JP2017538733A - 医薬送達システムの製造方法 - Google Patents
医薬送達システムの製造方法 Download PDFInfo
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- JP2017538733A JP2017538733A JP2017532816A JP2017532816A JP2017538733A JP 2017538733 A JP2017538733 A JP 2017538733A JP 2017532816 A JP2017532816 A JP 2017532816A JP 2017532816 A JP2017532816 A JP 2017532816A JP 2017538733 A JP2017538733 A JP 2017538733A
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- Prior art keywords
- calcium carbonate
- delivery system
- pharmaceutical delivery
- acid
- eur
- Prior art date
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- 238000000034 method Methods 0.000 title claims abstract description 87
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 17
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims abstract description 331
- 229910000019 calcium carbonate Inorganic materials 0.000 claims abstract description 127
- 238000012377 drug delivery Methods 0.000 claims abstract description 25
- 239000000203 mixture Substances 0.000 claims description 130
- 238000007906 compression Methods 0.000 claims description 96
- 230000006835 compression Effects 0.000 claims description 96
- 239000002253 acid Substances 0.000 claims description 93
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 claims description 86
- 239000013543 active substance Substances 0.000 claims description 72
- 239000003826 tablet Substances 0.000 claims description 72
- 239000002245 particle Substances 0.000 claims description 63
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- 239000002243 precursor Substances 0.000 claims description 57
- 229940088417 precipitated calcium carbonate Drugs 0.000 claims description 53
- 239000001569 carbon dioxide Substances 0.000 claims description 43
- 229910002092 carbon dioxide Inorganic materials 0.000 claims description 43
- 238000009472 formulation Methods 0.000 claims description 36
- 239000011148 porous material Substances 0.000 claims description 36
- 238000009490 roller compaction Methods 0.000 claims description 29
- 238000007873 sieving Methods 0.000 claims description 23
- FGUUSXIOTUKUDN-IBGZPJMESA-N C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 Chemical compound C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 FGUUSXIOTUKUDN-IBGZPJMESA-N 0.000 claims description 21
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- 150000007513 acids Chemical class 0.000 claims description 15
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- 229910052500 inorganic mineral Inorganic materials 0.000 claims description 15
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- QSHDDOUJBYECFT-UHFFFAOYSA-N mercury Chemical compound [Hg] QSHDDOUJBYECFT-UHFFFAOYSA-N 0.000 claims description 14
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- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 11
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- 101100456957 Arabidopsis thaliana MEX1 gene Proteins 0.000 description 10
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 10
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- 235000011180 diphosphates Nutrition 0.000 description 8
