ZA200502693B

ZA200502693B - Pharmaceutical excipients comprising inorganic particles in association with an organic polymeric material and forming a solid reticulated matrix, compositions, manufacturing and use thereof.

Pharmaceutical excipients comprising inorganic particles in association with an organic polymeric material and forming a solid reticulated matrix, compositions, manufacturing and use thereof. Download PDF

Info

Publication number: ZA200502693B
Authority: ZA; South Africa
Prior art keywords: excipient; pharmaceutical; pores; mean width; primary
Prior art date: 2002-10-11

Application number

ZA200502693A

Other languages

English (en)

Inventor

Michael Tobyn

John Nicholas Staniforth

Cheryl Clinch

Matthew Paul Hearn

Dominic Walsh

Simon Robert Hall

Original Assignee

Vectura Ltd

Priority date

2002-10-11

Filing date

2005-04-04

Publication date

2005-10-24

2005-04-04 Application filed by Vectura Ltd filed Critical Vectura Ltd

2005-10-24 Publication of ZA200502693B publication Critical patent/ZA200502693B/en

Links

239000000546 pharmaceutical excipient Substances 0.000 title claims description 246
239000000463 material Substances 0.000 title claims description 148
229940124531 pharmaceutical excipient Drugs 0.000 title claims description 119
239000011159 matrix material Substances 0.000 title claims description 95
239000010954 inorganic particle Substances 0.000 title claims description 83
239000007787 solid Substances 0.000 title claims description 80
239000000203 mixture Substances 0.000 title claims description 36
238000004519 manufacturing process Methods 0.000 title claims description 15
239000011148 porous material Substances 0.000 claims description 186
239000003814 drug Substances 0.000 claims description 123
239000002245 particle Substances 0.000 claims description 122
238000000034 method Methods 0.000 claims description 116
239000000243 solution Substances 0.000 claims description 80
229940124597 therapeutic agent Drugs 0.000 claims description 74
-1 alkaline earth metal salt Chemical class 0.000 claims description 69
239000000825 pharmaceutical preparation Substances 0.000 claims description 69
229940127557 pharmaceutical product Drugs 0.000 claims description 69
239000013078 crystal Substances 0.000 claims description 56
VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 55
239000011147 inorganic material Substances 0.000 claims description 44
239000003826 tablet Substances 0.000 claims description 44
229910052784 alkaline earth metal Inorganic materials 0.000 claims description 43
239000013543 active substance Substances 0.000 claims description 42
QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 42
239000001506 calcium phosphate Substances 0.000 claims description 37
229910000389 calcium phosphate Inorganic materials 0.000 claims description 35
235000011010 calcium phosphates Nutrition 0.000 claims description 35
229920000642 polymer Polymers 0.000 claims description 35
238000004090 dissolution Methods 0.000 claims description 34
229910010272 inorganic material Inorganic materials 0.000 claims description 34
239000000047 product Substances 0.000 claims description 33
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 31
239000000843 powder Substances 0.000 claims description 30
229910000019 calcium carbonate Inorganic materials 0.000 claims description 29
230000002776 aggregation Effects 0.000 claims description 25
239000007864 aqueous solution Substances 0.000 claims description 25
235000010216 calcium carbonate Nutrition 0.000 claims description 22
229920001282 polysaccharide Polymers 0.000 claims description 21
239000005017 polysaccharide Substances 0.000 claims description 21
229920001285 xanthan gum Polymers 0.000 claims description 21
235000010493 xanthan gum Nutrition 0.000 claims description 21
239000000230 xanthan gum Substances 0.000 claims description 21
229940082509 xanthan gum Drugs 0.000 claims description 21
244000025254 Cannabis sativa Species 0.000 claims description 20
229910019142 PO4 Inorganic materials 0.000 claims description 19
239000008184 oral solid dosage form Substances 0.000 claims description 19
229920002307 Dextran Polymers 0.000 claims description 18
239000002775 capsule Substances 0.000 claims description 18
NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 18
239000010452 phosphate Substances 0.000 claims description 18
238000004220 aggregation Methods 0.000 claims description 17
238000010438 heat treatment Methods 0.000 claims description 16
238000001556 precipitation Methods 0.000 claims description 16
150000003839 salts Chemical class 0.000 claims description 16
239000002904 solvent Substances 0.000 claims description 15
BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims description 14
239000007791 liquid phase Substances 0.000 claims description 14
239000004816 latex Substances 0.000 claims description 13
229920000126 latex Polymers 0.000 claims description 13
239000003085 diluting agent Substances 0.000 claims description 12
UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 11
VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 11
239000001110 calcium chloride Substances 0.000 claims description 11
229910001628 calcium chloride Inorganic materials 0.000 claims description 11
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OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims description 8
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150000001450 anions Chemical class 0.000 claims description 6
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235000011132 calcium sulphate Nutrition 0.000 claims description 4
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150000002500 ions Chemical class 0.000 claims description 4
239000000377 silicon dioxide Substances 0.000 claims description 4
OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 3
238000007605 air drying Methods 0.000 claims description 3
150000001342 alkaline earth metals Chemical class 0.000 claims description 3
229960000074 biopharmaceutical Drugs 0.000 claims description 3
229910052791 calcium Inorganic materials 0.000 claims description 3
239000000378 calcium silicate Substances 0.000 claims description 3
229910052918 calcium silicate Inorganic materials 0.000 claims description 3
235000012241 calcium silicate Nutrition 0.000 claims description 3
OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 claims description 3
238000004132 cross linking Methods 0.000 claims description 3
239000011146 organic particle Substances 0.000 claims description 3
238000002560 therapeutic procedure Methods 0.000 claims description 3
VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims description 2
239000003124 biologic agent Substances 0.000 claims description 2
239000001175 calcium sulphate Substances 0.000 claims description 2
150000005323 carbonate salts Chemical class 0.000 claims description 2
239000013043 chemical agent Substances 0.000 claims description 2
230000005670 electromagnetic radiation Effects 0.000 claims description 2
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150000004676 glycans Chemical class 0.000 claims 5
238000003745 diagnosis Methods 0.000 claims 1
229910017053 inorganic salt Inorganic materials 0.000 claims 1
229940079593 drug Drugs 0.000 description 41
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238000002360 preparation method Methods 0.000 description 27
238000001878 scanning electron micrograph Methods 0.000 description 25
CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 24
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HYIMSNHJOBLJNT-UHFFFAOYSA-N nifedipine Chemical compound COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1[N+]([O-])=O HYIMSNHJOBLJNT-UHFFFAOYSA-N 0.000 description 22
229960001597 nifedipine Drugs 0.000 description 22
IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 15
239000006260 foam Substances 0.000 description 15
235000021317 phosphate Nutrition 0.000 description 15
150000004804 polysaccharides Chemical class 0.000 description 15
229910052588 hydroxylapatite Inorganic materials 0.000 description 14
239000007788 liquid Substances 0.000 description 14
XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 14
238000006243 chemical reaction Methods 0.000 description 13
HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 12
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239000011324 bead Substances 0.000 description 11
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239000011734 sodium Substances 0.000 description 11
CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 10
235000011148 calcium chloride Nutrition 0.000 description 10
229960002713 calcium chloride Drugs 0.000 description 10
HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 10
239000011163 secondary particle Substances 0.000 description 10
DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 9
239000000314 lubricant Substances 0.000 description 9
229910052751 metal Inorganic materials 0.000 description 9
239000002184 metal Substances 0.000 description 9
238000009736 wetting Methods 0.000 description 9
GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 8
PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 8
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DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 7
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KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 6
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CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 6
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