KR20010043600A - 발포 제제 - Google Patents
발포 제제 Download PDFInfo
- Publication number
- KR20010043600A KR20010043600A KR1020007012745A KR20007012745A KR20010043600A KR 20010043600 A KR20010043600 A KR 20010043600A KR 1020007012745 A KR1020007012745 A KR 1020007012745A KR 20007012745 A KR20007012745 A KR 20007012745A KR 20010043600 A KR20010043600 A KR 20010043600A
- Authority
- KR
- South Korea
- Prior art keywords
- sugar
- components
- appropriate
- foam
- component
- Prior art date
Links
- 238000002360 preparation method Methods 0.000 title claims description 3
- 239000000203 mixture Substances 0.000 claims abstract description 47
- 239000006260 foam Substances 0.000 claims abstract description 23
- 238000009472 formulation Methods 0.000 claims abstract description 23
- 235000000346 sugar Nutrition 0.000 claims abstract description 19
- 239000003765 sweetening agent Substances 0.000 claims abstract description 19
- 235000021092 sugar substitutes Nutrition 0.000 claims abstract description 18
- 150000005846 sugar alcohols Chemical class 0.000 claims abstract description 17
- 239000003814 drug Substances 0.000 claims abstract description 8
- 229940079593 drug Drugs 0.000 claims abstract description 8
- 150000008163 sugars Chemical class 0.000 claims abstract description 8
- 238000000034 method Methods 0.000 claims description 25
- -1 H2 block Substances 0.000 claims description 14
- 239000000155 melt Substances 0.000 claims description 11
- 239000000126 substance Substances 0.000 claims description 11
- 239000013543 active substance Substances 0.000 claims description 9
- 238000005187 foaming Methods 0.000 claims description 9
- 230000002378 acidificating effect Effects 0.000 claims description 8
- 238000002844 melting Methods 0.000 claims description 7
- 230000008018 melting Effects 0.000 claims description 7
- 239000003795 chemical substances by application Substances 0.000 claims description 6
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 5
- 239000011149 active material Substances 0.000 claims description 4
- 238000001816 cooling Methods 0.000 claims description 4
- 238000000227 grinding Methods 0.000 claims description 3
- 239000000463 material Substances 0.000 claims description 3
- 239000011159 matrix material Substances 0.000 claims description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 2
- 208000019695 Migraine disease Diseases 0.000 claims description 2
- OMOVVBIIQSXZSZ-UHFFFAOYSA-N [6-(4-acetyloxy-5,9a-dimethyl-2,7-dioxo-4,5a,6,9-tetrahydro-3h-pyrano[3,4-b]oxepin-5-yl)-5-formyloxy-3-(furan-3-yl)-3a-methyl-7-methylidene-1a,2,3,4,5,6-hexahydroindeno[1,7a-b]oxiren-4-yl] 2-hydroxy-3-methylpentanoate Chemical compound CC12C(OC(=O)C(O)C(C)CC)C(OC=O)C(C3(C)C(CC(=O)OC4(C)COC(=O)CC43)OC(C)=O)C(=C)C32OC3CC1C=1C=COC=1 OMOVVBIIQSXZSZ-UHFFFAOYSA-N 0.000 claims description 2
- 230000000954 anitussive effect Effects 0.000 claims description 2
- 229940069428 antacid Drugs 0.000 claims description 2
- 239000003159 antacid agent Substances 0.000 claims description 2
- 239000003242 anti bacterial agent Substances 0.000 claims description 2
- 230000003266 anti-allergic effect Effects 0.000 claims description 2
- 230000001088 anti-asthma Effects 0.000 claims description 2
- 239000000924 antiasthmatic agent Substances 0.000 claims description 2
- 239000003472 antidiabetic agent Substances 0.000 claims description 2
- 239000000739 antihistaminic agent Substances 0.000 claims description 2
- 229940124584 antitussives Drugs 0.000 claims description 2
- 239000003172 expectorant agent Substances 0.000 claims description 2
- 230000003419 expectorant effect Effects 0.000 claims description 2
- 229910052500 inorganic mineral Inorganic materials 0.000 claims description 2
- 239000008141 laxative Substances 0.000 claims description 2
- 239000003589 local anesthetic agent Substances 0.000 claims description 2
- 239000011707 mineral Substances 0.000 claims description 2
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- 239000002325 prokinetic agent Substances 0.000 claims description 2
- 230000002889 sympathetic effect Effects 0.000 claims description 2
- 229930003231 vitamin Natural products 0.000 claims description 2
- 235000013343 vitamin Nutrition 0.000 claims description 2
- 239000011782 vitamin Substances 0.000 claims description 2
- 229940088594 vitamin Drugs 0.000 claims description 2
- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical compound C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 claims 1
- 239000008186 active pharmaceutical agent Substances 0.000 claims 1
- 230000000202 analgesic effect Effects 0.000 claims 1
- 230000001458 anti-acid effect Effects 0.000 claims 1
- 230000003178 anti-diabetic effect Effects 0.000 claims 1
- 230000001387 anti-histamine Effects 0.000 claims 1
- 230000003276 anti-hypertensive effect Effects 0.000 claims 1
