGFOct 17, 2024HGFADMISSIBLE
LUIGIOct 17, 2024TER MEER STEINMEISTER & PARTNERADMISSIBLE
MAIWALDOct 17, 2024MAIWALDADMISSIBLE
STADA ARZNEIMITTELOct 17, 2024KERNEBECKADMISSIBLE
ZBM PATENTSOct 17, 2024ZBM PATENTS ZEAADMISSIBLE
AERAOct 16, 2024AERAADMISSIBLE
AERAOct 16, 2024BARDEHLE PAGENBERG SLADMISSIBLE
GALENICUM HEALTH SLUOct 16, 2024GALENICUM HEALTH SLUADMISSIBLE
HAMM & WITTKOPPOct 16, 2024HAMM & WITTKOPPADMISSIBLE
KRAUS & LEDERER PARTGMBBOct 16, 2024KRAUS & LEDERER PARTGMBBADMISSIBLE
TEVA PHARMACEUTICALSOct 16, 2024VON KAUFFMANNADMISSIBLE
BULLE DROct 15, 2024KUTZENBERGER WOLFF & PARTNERADMISSIBLE
CAMULONOct 14, 2024REDDIE & GROSEADMISSIBLE
ZENTIVA KSOct 14, 2024REDDIE & GROSEADMISSIBLE
POLPHARMAOct 10, 2024ELKINGTON AND FIFEADMISSIBLE
SANDOZOct 10, 2024ELKINGTON AND FIFEADMISSIBLE

Patent Citations (48) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
DESCRIPTIONWO0127128
DESCRIPTIONWO03099836
DESCRIPTIONWO2005092877
DESCRIPTIONWO2006034489
DESCRIPTIONWO2006064033
DESCRIPTIONWO2006117359
DESCRIPTIONWO2006117360
DESCRIPTIONWO2006120208
DESCRIPTIONWO2007025943
DESCRIPTIONWO2007028814
DESCRIPTIONWO2007031548
DESCRIPTIONWO2007093610
DESCRIPTIONWO2007128749
DESCRIPTIONWO2008020011
DESCRIPTIONWO2008049923
DESCRIPTIONWO2008055870
DESCRIPTIONWO2008055940
EXAMINATIONEP2187879
EXAMINATIONUS2005209166
EXAMINATIONUS2007249544
EXAMINATIONUS2008234367
EXAMINATIONWO2005092877
EXAMINATIONWO2009022007
INTERNATIONAL-SEARCH-REPORTWO2007128749
INTERNATIONAL-SEARCH-REPORTWO2008116179
OPPOSITIONCA2557801
OPPOSITIONEP2187879
OPPOSITIONUS2005209166
OPPOSITIONUS2007249544
OPPOSITIONUS2008234367
OPPOSITIONUS2009023913
OPPOSITIONWO0151463
OPPOSITIONWO2005092877
OPPOSITIONWO2006117359
OPPOSITIONWO2007128749
OPPOSITIONWO2008055940
OPPOSITIONWO2008090210
OPPOSITIONWO2008116179
OPPOSITIONWO2008116195
OPPOSITIONWO2009022007
OPPOSITIONWO2010092124
OPPOSITIONWO2010092126
OTHEREP2187879
OTHERUS2005209166
OTHERUS2007249544
OTHERUS2008234367
OTHERWO2005092877
OTHERWO2009022007

Non-Patent Literature (NPL) Citations (86) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
EXAMINATION- Sturtevant Inc., "Micronizer Jet Mill", Hanover/MA, (2000), pages 1 - 6, URL: https://www.sturtevantinc.com/assets/Sturtevant_Micronizer_Brochure.pdf, (20180830), XP093233604-
OPPOSITION- Allen Jr L V, Luner, P E, "Magnesium Stearate", Allen Jr L V, Luner, P E, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090203), pages 404 - 407, ISBN 978-0-85369-792-3, XP055956908-
OPPOSITION- Anonymous, "2.5 Dissolution and Granule Properties", Handbook of Pharmaceutical Granulation Technology, Taylor & Francis , (20050101), pages 539 - 542, ISBN 978-0-8247-2647-8, XP093232995-
OPPOSITION- Anonymous, "Assessment report Jardiance: International non-proprietary name: empagliflozin; Procedure No. EMEA/H/C/002677/0000", Assessment Report EMA/CHMP/137741/2014, European Medicines Agency, (20140320), pages 1 - 99, XP093166086-
OPPOSITION- Anonymous, "Dapagliflozin: Uses, Interactions, Mechanism of Action", DrugBank Online, (20241216), URL: https://go.drugbank.com/drugs/DB06292?__ hstc=753710.f3a60e781a0ed 4062c0d4f3b39b45012.1709034426969.1709 034426969.1709034426969. 1&__hssc=753710.1.1709034426969&__hsfp =4011434659&_ga=2.151684 33.645857728.1709034426 - 1846527267.1709034426, XP093234473-