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- OROGSEYTTFOCAN-UHFFFAOYSA-N hydrocodone Natural products C1C(N(CCC234)C)C2C=CC(O)C3OC2=C4C1=CC=C2OC OROGSEYTTFOCAN-UHFFFAOYSA-N 0.000 description 8
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 description 8
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- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 7
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- BCEHBSKCWLPMDN-MGPLVRAMSA-N voriconazole Chemical compound C1([C@H](C)[C@](O)(CN2N=CN=C2)C=2C(=CC(F)=CC=2)F)=NC=NC=C1F BCEHBSKCWLPMDN-MGPLVRAMSA-N 0.000 description 1
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- 230000002087 whitening effect Effects 0.000 description 1
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- 229940074158 xanax Drugs 0.000 description 1
- 235000008210 xanthophylls Nutrition 0.000 description 1
- 150000003735 xanthophylls Chemical class 0.000 description 1
- 229940072358 xylocaine Drugs 0.000 description 1
- 229960000317 yohimbine Drugs 0.000 description 1
- BLGXFZZNTVWLAY-SCYLSFHTSA-N yohimbine Chemical compound C1=CC=C2C(CCN3C[C@@H]4CC[C@H](O)[C@@H]([C@H]4C[C@H]33)C(=O)OC)=C3NC2=C1 BLGXFZZNTVWLAY-SCYLSFHTSA-N 0.000 description 1
- AADVZSXPNRLYLV-UHFFFAOYSA-N yohimbine carboxylic acid Natural products C1=CC=C2C(CCN3CC4CCC(C(C4CC33)C(O)=O)O)=C3NC2=C1 AADVZSXPNRLYLV-UHFFFAOYSA-N 0.000 description 1
- 235000010930 zeaxanthin Nutrition 0.000 description 1
- 239000001775 zeaxanthin Substances 0.000 description 1
- 229940043269 zeaxanthin Drugs 0.000 description 1
- 239000011746 zinc citrate Substances 0.000 description 1
- 235000006076 zinc citrate Nutrition 0.000 description 1
- 229940068475 zinc citrate Drugs 0.000 description 1
- 229940085658 zinc citrate trihydrate Drugs 0.000 description 1
- 229960001360 zolmitriptan Drugs 0.000 description 1
- ULSDMUVEXKOYBU-ZDUSSCGKSA-N zolmitriptan Chemical compound C1=C2C(CCN(C)C)=CNC2=CC=C1C[C@H]1COC(=O)N1 ULSDMUVEXKOYBU-ZDUSSCGKSA-N 0.000 description 1
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Abstract
Description
a) 天然の重質または沈降炭酸カルシウムと、二酸化炭素および1つ以上の酸との水性媒体中での反応生成物である表面反応炭酸カルシウムを提供する工程であって、二酸化炭素が酸処理によってその場で形成される、および/または外部供給源から供給される工程;
b) 少なくとも1つの薬学的に活性な薬剤またはその薬学的に不活性な前駆体を提供する工程;
c) 少なくとも1つの配合助剤を提供する工程;
d) 工程a)の表面反応炭酸カルシウム、工程b)の少なくとも1つの薬学的に活性な薬剤またはその薬学的に不活性な前駆体および工程c)の少なくとも1つの配合助剤を混合する工程;および
e) 工程d)で得られた混合物をローラー圧縮機により4から20バールの範囲の圧縮圧力で圧縮する工程;および
f) 医薬送達システムを得るために工程e)で得られたローラー圧縮された混合物を圧縮する工程
を含む。
(FRRCPh)/(FRRCPl)≧1.2 (I)
[式中、
(FRRCPh)は、医薬送達システムRCPhの、Ph.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力が少なくとも15バールであり、
(FRRCPl)は、医薬送達システムRCPlの、Ph.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力が、医薬送達システムRCPhを得るために使用される圧縮圧力よりも低い]を満たす使用が提供される。
(FLRCP)/(FLreference)≧1.1 (II)
[式中、
(FLRCP)は、医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)であり、
(FLreference)は、表面反応炭酸カルシウムが微結晶性セルロースで置き換えられている同じ医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)である]を満たす使用が提供される。
a) 天然の重質または沈降炭酸カルシウムと、二酸化炭素および1つ以上の酸との水性媒体中での反応生成物である表面反応炭酸カルシウムを提供する工程であって、二酸化炭素が酸処理によってその場で形成される、および/または外部供給源から供給される工程;
b) いかなるバインダーおよび/または加工助剤をも用いずに、工程a)の表面反応炭酸カルシウムを、ローラー圧縮機を用いて、4から20バールの圧縮圧力で圧縮してローラー圧縮材料を得る工程;および