- 230000001062 anti-nausea Effects 0.000 claims 1
- 230000003115 biocidal effect Effects 0.000 claims 1
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 claims 1
- 230000002475 laxative effect Effects 0.000 claims 1
- 230000000506 psychotropic effect Effects 0.000 claims 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 21
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 18
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 10
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 9
- 235000017557 sodium bicarbonate Nutrition 0.000 description 9
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 9
- YGSDEFSMJLZEOE-UHFFFAOYSA-N salicylic acid Chemical compound OC(=O)C1=CC=CC=C1O YGSDEFSMJLZEOE-UHFFFAOYSA-N 0.000 description 8
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 7
- 235000015165 citric acid Nutrition 0.000 description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 7
- 239000000811 xylitol Substances 0.000 description 7
- 235000010447 xylitol Nutrition 0.000 description 7
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 7
- 229960002675 xylitol Drugs 0.000 description 7
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 5
- 239000002253 acid Substances 0.000 description 5
- 239000000796 flavoring agent Substances 0.000 description 5
- BSYNRYMUTXBXSQ-FOQJRBATSA-N 59096-14-9 Chemical compound CC(=O)OC1=CC=CC=C1[14C](O)=O BSYNRYMUTXBXSQ-FOQJRBATSA-N 0.000 description 4
- 108010011485 Aspartame Proteins 0.000 description 4
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 4
- 229960005070 ascorbic acid Drugs 0.000 description 4
- 235000010323 ascorbic acid Nutrition 0.000 description 4
- 239000011668 ascorbic acid Substances 0.000 description 4
- 239000000605 aspartame Substances 0.000 description 4
- 235000010357 aspartame Nutrition 0.000 description 4
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 description 4
- 229960003438 aspartame Drugs 0.000 description 4
- 238000001125 extrusion Methods 0.000 description 4
- 235000019634 flavors Nutrition 0.000 description 4
- 239000008187 granular material Substances 0.000 description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 4
- FJKROLUGYXJWQN-UHFFFAOYSA-N papa-hydroxy-benzoic acid Natural products OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 description 4
- 229960004889 salicylic acid Drugs 0.000 description 4
- 239000001509 sodium citrate Substances 0.000 description 4
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 4
- 229930195725 Mannitol Natural products 0.000 description 3
- 229940030600 antihypertensive agent Drugs 0.000 description 3
- 239000002220 antihypertensive agent Substances 0.000 description 3
- 239000004615 ingredient Substances 0.000 description 3
- 239000000594 mannitol Substances 0.000 description 3
- 235000010355 mannitol Nutrition 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- 239000003826 tablet Substances 0.000 description 3
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 description 2
- SRBFZHDQGSBBOR-IOVATXLUSA-N D-xylopyranose Chemical compound O[C@@H]1COC(O)[C@H](O)[C@H]1O SRBFZHDQGSBBOR-IOVATXLUSA-N 0.000 description 2
- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 description 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 2
- 229960004308 acetylcysteine Drugs 0.000 description 2
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- 238000007664 blowing Methods 0.000 description 2
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 description 2
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- 229920002678 cellulose Polymers 0.000 description 2
- 235000010980 cellulose Nutrition 0.000 description 2
- OROGSEYTTFOCAN-DNJOTXNNSA-N codeine Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)=C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC OROGSEYTTFOCAN-DNJOTXNNSA-N 0.000 description 2
- KWGRBVOPPLSCSI-UHFFFAOYSA-N d-ephedrine Natural products CNC(C)C(O)C1=CC=CC=C1 KWGRBVOPPLSCSI-UHFFFAOYSA-N 0.000 description 2
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- LNEPOXFFQSENCJ-UHFFFAOYSA-N haloperidol Chemical compound C1CC(O)(C=2C=CC(Cl)=CC=2)CCN1CCCC(=O)C1=CC=C(F)C=C1 LNEPOXFFQSENCJ-UHFFFAOYSA-N 0.000 description 2
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- 239000000905 isomalt Substances 0.000 description 2
- 235000010439 isomalt Nutrition 0.000 description 2
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- VQHSOMBJVWLPSR-JVCRWLNRSA-N lactitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-JVCRWLNRSA-N 0.000 description 2
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- AQHHHDLHHXJYJD-UHFFFAOYSA-N propranolol Chemical compound C1=CC=C2C(OCC(O)CNC(C)C)=CC=CC2=C1 AQHHHDLHHXJYJD-UHFFFAOYSA-N 0.000 description 2
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Abstract
본 발명은 가융성 당, 당 알콜 및(또는) 당 대용물을 함유하는, 보관시 특히 안정한 의약-함유 발포 제제에 관한 것이다.