OPPOSITION- Anonymous, "Magnesii Stearas // Magnesium Stearate", Anonymous, 92-4-156301-X, The International Pharmacopoeia, 4th edition, World Health Organization , (20060101), vol. 1, pages 569 - 571, ISBN 978-92-4-156301-7, XP093233909-
OPPOSITION- Anonymous, "Micronizer Jet Mill (SV006)", Micronizer Jet Mill, Sturtevant Inc., US, US, pages 1 - 6, Micronizer Jet Mill, URL: https://sturtevantinc.com/wp-content/uploads/2020/07/Sturtevant_Micronizer_Brochure.pdf, XP093233604-
OPPOSITION- Anonymous, "Mie Theory, the first 100 years", Malvern, pages 1 - 10, Malvern, URL: https://www.atascientific.com.au/wp-content/uploads/2017/02/Mie-Theory-the-first-hundred-years-MRK1304-02.pdf, (20230227), XP093027128-
OPPOSITION- Anonymous, "PRODUCT MONOGRAPH Pr JARDIANCE (TM) empagliflozin tablets 10 mg and 25 mg", PRODUCT MONOGRAPH, Boehringer Ingelheim (Canada) Ltd, pages 1 - 49, PRODUCT MONOGRAPH, URL: http://www.boehringeringelheim.ca, XP093234114-
OPPOSITION- Anonymous, "Section 2.9.31 - Particle Size Analysis by Laser Light Diffraction", EUROPEAN PHARMACOPOEIA 6.0, The Stationery Office/Tso, (20070723), pages 311 - 314, ISBN 9287160546, XP055638472-
OPPOSITION- Anonymous, "ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS Forxiga 5 mg Filmtabletten", ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS, European Medicines Agency, pages 1 - 95, ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS, URL: http://www.ema.europa.eu/, XP093234545-
OPPOSITION- Anonymous, "ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS Invokana 100 mg Filmtabletten Invokana 300 mg Filmtabletten", ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS, European Medicines Agency, pages 1 - 54, ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS, URL: https://ec.europa.eu/health/documents/community-register/2021/20210111150172/anx_150172_de.pdf, XP093234549-
OPPOSITION- Armstrong Norman Anthony, "Tablet Manufacture", Armstrong Norman Anthony, J. Swarbrick, Encyclopedia of Pharmaceutical Technology Third edition Volume 1, Informa Healthcare USA, Inc, (20070101), pages 3653 - 3672, XP093138871-
OPPOSITION- Augsburger Larry L, Mark J. Zellhofer, "Tablet Formulation", Augsburger Larry L, Mark J. Zellhofer, J. Swarbrick, Encyclopedia of Pharmaceutical Technology Third edition Volume 1 , Informa Healthcare USA, Inc, (20070101), pages 3641 - 3652, XP093138864-
OPPOSITION- Aulton Michael E., "Crystal morphology", Aulton Michael E., AULTON M.E. (ED.).2, PHARMACEUTICS. THE SCIENCE OF DOSAGE FORM DESIGN ED. 2, UK, CHURCHILL LIVIGSTONE , (20020101), pages 133 - 133, 027702, ISBN 978-0-443-05517-1, XP093233672-
OPPOSITION- Aulton Michael E., "Formulation additives: flow activators", Aulton Michael E., AULTON M.E. (ED.).2, PHARMACEUTICS. THE SCIENCE OF DOSAGE FORM DESIGN ED. 2, UK, CHURCHILL LIVIGSTONE , (20020101), pages 209 - 209, 027702, ISBN 978-0-443-05517-1, XP093233668-
OPPOSITION- Bauer K H; Et Al, "Granuliertechniken und Granulatherstellung", Bauer K H; Et Al, Bauer K.H., Frömming K.-H., Führer C. (Editors), Pharmazeutische Technologie ; 94 Tabellen, STUTTGART , GEORG THIEME VERLAG STUTTGART , (19930101), page 3pp, 293, ISBN 978-3-13-692504-1, XP055410714-
OPPOSITION- "Chapter 4: Factors influencing drug absorbtion and drug availability", Modern pharmaceutics; 4. ed., rev. and expanded, USA, Marcel Dekker, (20020101), pages 93 - 116, ISBN 0-8247-0674-9, XP009558788-
