Abstract: The present invention relates to pharmaceutical compositions of therapeutic proteins which are selected from the group comprising of naturally occurring or recombinant parathyroid hormone(PTH) and its analogues such as teriparatide PTH (1-34), PTH (1-37), PTH (1-38), PTH (1-41), PTH (1-84) and the like; or their pharmaceutically acceptable salts, enantiomers, polymorphs, crystalline forms or mixtures thereof; atleast one suitable buffer or buffer system maintaining a pH range from about 2 to about 8 having a concentration from about 0.001 mM to about 1M; atleast one stabilizer with or without atleast one preservative or combinations thereof in any ratio, optionally with pharmaceutically acceptable excipients.
FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
The Patents Rules, 2003
PROVISIONAL/COMPLETE SPECIFICATION (See section 10 and rule 13)
Title: PHARMACEUTICAL COMPOSITIONS OF THERAPEUTIC PROTEINS
Intas Biopharmaceuticals Limited
An Indian company having its registered office at:
Plot No: 423/P/A/GIDC
Sarkhej-Bavla Highway
Moraiya, Tal.: Sanand
Ahmedabad - 382 210
Gujarat, India
The following specification describes the invention.
-2-
PHARMACEUTICAL COMPOSITIONS OF THERAPEUTIC PROTEINS
ABSTRACT
The present invention relates to pharmaceutical compositions of therapeutic proteins which are selected from the group comprising of naturally occurring or recombinant parathyroid hormone(PTH) and its analogues such as teriparatide PTH (1-34), PTH (1-37), PTH (1-38), PTH (1-41), PTH (1-84) and the like; or their pharmaceutically acceptable salts, enantiomers, polymorphs, crystalline forms or mixtures thereof; atleast one suitable buffer or buffer system maintaining a pH range from about 2 to about 8 having a concentration from about 0.001 mM to about 1M; atleast one stabilizer with or without atleast one preservative or combinations thereof in any ratio, optionally with pharmaceutically acceptable excipients. The pharmaceutical compositions of the present invention can either be in a powder form and/or as a liquid dosage form. The processes for preparing the pharmaceutical compositions as discussed in context of the present invention and method(s) of use and treatment are also described.
Dated: 20tn day of December 2006
Signed @¥^ Gautam Bakshi
(IN/ PA- 1069) Manager
Intellectual Property Rights (IPR) Intas Biopharmaceuticals Limited Plot No: 423/P/A/GIDC Sarkhej-Bavla Highway Moraiya, Tal.: Sanand Ahmedabad-382 210 Gujarat, India.
| Section | Controller | Decision Date |
|---|---|---|
| # | Name | Date |
|---|---|---|
| 1 | 2097-mum-2006-abstract(17-6-2008).pdf | 2018-08-09 |