Description
본 발명은 제제 성분의 적어도 일부를 용융시키는 의약-함유 발포 제제의 제조 방법 및 이 방법에 의해 얻을 수 있는 발포 제제에 관한 것이다.
예를 들어, 발포 산제 또는 발포 정제와 같은 발포 제제는 예를 들면 흡수 시간이 길거나 위 점막을 자극하는 경향이 있는 활성 물질들의 불리한 특성을 완화시킬 수 있는 제형이다. 따라서, 의약-함유 발포 제제의 보급이 증가되고 있다. 이들은 보통 3 내지 4 단계로 제조되는데, 즉,
a) CO2공여체 및 CO2-방출 산성 성분으로 구성된 발포 조성물을 과립화하는 단계,
b) 기타 성분들 (활성 물질 및 기타 보조 물질)을 혼합하는 단계,
c) 적절한 경우, a) 및 b) 단계로부터 얻어진 성분들을 혼합하는 단계,
d) c) 단계에서 얻어진 혼합물을 타정하는 단계
에 의해 제조된다.
CO2공여체와 산성 성분 모두 직접 타정하는 것이 비교적 적합하지 않기 때문에, 과거에는 발포 조성물 성분들을 적절한 경우 타정 전에 활성 물질과 함께 과립화하였다 (예를 들면 DE-OS 제22 16 072호 비교). 그러나, 이런 방법으로 제조된 발포 정제의 안정성은 여전히 만족스럽지 못하다. 완충 물질 및 향미제 (항상 그런 것은 아니지만, 보통은 여러가지 상이한 개별 화합물로 구성됨)를 추가로 사용하는 경우에는 특히 물에 대해 민감해져서 보관시 탈색, 팽창 및 분해 반응을 일으키게 된다. 이러한 원치 않는 반응을 피하기 위해, 발포 제제를 종종 금속 호일로 밀봉한다. 이러한 조치가 저장 수명을 연장할 수는 있지만, 장기간 보관시에는 금속 호일 사셋의 팽창을 신뢰성있게 막는 것이 가능하지 않다.
놀랍게도, 본 발명에 와서야 제제 성분을 용융시키는 방법에 의해 의약-함유 발포 제제의 안정성을 증가시킬 수 있다는 것을 알아내었다.
따라서, 본 발명은
A. (i) CO2공여체 및
(ii) 산성 성분을 함유하는 발포 조성물,
B. 제약 활성 물질, 및
C. 보조 물질
로 구성된 의약-함유 발포 제제의 제조 방법으로서, A(i)와 A(ii)의 두 성분, 및 적절한 경우 다른 발포 제제 성분 중 1종 이상을 용융된 성분 C (당 및(또는) 당 알콜 및(또는) 당 대용물) 중에 분산시키고, 적절한 경우 얻어진 혼합물을 타정하는 것을 특징으로 하는, 의약-함유 발포 제제의 제조 방법에 관한 것이다.
본 발명은 적절한 경우 나머지 발포 제제 성분 중 하나, 다수 또는 모두를 용융물에 분산시키는 것을 수반한다.
바람직한 방법은
- 냉각 중에, 또는 냉각 후에 성분 A(i) 및(또는) A(ii) 및 성분 C (가융성 당 및(또는) 당 알콜 및(또는) 당 대용물)의 용융물을 분쇄하고,
- 분쇄한 생성물을 활성 물질 B, 적절한 경우 여전히 필요한 발포 조성물 A의 성분 (i) 또는 (ii), 및 적절한 경우 추가의 보조 물질 C와 혼합하고,
- 적절한 경우 얻어진 혼합물을 타정하는 것을 특징으로 한다.
바람직한 CO2공여체 A(i)로는 알칼리 금속 및 알칼리 토금속 탄산염 및 중탄산염, 특히 탄산 및 중탄산 나트륨 및 칼륨, 및 탄산 마그네슘 및 칼슘이 포함된다.
이산화탄소를 CO2공여체 A(i)로부터 유리시키는 산성 성분 A(ii)로는 성분 A(i)로부터 이산화탄소를 유리시키기에 충분히 강한 생리학적 허용가능한 산 (소위 "산성화제"라 함)이 적합하며, 이러한 산은 25 ℃에서의 제1 평형 지수 pKa가 1 내지 7, 바람직하게는 2 내지 6이다. 바람직한 산성 성분 A(i)로는 탄소수 3 내지 8, 바람직하게는 4 내지 6, 분자당 카르복실기 2 내지 4개를 갖는 아스코르브산 및 다염기성 카르복실산, 예를 들면 비타민 C, 말산, 시트르산, 타르타르산 및 그의 혼합물이 포함된다.