OPPOSITION- "Chapter 7: Preformulation", Modern pharmaceutics; 4. ed., rev. and expanded, USA, Marcel Dekker, (20020101), pages 167 - 185, ISBN 0-8247-0674-9, XP009558789-
OPPOSITION- D47 - Boards of Appeal of The European Patent Office, T1476/15, 2021-
OPPOSITION- D55 - Reply OA by the patentee 10.09.2021-
OPPOSITION- D56 - Third party observations filed 14.11.2019 together with Experimental data submitted by TPO4 during prosecution of the patent-
OPPOSITION- David Attwood, Alexander T Florence, "Solids", David Attwood, Alexander T Florence, David Attwood; Alexander T. Florence, PHYSICAL PHARMACY, Pharmaceutical Press , (20080101), page 2pp, 7, ISBN 978-0-85369-725-1, XP055754273-
OPPOSITION- Deodatt A Wadke, Abu T M Serajuddin, Harold Jacobson, "CHAPTER 1: Preformulation Testing", Deodatt A Wadke, Abu T M Serajuddin, Harold Jacobson, H.A. Liebermann et al.,, Pharmaceutical Dosage Forms Tablets Volume 1, US , Marcel Dekker , (19890101), vol. 1, pages 1 - 73, ISBN 978-0-8247-8044-9, XP009184711-
OPPOSITION- Edge S., Ah Kibbe, J Shur, "Lactose, Monohydrate", Edge S., Ah Kibbe, J Shur, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090310), pages 364 - 369, ISBN 978-0-85369-792-3, XP093228149-
OPPOSITION- Emea, "ICH Topic Q 6 A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Step 5 NOTE FOR GUIDANCE SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAE SUBSTANCES", European Medicines Agency CPMP/ICH/3 67/96, European Medicines Agency CPMP/ICH/3 67/96 , (20240404), XP093147842-
OPPOSITION- Fred J. Bandelin, "Chapter 3 - Compressed Tablets by Wet Granulation", Fred J. Bandelin, Bandelin et al., Pharmaceutical Dosage Forms Tablets Volume 1, US , Marcel Dekker , (19890101), vol. 1, pages 131 - 193, ISBN 978-0-8247-8044-9, XP055370821-
OPPOSITION- Gibaldi Milo, "Gastrointestinal Absorption-—Physicochemical Considerations ", Gibaldi Milo, M. Gibaldi, Biopharmaceutics and Clinical Pharmacokinetics, FOURTH EDITION, Lea & Febinger, (19910101), page 51, ISBN 0-8121-1346-2, XP093186860-
OPPOSITION- Gilbert S. Banker Et Al, "Chapter 10 - Tablet Dosage Forms", Modern pharmaceutics; 4. ed., rev. and expanded, USA, Marcel Dekker, (20020101), pages 287 - 305, ISBN 0-8247-0674-9, XP055369684-
OPPOSITION- Guest R T, "Croscarmellose Sodium", Guest R T, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090206), pages 206 - 208, ISBN 978-0-85369-792-3, XP093234018-
OPPOSITION- Heinz Sucker Et Al., "3.4.2 Feste Arzneiformen", Heinz Sucker Et Al., H. Sucker et al., Pharmazeutische Technologie, 2. Auflage, Georg Thieme Verlag , (19910101), pages 158 - 161, ISBN 978-3-13-395802-8, XP055308164-
OPPOSITION- He Xiaorong, "18.2.8 Particle Size, Particle Morphology, and Surface Area", He Xiaorong, Y. QIU ET AL., Developing Solid Oral Dosage Forms Pharmaceutical Theory and Practice, Elsevier Science, (20090101), pages 414 - 415, ISBN 0-444-53242-0, XP093046937-
OPPOSITION- Hubert Mario, Beth Sarsfield, Boris Shekunov, John Grosso, "Oral solid dosage form: From choice of particle size technique to method development and validation", AMERICAN PHARMACEUTICAL REVIEW, Russell Publishing, US, US , (20080701), vol. 11, no. 5, ISSN 1099-8012, pages 14 - 23, XP093234575-