| 1 | 2097-mum-2006-form 2(title page)-(provisional)-(21-12-2006).pdf | 2006-12-21 |
| 2 | 2097-mum-2006-form 2(title page)-(complete)-(21-12-2006).pdf | 2006-12-21 |
| 2 | 2097-mum-2006-abstract(21-6-2007).pdf | 2018-08-09 |
| 3 | 2097-mum-2006-form 2(provisional)-(21-12-2006).pdf | 2006-12-21 |
| 3 | 2097-mum-2006-abstract.doc | 2018-08-09 |
| 4 | 2097-mum-2006-form 2(complete)-(21-12-2006).pdf | 2006-12-21 |
| 4 | 2097-mum-2006-abstract.pdf | 2018-08-09 |
| 5 | 2097-mum-2006-form 1(21-12-2006).pdf | 2006-12-21 |
| 5 | 2097-MUM-2006-CLAIMS(17-6-2008).pdf | 2018-08-09 |
| 6 | 2097-mum-2006-drawing(21-12-2006).pdf | 2006-12-21 |
| 6 | 2097-mum-2006-correspondance-received.pdf | 2018-08-09 |
| 7 | 2097-mum-2006-description(provisional)-(21-12-2006).pdf | 2006-12-21 |
| 7 | 2097-mum-2006-correspondence(17-6-2008).pdf | 2018-08-09 |
| 8 | 2097-mum-2006-description(complete)-(21-12-2006).pdf | 2006-12-21 |
| 8 | 2097-MUM-2006-CORRESPONDENCE(20-5-2013).pdf | 2018-08-09 |
| 9 | 2097-MUM-2006-CORRESPONDENCE(6-6-2011).pdf | 2018-08-09 |
| 9 | 2097-mum-2006-claims(21-12-2006).pdf | 2006-12-21 |
| 10 | 2097-mum-2006-abstract(21-12-2006).pdf | 2006-12-21 |
| 10 | 2097-mum-2006-correspondence(ipo)-(7-4-2008).pdf | 2018-08-09 |
| 11 | 2097-MUM-2006-CORRESPONDENCE(IPO)-(DECISION)-(16-8-2016).pdf | 2018-08-09 |
| 11 | 2097-MUM-2006-REPLY TO EXAMINATION REPORT-30-01-2015.pdf | 2015-01-30 |
| 12 | 2097-MUM-2006-CORRESPONDENCE(IPO)-(FER)-(8-2-2014).pdf | 2018-08-09 |
| 12 | 2097-MUM-2006-MARKED COPY-30-01-2015.pdf | 2015-01-30 |
| 13 | 2097-MUM-2006-CORRESPONDENCE(IPO)-(HEARING NOTICE)-(21-4-2016).pdf | 2018-08-09 |
| 13 | 2097-MUM-2006-FORM 3-30-01-2015.pdf | 2015-01-30 |
| 14 | 2097-mum-2006-description (provisional).pdf | 2018-08-09 |
| 14 | 2097-MUM-2006-FORM 26-30-01-2015.pdf | 2015-01-30 |
| 15 | 2097-MUM-2006-CLAIMS-30-01-2015.pdf | 2015-01-30 |
| 15 | 2097-MUM-2006-DESCRIPTION(COMPLETE)-(17-6-2008).pdf | 2018-08-09 |
| 16 | 2097-mum-2006-form 1(17-6-2008).pdf | 2018-08-09 |
| 16 | 2097-MUM-2006_EXAMREPORT.pdf | 2018-08-09 |
| 17 | 2097-MUM-2006-FORM 18(6-6-2011).pdf | 2018-08-09 |
| 17 | 2097-mum-2006-form-3.pdf | 2018-08-09 |
| 18 | 2097-MUM-2006-FORM 2(COMPLETE)-(17-6-2008).pdf | 2018-08-09 |
| 18 | 2097-mum-2006-form-2.pdf | 2018-08-09 |
| 19 | 2097-MUM-2006-FORM 2(TITLE PAGE)-(COMPLETE)-(17-6-2008).pdf | 2018-08-09 |
| 20 | 2097-mum-2006-form 2(title page)-(provisional)-(21-6-2007).pdf | 2018-08-09 |
| 20 | 2097-mum-2006-form-1.pdf | 2018-08-09 |
| 21 | 2097-MUM-2006-FORM 26(20-5-2013).pdf | 2018-08-09 |
| 21 | 2097-mum-2006-form 5(17-6-2008).pdf | 2018-08-09 |
| 22 | 2097-mum-2006-form 3(17-6-2008).pdf | 2018-08-09 |