적합한 제약 활성 물질 C로는 진통제 (예를 들면, 이부프로펜, 케토프로펜, 파라세타몰, 아세틸살리실산, COX2), 억제제 (예를 들면, 니메술리드, 멜록시캄, 나프록센, 프로피페나존, 메타미졸), 제산제 (예를 들면, 히드로탈사이트, 마갈드레이트, 탄산칼슘), 항천식제/기관지 진경약 (예를 들면, 살부타몰, 툴로부테롤, 테르부탈린, 크로모글릭산, 케토티펜, 테오필린), 항생제 (예를 들면, 퀴놀론, 테트라시클린, 세팔로스포린, 페니실린, 마크롤리드, 술포나미드, 폴리펩티드), 향정신제 (예를 들면, 벤조디아제핀, 할로페리돌, 아미트립틸린, 카바마제핀), 항류마티스제 (예를 들면, 페닐부타존, 인도메타신, 디클로페낙, 피록시캄), 항당뇨병제 (예를 들면, 메트포르민, 글리벤클라미드, 아카르보스, 글리속세피드), 항알러지제/항히스타민제 (예를 들면, 아스테미졸, 테르페나딘, 로라타딘, 클레마스틴, 바미핀, 세티리진), 항저혈압제 (예를 들면, 에틸에프린, 노르펜에프린, 디히드로에르고타민 메실레이트), 진해제 (예를 들면, 코데인, 덱스트로메토르판, 클로부틴올, 드로프로피진), 항고혈압제 (예를 들면, 프로프라놀올, 아테놀올, 메토프롤올, 프라조신과 같은 베타 블록제), 항고혈압제 (예를 들면, 니페디핀, 니트렌디핀, 딜티아젬, 베라파밀, 페로디핀, 니모디핀과 같은 칼슘 채널 블록제), 완하제 (예를 들면, 나트륨 피코술페이트, 락툴로스, 락티톨), 점액용해제/거담약 (예를 들면, 암브록솔, 브롬헥신, 구아이페네신, 아세틸시스테인, 카르보시스테인), H2 블록제 (예를 들면, 라니티딘, 파모티딘, 피렌제핀), 국소 마취제 (예를 들면, 벤조카인, 리도카인, 프로카인), 구토방지제/프로키네틱제 (예를 들면, 메토클로프라미드, 돔페리돈, 메클로진, 디멘히드리네이트), 지방 저하제 (예를 들면, 페노피브레이트, 베자피브레이트, 프라바스타틴, 플루바스타틴), 편두통에 효과적인 제제 (예를 들면, 카페인, 디히드로에르고타민, 에르고타민, 수마트립탄, 피조티펜), 교감 신경 흥분제 (예를 들면, 슈도에페드린, 폴레드린), 비타민 및 미네랄이 포함된다.
본 발명에 따른 방법에서 적어도 부분적으로 용융되어야 하는 보조 물질 C는 단독 물질로서 및(또는) 혼합물로서, 융점이 바람직하게는 30 내지 200 ℃, 보다 바람직하게는 40 내지 160 ℃이다. 이런 형태의 보조 물질들은 수용성인 것이 바람직한데, 즉, 이들은 일반적으로 20 ℃에서의 수용해도가 물 100 ml 당 10 g 이상, 바람직하게는 30 g 이상, 특히 40 g 이상이다.
가융성 당 C에는 예를 들면 글루코오스, 만노오스, 갈락토오스, 아라비노오스, 크실로오스, 리보오스와 같은 모노사카라이드 및 수크로오스, 락토오스, 말토오스와 같은 디사카라이드가 포함된다. 본 발명에 바람직한 당 알콜 C에는 크실리톨, 만니톨, 소르비톨, 이소말트, 락티톨, 에리트리톨, 트레이톨, 리비톨, 아라비톨 및 둘시톨이 포함된다. 이런 종류의 바람직한 당 알콜이 유럽 특허 출원 공보 제435 450호 등에 기재되어 있다. 본 발명의 목적상 용어 "당 대용물"에는 당 알콜이 포함되지 않는다. 바람직한 당 대용물 C에는 아세술팜, 아스파르탐, 사카린, 나트륨 시클라메이트가 포함된다.
추가의 보조 물질 C에는 향미제, 감미제, 윤활제, 유동 조절제, 붕해제 및 증량제, 예를 들면 전분 및 전분 유도체, 셀룰로오스 및 셀룰로오스 유도체, 폴리에틸렌이 포함된다.