OPPOSITION- James Swarbrick Et Al, "Milling of Active Pharmaceutical Ingredients", James Swarbrick Et Al, SWARBRICK J., ENCYCLOPEDIA OF PHARMACEUTICAL TECHNOLOGY.Third Edition, NEW YORK, US , INFORMA HEALTHCARE. , (20070101), pages 2339 - 2351, 032782, ISBN 978-0-8493-9394-5, XP055301363-
OPPOSITION- James Swarbrick Et Al., "Tablet Formulation", James Swarbrick Et Al., J. Swarbrick et al., Encyclopedia of Pharmaceutical Technology, 2nd edition, (20020101), vol. 3, pages 2701 - 2712, ISBN 978-0-8247-2824-3, XP055308380-
OPPOSITION- Joseph P. Remington, "Dissolution", Joseph P. Remington, Gennaro Alfonso R., Remington: the science and practice of pharmacy, Easton, Pennsylvania , Mack Publishing Company , (19950101), vol. 1, page 2pp, 595, ISBN 978-0-912734-04-0, XP055282825-
OPPOSITION- Kassel Jorie, "Using Image Analysis to Differentiate Particle Size and Shape in Drug Products with Multiple Components", In the Lab eNewsletter, (20231206), vol. 18, no. 12, pages 1 - 8, XP093234471-
OPPOSITION- Kurt H. Bauer, Et Al, "Passages; Chapter 7.4 Bioverfügbarkeit und Bioäquivalenz // Chapter 16.5 Verlängerung der Wirkungsdauer von Wirkstoffen", Kurt H. Bauer, Et Al, K.H. Bauer et al., Pharmazeutische Technologie, 5. Auflage, (19970101), pages 209 - 210, 365, ISBN 978-3-437-25630-1, XP055641330-
OPPOSITION- Leon Lachman, Herbert A Lieberman and Joseph L Kanig, "Factors Affecting Drug Absorption", Leon Lachman, Herbert A Lieberman and Joseph L Kanig, L. Lachmann et al., THEORY AND PRACTICE OF INDUSTRIAL PHARMACY third edition, Philadelpia , Lea & Febiger , (19860101), pages 221 - 222, XP003032295-
OPPOSITION- LIEBERMAN H A, LACHMAN L, "Preformation Testing", LIEBERMAN H A, LACHMAN L, Wadke et al, Pharmaceutical Dosage Forms, MARCEL DEKKER INC. , (19800101), vol. 1, pages 1 - 4, ISBN 978-0-8247-6918-5, XP003021160-
OPPOSITION- MA Kabir, JP Reo, "Hydroxypropyl Cellulose", MA Kabir, JP Reo, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090223), pages 317 - 322, ISBN 978-0-85369-792-3, XP093163295-
OPPOSITION- M. E. Aulton, "Chapter 13: MIxing", M. E. Aulton, M.E. Aulton, PHARMACEUTICS: THE SCIENCE OF DOSAGE FORM DESIGN, Second Edition, Elsevier , (20020101), pages 181 - 196, ISBN 0-443-05517-3, XP055514650-
OPPOSITION- M. E. Aulton, M. Ashford, "Bioavailability - physicochemical and dosage form factors // Tablet Manufacturing", M. E. Aulton, M. Ashford, Aulton, Aulton's Pharmaceutics, The Design and Manufacture of Medicines, 3rd edition, CHURCHILL LIVINGSTONE ELSEVIER, (20070101), pages 286 - 449, ISBN 978-0-443-10107-6, XP055308287-
OPPOSITION- M.E. Aulton, "Passage; Chapter 25: Methods of granulation Granulation", M.E. Aulton, AULTON, PHARMACEUTICS: THE SCIENCE OF DOSAGE FORM DESIGN, Second Edition, UK, Elsevier , (20020101), pages 2pp, 366 - 367, ISBN 0-443-05517-3, XP055395898-
OPPOSITION- M E Aulton, "Tablet production via granulation", M E Aulton, AULTON, PHARMACEUTICS: THE SCIENCE OF DOSAGE FORM DESIGN, Second Edition, UK, Elsevier , (20020101), pages 403 - 404, ISBN 0-443-05517-3, XP055626318-
OPPOSITION- Michael E. Aulton, Et Al., "Chapter 17: Bioavailability - physicochemical and dosage form factors", Michael E. Aulton, Et Al., M.E. Aulton, PHARMACEUTICS: THE SCIENCE OF DOSAGE FORM DESIGN, Second Edition, Elsevier , (20020101), pages 234 - 252, ISBN 0-443-05517-3, XP055466214-