| 23 | 2097-MUM-2006-FORM 26(20-5-2013).pdf | 2018-08-09 |
| 23 | 2097-mum-2006-form 5(17-6-2008).pdf | 2018-08-09 |
| 24 | 2097-mum-2006-form 2(title page)-(provisional)-(21-6-2007).pdf | 2018-08-09 |
| 24 | 2097-mum-2006-form-1.pdf | 2018-08-09 |
| 25 | 2097-MUM-2006-FORM 2(TITLE PAGE)-(COMPLETE)-(17-6-2008).pdf | 2018-08-09 |
| 26 | 2097-mum-2006-form-2.pdf | 2018-08-09 |
| 26 | 2097-MUM-2006-FORM 2(COMPLETE)-(17-6-2008).pdf | 2018-08-09 |
| 27 | 2097-mum-2006-form-3.pdf | 2018-08-09 |
| 27 | 2097-MUM-2006-FORM 18(6-6-2011).pdf | 2018-08-09 |
| 28 | 2097-mum-2006-form 1(17-6-2008).pdf | 2018-08-09 |
| 28 | 2097-MUM-2006_EXAMREPORT.pdf | 2018-08-09 |
| 29 | 2097-MUM-2006-CLAIMS-30-01-2015.pdf | 2015-01-30 |
| 29 | 2097-MUM-2006-DESCRIPTION(COMPLETE)-(17-6-2008).pdf | 2018-08-09 |
| 30 | 2097-mum-2006-description (provisional).pdf | 2018-08-09 |
| 30 | 2097-MUM-2006-FORM 26-30-01-2015.pdf | 2015-01-30 |
| 31 | 2097-MUM-2006-CORRESPONDENCE(IPO)-(HEARING NOTICE)-(21-4-2016).pdf | 2018-08-09 |
| 31 | 2097-MUM-2006-FORM 3-30-01-2015.pdf | 2015-01-30 |
| 32 | 2097-MUM-2006-CORRESPONDENCE(IPO)-(FER)-(8-2-2014).pdf | 2018-08-09 |
| 32 | 2097-MUM-2006-MARKED COPY-30-01-2015.pdf | 2015-01-30 |
| 33 | 2097-MUM-2006-CORRESPONDENCE(IPO)-(DECISION)-(16-8-2016).pdf | 2018-08-09 |
| 33 | 2097-MUM-2006-REPLY TO EXAMINATION REPORT-30-01-2015.pdf | 2015-01-30 |
| 34 | 2097-mum-2006-abstract(21-12-2006).pdf | 2006-12-21 |
| 34 | 2097-mum-2006-correspondence(ipo)-(7-4-2008).pdf | 2018-08-09 |
| 35 | 2097-mum-2006-claims(21-12-2006).pdf | 2006-12-21 |
| 35 | 2097-MUM-2006-CORRESPONDENCE(6-6-2011).pdf | 2018-08-09 |
| 36 | 2097-MUM-2006-CORRESPONDENCE(20-5-2013).pdf | 2018-08-09 |
| 36 | 2097-mum-2006-description(complete)-(21-12-2006).pdf | 2006-12-21 |
| 37 | 2097-mum-2006-correspondence(17-6-2008).pdf | 2018-08-09 |
| 37 | 2097-mum-2006-description(provisional)-(21-12-2006).pdf | 2006-12-21 |
| 38 | 2097-mum-2006-drawing(21-12-2006).pdf | 2006-12-21 |
| 38 | 2097-mum-2006-correspondance-received.pdf | 2018-08-09 |
| 39 | 2097-mum-2006-form 1(21-12-2006).pdf | 2006-12-21 |
| 39 | 2097-MUM-2006-CLAIMS(17-6-2008).pdf | 2018-08-09 |
| 40 | 2097-mum-2006-form 2(complete)-(21-12-2006).pdf | 2006-12-21 |
| 40 | 2097-mum-2006-abstract.pdf | 2018-08-09 |
| 41 | 2097-mum-2006-form 2(provisional)-(21-12-2006).pdf | 2006-12-21 |
| 42 | 2097-mum-2006-form 2(title page)-(complete)-(21-12-2006).pdf | 2006-12-21 |
| 42 | 2097-mum-2006-abstract(21-6-2007).pdf | 2018-08-09 |
| 43 | 2097-mum-2006-form 2(title page)-(provisional)-(21-12-2006).pdf | 2006-12-21 |
| 43 | 2097-mum-2006-abstract(17-6-2008).pdf | 2018-08-09 |