본 발명에 따라 얻을 수 있는 발포 제제는 성분들을 다양한 양의 비율로 함유할 수 있으며, 바람직한 발포 제제는 (각 경우 중량부로)
A: 5 내지 95, 바람직하게는 10 내지 80,
B: 5 내지 95, 바람직하게는 40 내지 60,
C: (당, 당 알콜 또는 당 대용물) 1 내지 60, 바람직하게는 15 내지 30, 및 적절한 경우, (다른 보조 물질) 1 내지 50를 함유한다.
발포 조성물 A는 각 경우 A를 기준으로 CO2공여체 30 내지 70 중량% 및 산성 성분 70 내지 30 중량%를 함유하는 것이 바람직하다.
발포 조성물 A (성분)와 C (가융성 당 및(또는) 당 알콜 및(또는) 당 대용물)의 용융물은 예를 들어 발포 조성물 A (성분)를 C (당 및(또는) 당 알콜 및(또는) 당 대용물)의 용융물에 가하거나, 또는 발포 조성물 A (성분)와 C (당 및(또는) 당 알콜 및(또는) 당 대용물)의 혼합물을 용융시켜서 제조할 수 있다.
그러나, 본 발명에 따른 방법은, 모든 성분들을 예비 혼합하여 함께 가열하거나, 또는 당 및(또는) 당 알콜 및(또는) 당 대용물을 용융시키고, 나머지 성분들을 용융물 중에서 (동시에 또는 연속적으로) 분산시키는 방법에 의해 발포 제제의 모든 성분들을 분산을 위해 융용된 당 및(또는) 당 알콜 및(또는) 당 대용물와 접촉시킴으로써 수행할 수도 있다. 물론, 상기한 변형 방법들을 혼합 형태로 사용하는 것도 가능하다.
사살상 임의의 적합한 방법으로 용융물을 제조할 수 있다. 예를 들면, 가열용 교반기를 사용할 수 있다. 국제 특허 출원 공개 제92/6679호에서 설명된 용융-과립법을 사용할 수도 있다. 유럽 특허 출원 공개 제686 392호에 설명된 용융 압출법이 바람직한 방법이다. 압출을 위해 시판되는 1축 및 2축 압출기를 사용할 수 있다. 또한, 계량 공급기를 통해 출발 물질을 압출기로 공급할 수도 있다. 용융 온도는 30 내지 200 ℃일 수 있다. 압력은 다이 구경 (바람직하게는 0.5 내지 5 mm) 및 회전 속도 (바람직하게는 5 내지 400 회전수/분)에 따라 2 내지 200 bar가 바람직할 수 있다. 산출량은 폭넓은 범위 내에서 다양할 수 있지만, 1 내지 100 kg/시간이 바람직하다. 적절한 경우, 압출물을 냉각시킨다. 분쇄 후, 이들을 활성 물질 B, 적절한 경우 추가의 보조 물질 C와 혼합해서 적절한 경우 타정할 수 있다.
본 발명에 따른 방법에서는 물 또는 공정 조건하에서 휘발성인 유기 용매를 사용하지 않는 것이 바람직한데, 즉, 공정 중에 물 및 용매가 존재하지 않는 것이 바람직하다. 다시 말하면, 이 방법은 정확히 DE-OS 제22 16 072호 또는 문헌 [Acta Pharm. Suec., 24, (2), 84, 1987; Drug Dev. Ind. Pharm. 13, (9-11), 1891-1913, 1987; Drug Dev. Ind. Pharm. 14, (13), 1791-98, 1988] 기재된 방법이 아니다.
본 발명에 따른 방법을 연속식 또는 회분식으로 수행할 수 있다.
본 발명에 따른 방법에서는 성분 A(i) 및(또는) A(ii), 및 적절한 경우 추가의 발포 제제 성분을 성분 C (가융성 당, 당 알콜 또는 당 대용물)에 분산시키는데, 즉, 가융성 성분 C는 A(i) 및(또는) A(ii), 및 적절한 경우 추가의 발포 제제 성분들이 혼입되어 있는 매트릭스를 형성한다.
따라서, 본 발명은 또한
A. (i) CO2공여체 및
(ii) 산성 성분을 함유하는 발포 조성물,
B. 제약 활성 물질, 및
C. 보조 물질
로 구성되고, 보조 물질 C는 가융성 당 및(또는) 당 알콜 및(또는) 당 대용물을 함유하며, 성분 A(i) 및(또는) A(ii)는 가융성 당 및(또는) 당 알콜 및(또는) 당 대용물의 매트릭스 내에 분산되어 있는 것을 특징으로 하는 발포 제제에 관한 것이다.
하기의 실시예에서의 데이터 분율은 각 경우 중량을 기준으로 한 것이다.