OPPOSITION- Michael E Aulton, "The design of dosage forms", Michael E Aulton, AULTON M.E. (ED.).2, PHARMACEUTICS. THE SCIENCE OF DOSAGE FORM DESIGN ED. 2, UK, CHURCHILL LIVIGSTONE , (20020101), pages 6 - 7, 027702, ISBN 978-0-443-05517-1, XP055565127-
OPPOSITION- Mujumdar Arun S., Et.Al., "2. Classification of Pharmaceutical Products with respect to Dryer Selection", Mujumdar Arun S., Et.Al., A.S. Mujumdar, Handbook of industrial drying, Vol. 2, US, Dekker, (19950101), vol. 2, pages 744 - 746, ISBN 978-0-8247-9644-0, XP093233876-
OPPOSITION- Peter Davies, "Passage; Chapter 11: Tablets", Peter Davies, Mark Gibson, Pharmaceutical Preformulation and Formulation 2004 (Mark Gibson) with subtitle A Practical Guide from Candidate Drug Selection to Commercial Dosage Form, US , Denver, Colo : Interpharm Press, c2002 , (20010101), pages 403 - 440, ISBN 1-57491-120-1, XP009558774-
OPPOSITION- Podczeck Fridrun, "Chapter 5: Powder, granule and pellet to fill two-piece hard capsules", Podczeck Fridrun, Podczeck Fridrun ; Jones Brian E., Pharmaceutical Capsules, GB , Pharmaceutical Press , (20040201), pages 101 - 118, ISBN 978-0-85369-568-4, XP093233889-
OPPOSITION- Prakashan N., Et Al, "Problems in tablet manufacture (processing problems)", A Text Book of Pharmaceutics - I for First Year Diploma in Pharmacy, 15th ed.., India, (20080601), pages 14.33 - 14.36, ISBN 978-81-85-79014-5, XP093234003-
OPPOSITION- Raymond C Rowe, Et Al., "Cellulose, microcrystalline", Raymond C Rowe, Et Al., R.C. Rowe, P.J. Sheskey and S.C. Owen, Handbook of Pharmaceutical Excipients, Fifth Edition, US , Pharmaceutical Press and American Pharmacists Association , (20060101), pages 132 - 135, ISBN 1-58212-058-7, XP055466201-
OPPOSITION- Raymond C Rowe, Paul J Sheskey ,Sian C Owen, "Croscarmellose sodium", Raymond C Rowe, Paul J Sheskey ,Sian C Owen, R.C. Rowe, P.J. Sheskey and S.C. Owen, Handbook of Pharmaceutical Excipients, Fifth Edition, US , Pharmaceutical Press and American Pharmacists Association , (20060101), pages ,211 - 704, ISBN 1-58212-058-7, XP055784136-
OPPOSITION- Ritschel, W. A.; Bauer-Brandl, Annette, "2.1 Wirkstoffe - Beurteilung fur Praformulierung", Ritschel, W. A.; Bauer-Brandl, Annette, Wolfgang A. Ritschel ; Annette Bauer-Brandl, Die Tablette : Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Aulendorf, DE, ECV - Editio-Cantor-Verl., (20020101), pages 60 - 63, ISBN 3-87193-228-0, XP009558744-
OPPOSITION- Ritschel, W. A.; Bauer-Brandl, Annette, "2.3.1 Füllmittel", Ritschel, W. A.; Bauer-Brandl, Annette, Wolfgang A. Ritschel ; Annette Bauer-Brandl, Die Tablette : Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Aulendorf, DE, ECV - Editio-Cantor-Verl., (20020101), pages 69 - 78, ISBN 3-87193-228-0, XP009558743-
OPPOSITION- Ritschel, W. A.; Bauer-Brandl, Annette, "3.2 Mahlen (Zerkleinern, Brechen)", Ritschel, W. A.; Bauer-Brandl, Annette, Wolfgang A. Ritschel ; Annette Bauer-Brandl, Die Tablette : Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Aulendorf, DE, ECV - Editio-Cantor-Verl., (20020101), pages 207 - 208, ISBN 3-87193-228-0, XP009558742-
OPPOSITION- Ritschel, W. A.; Bauer-Brandl, Annette, "4.4 Feuchte Granulation", Ritschel, W. A.; Bauer-Brandl, Annette, Wolfgang A. Ritschel ; Annette Bauer-Brandl, Die Tablette : Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Aulendorf, DE, ECV - Editio-Cantor-Verl., (20020101), pages 268 - 270, ISBN 3-87193-228-0, XP009558741-