＜실시예 1＞
압출된 성분 A(i) 및 A(ii)를 따로 포함하는 발포 제제
압출물 I
만니톨 및 중탄산나트륨을 하기 표에 나타낸 비율로 혼합하였다. 이 혼합물을 속도가 30 rpm이고 다이 직경이 1 mm인 2축 압출기 (Leistriz Micro 27/40D)에서 처리하였다. 다이는 축의 외경 주변에 배열되어 있다. 혼합 구역 및 다이의 온도는 80 ℃였다. 압출물을 냉각 벨트 상에서 냉각한 후, 진동하는 체를 사용하여 분쇄하였다.
압출물 II
만니톨, 시트르산 및 시트르산 나트륨을 혼합하고, 압출하고, 상기와 같이 추가 처리하였다.
| 압출물 I | 압출물 II | |
| 만니톨 | 60% | 60% |
| 중탄산 나트륨 | 40% | |
| 시트르산 | 6.7% | |
| 시트르산 나트륨 | 33.3% |
단일 투여량을 기준으로, 압출물 I 125 mg 및 압출물 II 150 mg을 아세틸살리실산 500 mg, 아스파르탐 5 mg 및 오렌지 향료 30 mg과 혼합하고, 사셋에 패킹하였다.
＜실시예 2＞
실시예 1과 유사하게, 다이 직경이 0.8 mm이고 회전 속도가 26 rpm인 압출기로 70 ℃의 온도에서 압출물 I 및 압출물 II를 압출하였다.
| 압출물 I | 압출물 II | |
| 크실리톨 | 60% | 60% |
| 중탄산 나트륨 | 40% | |
| 시트르산 | 40% |
단일 투여량을 기준으로, 압출물 I 125 mg 및 압출물 II 150 mg을 아세틸살리실산 500 mg, 사카린 4 mg 및 만다린 향료 30 mg과 혼합하고, 사셋에 패킹하였다.
＜실시예 3＞
실시예 2와 유사하게, 다이 직경이 1 mm이고 회전 속도가 34 rpm인 압출기로 60 ℃의 온도에서 압출물 I 및 압출물 II를 압출하였다.
| 압출물 I | 압출물 II | |
| 크실리톨 | 30% | 30% |
| 중탄산 나트륨 | 70% | |
| 시트르산 | 70% |
단일 투여량을 기준으로, 압출물 I 및 압출물 II 각각 125 mg을 아스코르브산 150 mg 및 클로르페니라민 2.5 mg과 혼합하고, 사셋에 패킹하였다.
＜실시예 4＞
실시예 2와 유사하게, 다이 직경이 2 mm이고 회전 속도가 35 rpm인 압출기로 60 ℃의 온도에서 압출물 I 및 압출물 II를 압출하였다.
| 압출물 I | 압출물 II | |
| 이소말트 | 60% | |
| 크실리톨 | 60% | |
| 중탄산 칼륨 | 40% | |
| 아스코르브산 | 40% |
단일 투여량을 기준으로, 압출물 I 125 mg 및 압출물 II 250 mg을 아세틸살리실산 500 mg, 사카린 5 mg, 아스파르탐 2 mg 및 오렌지 향료 30 mg과 혼합하고, 사셋에 패킹하였다.
＜실시예 5＞
실시예 1과 유사하게, 다이 직경이 1 mm이고 회전 속도가 35 rpm인 압출기로 60 ℃의 온도에서 압출물 I 및 압출물 II를 압출하였다.
| 압출물 I | 압출물 II | |
| 만니톨 | 60% | 60% |
| 중탄산 나트륨 | 20% | |
| 탄산 칼슘 | 20% | |
| 아스코르브산 | 40% |
단일 투여량을 기준으로, 각경우 압출물 I 1500 mg 및 압출물 II 750 mg을 아스파르탐 5 mg 및 적건포도 향료 10 mg과 혼합하고, 사셋에 패킹하였다.
＜실시예 6＞
1종의 압출 성분, 즉, A(ii)만을 갖는 제제
| 실시예 2의 압출물 II | 1200 mg |
| 파모티딘 | 10 mg |
| 중탄산 나트륨 | 400 mg |
| 탄산 나트륨 | 100 mg |
| 스테아르산 마그네슘 | 20 mg |
실시예 1과 유사하게, 산 성분만을 압출하고, 알칼리성 발포 성분 및 활성 물질을 함께 혼합하였다. 후속적으로, 스테아르산 마그네슘을 혼합하였다. 이 혼합물을 발포 정제로 가압하였다.
＜실시예 7＞
A(i) 및 A(ii)의 조합 압출물
| 크실리톨 | 60% |
| 시트르산 나트륨 | 14% |
| 중탄산 나트륨 | 23% |
| 시트르산 | 3% |
제조 방법:
A) 실시예 1과 유사하게 압출하거나, 또는
B) 약 120 ℃에서 크실리톨을 용융시키고, 계량하고, 성분들 중에서 연속적으로 교반하였다. 냉각 후, 용융물 케이크를 분쇄하였다.
단일 투여량을 기준으로, 각 경우 얻어진 압출물 600 mg, 아세틸시스테인 200 mg 및 레몬 향료 10 mg을 혼합하였다. 얻어진 분말 혼합물을 사셋에 패킹하였다.
＜실시예 8＞
크실리톨 54%, 슈도에페드린 6%, 시트르산 나트륨 14%, 중탄산 나트륨 23% 및 시트르산 3%의 혼합물을 실시예 1과 유사하게 압출하였다. 압출물을 분쇄하고 패킹하였다.
ASA를 함유하는 발포 제제의 안정성 비교
수증기에 대해 불투과성인 포장지 내 25 ℃에서 3달간 보관 후 분해 생성물 살리실산 (SA)을 측정하였다.
| 초기 SA 함량 | 3달 후 SA 함량 | |
| 미분된*ASA 발포 과립 | 0.02% | 1.61% |
| 미분된xx(압출)ASA 발포 과립 | 0.04% | 0.18% |
| 미분된*ASA 발포 정제 | 0.3% | 1.83% |
| 미분되지 않은*ASA 발포 과립 | 0.17% | 0.8% |
| * 과립이 통상의 기술 (비교 시험)로 제조됨xx 본 발명에 따른 방법으로 제조됨 |
Claims (7)
- A. (i) CO2공여체 및(ii) 산성 성분을 함유하는 발포 조성물,B. 제약 활성 물질, 및C. 보조 물질로 구성된 의약-함유 발포 제제의 제조 방법으로서, A(i)와 A(ii)의 두 성분, 및 적절한 경우 다른 발포 제제 성분 중 1종 이상을 용융된 성분 C (당 및(또는) 당 알콜 및(또는) 당 대용물) 중에 분산시키고, 적절한 경우 얻어진 혼합물을 타정하는 것을 특징으로 하는, 의약-함유 발포 제제의 제조 방법.
- 제1항에 있어서,- 냉각 중에, 또는 냉각 후에 성분 A(i) 및(또는) A(ii) 및 성분 C (가융성 당 및(또는) 당 알콜 및(또는) 당 대용물)의 용융물을 분쇄하고,- 분쇄한 생성물을 활성 물질 B, 적절한 경우 여전히 필요한 발포 조성물 A의 성분 (i) 또는 (ii), 및 적절한 경우 추가의 보조 물질 C와 혼합하고,- 적절한 경우 얻어진 혼합물을 타정하는 방법.
- 제1항에 있어서, 용융을 위해 압출기를 사용하는 방법.
- 제1항에 있어서, 제약 활성 물질 B가 진통제, 제산제, 항천식제/기관지 진경약, 항생제, 향정신제, 항당뇨병제, 항알러지제/항히스타민제, 항저혈압제, 진해제, 완하제, 점액용해제/거담약, H2 블록제, 국소 마취제, 구토방지제/프로키네틱제, 지방 저하제, 편두통에 효과적인 제제, 교감 신경 흥분제, 비타민 및 미네랄로 구성되는 군에서 선택되는 방법.
- 제1항에 있어서, 용융 온도가 30 내지 200 ℃인 방법.
- 제1항에 있어서, 용융 온도가 40 내지 160 ℃인 방법.