OPPOSITION- Ritschel, Wolfgang A, "Kapitel 2: Tablettenbestandteile: 2.2 Auswahl der Hilfsstoffe und ihre Einarbeitung", Ritschel, Wolfgang A, Wolfgang A. Ritschel ; Annette Bauer-Brandl, Die Tablette : Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Aulendorf, DE, ECV - Editio-Cantor-Verl., (20020101), pages 63 - 67, ISBN 3-87193-228-0, XP009556297-
OPPOSITION- RJ Harwood, "Hydroxypropyl Cellulose", RJ Harwood, Kibbe Arthur H., Handbook of Pharmaceutical Excipients, Washington, D.C. , American Pharmaceutical Association , (20000101), pages 244 - 248, ISBN 978-0-917330-96-4, XP002540628-
OPPOSITION- RJ HARWOOD, "HYDROXYPROPYL CELLULOSE", RJ HARWOOD, Royal Pharmaceutical Society of Great Britain, Handbook of Pharmaceutical Excipients, UK/USA , Pharmaceutical Press; The American Pharmacists Association , (20060101), pages 336 - 340, ISBN 0-85369-618-7, XP002765577-
OPPOSITION- Rowe Raymond C, Et Al, "Cellulose, Microcrystalline", Rowe Raymond C, Et Al, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090101), pages 129 - 133, ISBN 978-0-85369-792-3, XP055796468-
OPPOSITION- Rudnic Edward M, Joseph D Schwartz, "Oral Solid Dosage Forms", Rudnic Edward M, Joseph D Schwartz, Gennaro, A.R.; Der Marderosian, A.H.; Hanson, G.R.; Medwick, T.; Popovich, N.G.; Schnaare, R.L.; Schwartz, J.B.; White, H.S., Remington: The Science and Practice of Pharmacy 20th Edition, Lippincott Williams , (20000101), pages 858 - 893, ISBN 0-683-30647-2, XP093109037-
OPPOSITION- Staniforth John, "Powder flow", Staniforth John, AULTON M.E. (ED.).2, PHARMACEUTICS. THE SCIENCE OF DOSAGE FORM DESIGN ED. 2, UK, CHURCHILL LIVIGSTONE , (20020101), pages 197 - 210, 027702, ISBN 978-0-443-05517-1, XP093233615-
OPPOSITION- "Tablet Manufacture", J Swarbrick, J. C. Boylan, ENCYCLOPEDIA OF PHARMACEUTICAL TECHNOLOGY, US, Marcel Dekker, (20020101), vol. 3, pages 2713 - 2732, ISBN 0-8247-2824-6, XP009558787-
OPPOSITION- United States Pharmacopeia Convention, Inc., "General Information/ (1151) Pharmaceutical Dosage Forms", The United States Pharmacopeia, (20050101), vol. USP 28-NF 23, page 3pp, 2711, ISBN 978-1-889788-25-8, XP055410725-
OPPOSITION- U. V. Banakar, "Passage; Chapter 5: Factors That Influence Dissolution Testing", U. V. Banakar, U.V. Banakar, Pharmaceutical Dissolution Testing, US , Marcel Dekker Inc. , (19920101), pages 136 - 145, ISBN 0-8247-8567-3, XP055641322-
OPPOSITION- W.A. Ritschel, A. Bauer-Brandl, "Direkttablettierbare Mischungen", Die Tablette Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Edito Cantor Verlag , (20020101), vol. 7, pages 252 - 260, ISBN 978-3-87193-228-1, XP008180046-
OPPOSITION- Wells James, Aulton M. E., "8. Pharmaceutical preformulation: the physicochemical properties of drug substance", Wells James, Aulton M. E., AULTON M.E. (ED.).2, PHARMACEUTICS. THE SCIENCE OF DOSAGE FORM DESIGN ED. 2, CHURCHILL LIVIGSTONE , (20020101), pages 113 - 138, 027702, ISBN 978-0-443-05517-1, XP093196068-
OPPOSITION- Zhigang Sun, Naiqi Ya, Richard C. Adams, Florence S. Fang, "Particle Size Specifications for Solid Oral Dosage Forms: A Regulatory Perspective", AMERICAN PHARMACEUTICAL REVIEW, Russell Publishing, US, US , (20100501), vol. 13, no. 4, ISSN 1099-8012, pages 1 - 6, XP093234568-