- A. (i) CO2공여체 및(ii) 산성 성분을 함유하는 발포 조성물,B. 제약 활성 물질, 및C. 보조 물질로 구성되고, 보조 물질 C는 가융성 당 및(또는) 당 알콜 및(또는) 당 대용물을 함유하며, 성분 A(i) 및(또는) A(ii)는 가융성 당 및(또는) 당 알콜 및(또는) 당 대용물의 매트릭스 내에 분산되어 있는 것을 특징으로 하는 발포 제제.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19822036A DE19822036A1 (de) | 1998-05-15 | 1998-05-15 | Brausezubereitungen |
| DE19822036.7 | 1998-05-15 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| KR20010043600A true KR20010043600A (ko) | 2001-05-25 |
| KR100629817B1 KR100629817B1 (ko) | 2006-09-29 |
Family
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020007012745A KR100629817B1 (ko) | 1998-05-15 | 1999-05-03 | 발포 제제 |
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| Country | Link |
|---|---|
| EP (1) | EP1077684B1 (ko) |
| JP (1) | JP4452403B2 (ko) |
| KR (1) | KR100629817B1 (ko) |
| AR (1) | AR016473A1 (ko) |
| AT (1) | ATE246494T1 (ko) |
| AU (1) | AU3929799A (ko) |
| BR (1) | BR9910454A (ko) |
| CA (1) | CA2331671C (ko) |
| CO (1) | CO4830457A1 (ko) |
| CZ (1) | CZ300778B6 (ko) |
| DE (2) | DE19822036A1 (ko) |
| DK (1) | DK1077684T3 (ko) |
| EE (1) | EE04701B1 (ko) |
| ES (1) | ES2203134T3 (ko) |
| GT (1) | GT199900062A (ko) |
| HN (1) | HN1999000067A (ko) |
| HR (1) | HRP20000781B1 (ko) |
| HU (1) | HU224034B1 (ko) |
| ID (1) | ID27441A (ko) |
| IL (1) | IL139240A (ko) |
| NO (1) | NO20005722L (ko) |
| PA (1) | PA8472001A1 (ko) |
| PE (1) | PE20000465A1 (ko) |
| PL (1) | PL194347B1 (ko) |
| PT (1) | PT1077684E (ko) |
| SI (1) | SI1077684T1 (ko) |
| SK (1) | SK284621B6 (ko) |
| TR (1) | TR200003357T2 (ko) |
| UY (1) | UY25510A1 (ko) |
| WO (1) | WO1999059553A1 (ko) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6649186B1 (en) * | 1996-09-20 | 2003-11-18 | Ethypharm | Effervescent granules and methods for their preparation |
| EP1150660B1 (de) * | 1999-02-11 | 2004-01-21 | Hexal Ag | Pharmazeutische, metamizol enthaltende brauseformulierung |
| FR2823668B1 (fr) * | 2001-04-20 | 2004-02-27 | Ethypharm Lab Prod Ethiques | Comprimes effervescents orodispersibles |
| WO2006082499A1 (en) * | 2005-02-03 | 2006-08-10 | Nycomed Pharma As | Melt granulation of a composition containing a calcium-containing compound |
| GR1007299B (el) * | 2010-03-24 | 2011-06-06 | Uni - Pharma Κλεων Τσετης Φαρμακευτικα Εργαστηρια Αβεε Με Δ.Τ. Uni-Pharma Αβεε, | Πρωτοτυπη αναβραζουσα φαρμακευτικη συνθεση υδροχλωρικης μετφορμινης με τη μορφη δισκιου |
| WO2013022410A2 (en) | 2011-08-08 | 2013-02-14 | Mahmut Bilgic | Production method for effervescent formulations comprising dexketoprofen |
| EP3193843A1 (en) | 2014-09-17 | 2017-07-26 | Steerlife India Private Limited | Effervescent composition and method of making it |
| US11559483B2 (en) * | 2015-07-10 | 2023-01-24 | Sanjay Gupta | Nasal foam via cribriform plate for medication delivery to the brain and/or body and for nasal moisturization and hygiene |
| WO2017098481A1 (en) * | 2015-12-12 | 2017-06-15 | Steerlife India Private Limited | Effervescent compositions of metformin and processes for preparation thereof |
| JP2018183067A (ja) * | 2017-04-24 | 2018-11-22 | 株式会社松原製餡所 | 発泡性添加物、及び、餡食品 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4004036A (en) * | 1966-05-31 | 1977-01-18 | Alberto Culver Company | Effervescent molded triturate tablets |
| US3653914A (en) * | 1970-03-20 | 1972-04-04 | Alberto Culver Co | Production of tablets |
| DE69102900T3 (de) * | 1990-02-14 | 1998-04-09 | Otsuka Pharma Co Ltd | Brausemischung, deren Herstellung sowie Verwendung. |
| RU2096955C1 (ru) * | 1991-03-01 | 1997-11-27 | Е.И.Дюпон Де Немур Энд Компани | Вододиспергируемая гранулированная пестицидная композиция, получаемая методом экструзии, и способ ее получения |
| MX9300110A (es) * | 1992-01-13 | 1994-07-29 | Gerhard Gergely | Preparacion farmaceutica en la forma de una tableta de efervescencia o de desintegracion o de un granulado de tipo instanteneo y procedimiento para su preparacion. |
| HU217125B (hu) * | 1993-03-10 | 1999-11-29 | Béres Rt. | Cukor- és nátriummentes pezsgőtabletta és -granulátum és eljárás azok előállítására |
| AU677432B2 (en) * | 1993-09-09 | 1997-04-24 | Gerhard Gergely | Effervescent granulated material and method for its preparation |
| GB2307857B (en) * | 1995-12-04 | 1999-01-27 | Euro Celtique Sa | An effervescent formulation |
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1998
- 1998-05-15 DE DE19822036A patent/DE19822036A1/de not_active Withdrawn
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