OPPOSITION- Picker-Freyer Katharina M., "6.4 TABLET PRODUCTION SYSTEMS", Picker-Freyer Katharina M., Shayne Cox Gad (Editor), Pharmaceutical manufacturing handbook: production and processes, Hoboken, New Jersey , John Wiley & Sons, Inc , (20080317), pages 1053 - 1098, doi:10.1002/9780470259818.ch26, ISBN 978-0-470-25958-0, XP093233905
OPPOSITION- GAVIN ANDREWS, DAVID JONES, HUI ZHAI, OSAMA ABU DIAK, GAVIN WALKER, "EFFECTS OF GRINDING IN PHARMACEUTICAL TABLET PRODUCTION", GAVIN ANDREWS, DAVID JONES, HUI ZHAI, OSAMA ABU DIAK, GAVIN WALKER, Shayne Cox Gad (Editor), Pharmaceutical manufacturing handbook: production and processes, Hoboken, New Jersey , John Wiley & Sons, Inc , (20080101), pages 1165 - 1190, doi:10.1002/9780470259818.ch29, ISBN 978-0-470-25958-0, XP002685117
OPPOSITION- Peter Timmins; Punit H. Marathe; Gill Cave; Mark E. Arnold; Andrew B. Dennis; Douglas S. Greene, "Development of a glyburide‐metformin fixed combination tablet with optimized glyburide particle size", DRUG DEVELOPMENT RESEARCH., NEW YORK, NY, US, US , (20060124), vol. 66, no. 1, doi:10.1002/ddr.20035, ISSN 0272-4391, pages 25 - 35, XP071571943
OPPOSITION- Brian R. Rohrs, Amidon Gregory E., Meury Richard H., Secreast Pamela J., King Harry M., Skoug Connie J., "Particle size limits to meet USP content uniformity criteria for tablets and capsules", Journal of Pharmaceutical Sciences, American Chemical Society and American Pharmaceutical Association, (20060501), vol. 95, no. 5, doi:10.1002/jps.20587, ISSN 00223549, pages 1049 - 1059, XP055077685
OPPOSITION- Snorek Sharon M., Bauer John F., Chidambaram Nallaperumal, Doub William H., Duffy Eric P., Etzler Frank M., Kelly Richard N., Lane Justin J., Mueller Ronald L., Prasanna Hullahalli R., Pujara Chetan P., Reif Van D., Scarlett Brian, Stowell Joseph G., Toma Pascal H., "PQRI Recommendations on Particle-Size Analysis of Drug Substances Used in Oral Dosage forms", Journal of Pharmaceutical Sciences, Wiley, (20070601), vol. 96, no. 6, doi:10.1002/jps.20822, ISSN 0022-3549, pages 1451 - 1467, XP055955545
OPPOSITION- Iacocca Ronald, Burcham Christopher, Hilden Lori, "Particle engineering: A strategy for establishing drug substance physical property specifications during small molecule development", Journal of Pharmaceutical Sciences, Elsevier Inc., US, US , (20100101), vol. 99, no. 1, doi:10.1002/jps.21801, ISSN 1520-6017, pages 51 - 75, XP009558780
OPPOSITION- Deliang Zhou, William R. Porter, Geoff G.Z. Zhang, "Chapter 5 - Drug Stability and Degradation Studies", Deliang Zhou, William R. Porter, Geoff G.Z. Zhang, Qiu Yihong, Developing solid oral dosage forms : pharmaceutical theory and practice, Burlington, MA, USA , Elsevier/Academic Press , (20081224), pages 87 - 124, doi:10.1016/B978-0-444-53242-8.00005-9, ISBN 978-0-444-53242-8, XP009553795
OPPOSITION- Ajit S. Narang, Venkatramana M. Rao, Krishnaswamy S. Raghavan, "Chapter 6 - Excipient Compatibility", Developing Solid Oral Dosage Forms Pharmaceutical Theory and Practice, US, Elsevier Science, (20090310), pages 125 - 145, doi:10.1016/B978-0-444-53242-8.00006-0, ISBN 0-444-53242-0, XP009558790
OPPOSITION- Amidon Gregory E., Pamela J. Secreast , Deanna Mudie, "8.2.2 Scanning Electron Microscopy", Amidon Gregory E., Pamela J. Secreast , Deanna Mudie, Qiu Yihong, Developing solid oral dosage forms : pharmaceutical theory and practice, Burlington, MA, USA , Elsevier/Academic Press , (20090101), pages 165 - 167, doi:10.1016/B978-0-444-53242-8.00008-4, ISBN 978-0-444-53242-8, XP093233816
OPPOSITION- Gregory E. Amidon , Pamela J. Secreast , Deanna Mudie, "Chapter 8 - Particle, Powder, and Compact Characterization", Developing Solid Oral Dosage Forms Pharmaceutical Theory and Practice, US, Elsevier Science, (20090310), pages 163 - 186, doi:10.1016/B978-0-444-53242-8.00008-4, ISBN 0-444-53242-0, XP009558791
OPPOSITION- Xiaorong He, "Chapter 18 - Integration of Physical, Chemical, Mechanical, and Biopharmaceutical Properties in Solid Oral Dosage Form Development", Xiaorong He, Qiu Yihong, Developing solid oral dosage forms : pharmaceutical theory and practice, Burlington, MA, USA , Elsevier/Academic Press , (20081224), pages 409 - 441, doi:10.1016/B978-0-444-53242-8.00018-7, ISBN 978-0-444-53242-8, XP009553797
OPPOSITION- P. Bowen, "Particle Size Distribution Measurement from Millimeters to Nanometers and from Rods to Platelets", JOURNAL OF DISPERSION SCIENCE AND TECHNOLOGY., Taylor and Francis Group, NEW YORK, NY, US, NEW YORK, NY, US , (20020101), vol. 23, no. 5, doi:10.1081/DIS-120015368, ISSN 0193-2691, pages 631 - 662, XP009102859
OPPOSITION- Shargel Leon, Yu Andrew B C, "Biopharmaceutics", Shargel Leon, Yu Andrew B C, J. Swarbrick, Encyclopedia of Pharmaceutical Technology, Third Edition, Informa Healthcare, (20070101), pages 208 - 227, doi:10.1081/E-EPT-100001912, ISBN 978-0-8493-9396-9, XP093233622
OPPOSITION- Moreton R. Christian, "Chapter 8: Excipient Interactions", Moreton R. Christian, Ashok Katdare; Mahesh V. Chaubal, Excipient development for pharmaceutical, biotechnology, and drug delivery systems, New York [u.a.] , Informa Healthcare , (20060728), pages 93 - 108, doi:10.1201/9781420004137-11, ISBN 978-0-8493-2706-3, XP093234006
OPPOSITION- Wei-Qin (Tony) Tong and Hong Wen, "Chapter 4: Preformulation Aspects of Insoluble Compounds", Wei-Qin (Tony) Tong and Hong Wen, Rong Liu (ed.), Water-insoluble drug formulation, 2nd ed., US, CRC Press/Taylor & Francis, (20080101), pages 61 - 90, doi:10.1201/9781420009552, ISBN 0-8493-9644-1, XP009558781
OPPOSITION- Patel Sarsvatkumar, Kaushal Aditya, Bansal Arvind, "Compression Physics in the Formulation Development of Tablets", Critical reviews in therapeutic drug carrier systems, CRC Press, US, US , (20060201), vol. 23, no. 1, doi:10.1615/CritRevTherDrugCarrierSyst.v23.i1.10, ISSN 2162-660X, pages 1 - 65, XP009558782
OPPOSITION- Sugano Kiyohiko, Okazaki Arimichi, Sugimoto Shohei, Tavornvipas Sumitra, Omura Atsushi, Mano Takashi, "Solubility and Dissolution Profile Assessment in Drug Discovery", DRUG METABOLISM AND PHARMACOKINETICS, JAPANESE SOCIETY FOR THE STUDY OF XENOBIOTICS (JSSX), TOKYO, JP, JP , (20070801), vol. 22, no. 4, doi:10.2133/dmpk.22.225, ISSN 1347-4367, pages 225 - 254, XP093234023

Download Citation Report

Get a free citation report including examiner, opposition, and international search citations.

Get Citation Report

Dossier Documents

The dossier documents provide a comprehensive record of the patent’s prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent’s legal journey and any challenges it may have faced during examination.

  • Date

    Description

  • Get instant alerts for new documents