c) 場合により、錠剤、ミニ錠剤、カプセル、ペレットまたは顆粒を含む医薬送達システムを得るために、工程b)で得られたローラー圧縮材料を転化する工程
を含む。
(FRRCPh)/(FRRCPl)≧1.2 (I)
[式中、
(FRRCPh)は、医薬送達システムRCPhの、Ph.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力が少なくとも15バールであり、
(FRRCPl)は、医薬送達システムRCPlの、Ph.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力が、医薬送達システムRCPhを得るために使用される圧縮圧力よりも低い]
を満たす。
(FLRCP)/(FLreference)≧1.1 (II)
[式中、
(FLRCP)は、医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)であり、
(FLreference)は、表面反応炭酸カルシウムが微結晶性セルロースで置き換えられている同じ医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)である]
を満たす。
a) 天然の重質または沈降炭酸カルシウムの懸濁液を提供する工程、
b) 20℃で0以下のpKa値を有するまたは20℃で0から2.5のpKa値を有する少なくとも1つの酸を工程a)の懸濁液に添加する工程、および
c) 工程b)の前、最中または後に、工程a)の懸濁液を二酸化炭素で処理する工程。
A) 天然の重質または沈降炭酸カルシウムを提供する工程、
B) 少なくとも1つの水溶性の酸を提供する工程、
C) ガス状のCO2を供給する工程、
D) 工程A)の前記天然の重質または沈降炭酸カルシウムを工程B)の少なくとも1つの酸および工程C)のCO2と接触させる工程、
を含み、
i) 工程B)の少なくとも1つの酸が、その第1の利用可能な水素のイオン化に関連して、20℃で2.5より大きく7以下のpKa値を有し、この第1の利用可能な水素の損失時に、水溶性のカルシウム塩を形成することができる対応のアニオンが形成され、および
ii) 少なくとも1つの酸を天然の重質または沈降炭酸カルシウムと接触させた後、水素含有塩の場合には、第1の利用可能な水素のイオン化に関連して20℃で7より大きいpKaを有し、その塩アニオンは水不溶性のカルシウム塩を形成することができる少なくとも1つの水溶性の塩がさらに添加される
ことを特徴とする方法によって得られる。
(FRRCPh)/(FRRCPl)≧1.2 (I)
式中、
(FRRCPh)は、医薬送達システムRCPhのPh.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力は少なくとも15バールであり、
(FRRCPl)は、医薬送達システムRCPlのPh.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力は、医薬送達システムRCPhを得るために使用される圧縮圧力よりも低い。
(FRRCPh)/(FRRCPl)≧1.5 (Ia)
(FRRCPh)/(FRRCPl)≧1.7 (Ib)
2.5≧(FRRCPh)/(FRRCPl)≧1.7 (Ic)
式中、
(FRRCPh)は、医薬送達システムRCPhのPh.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力は少なくとも15バールであり、
(FRRCPl)は、医薬送達システムRCPlのPh.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力は、医薬送達システムRCPhを得るために使用される圧縮圧力よりも低い。
(FLRCP)/(FLreference)≧1.1 (II)
式中、
(FLRCP)は、医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)であり、
(FLreference)は、表面反応炭酸カルシウムが微結晶性セルロースで置き換えられている同じ医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)である。
2.0≧(FLRCP)/(FLreference)≧1.1 (IIa)
1.8≧(FLRCP)/(FLreference)≧1.1 (IIb)
1.5≧(FLRCP)/(FLreference)≧1.1 (IIc)
式中、
(FLRCP)は、医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)であり、
(FLreference)は、表面反応炭酸カルシウムが微結晶性セルロースで置き換えられている同じ医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)である。
a) 100MPaで圧縮した錠剤についてPh.Eur.4に従って測定された、≦1.10%の摩損度を有する、および/または
b) 式(II)
(FRRCPh)/(FRRCPl)≧1.2 (I)
[式中、
(FRRCPh)は、医薬送達システムRCPhのPh.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力は少なくとも15バールであり、
(FRRCPl)は、医薬送達システムRCPlのPh.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力は、医薬送達システムRCPhを得るために使用される圧縮圧力よりも低い。]を満たす。
(FRRCPh)/(FRRCPl)≧1.5 (Ia)
(FRRCPh)/(FRRCPl)≧1.7 (Ib)
2.5≧(FRRCPh)/(FRRCPl)≧1.7 (Ic)
式中、
(FRRCPh)は、医薬送達システムRCPhのPh.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力は少なくとも15バールであり、
(FRRCPl)は、医薬送達システムRCPlのPh.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力は、医薬送達システムRCPhを得るために使用される圧縮圧力よりも低い。
(FLRCP)/(FLreference)≧1.1 (II)
[式中、
(FLRCP)は、医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)であり、
(FLreference)は、表面反応炭酸カルシウムが微結晶性セルロースで置き換えられている同じ医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)である。]を満たす。
2.0≧(FLRCP)/(FLreference)≧1.1 (IIa)
1.8≧(FLRCP)/(FLreference)≧1.1 (IIb)
1.5≧(FLRCP)/(FLreference)≧1.1 (IIc)
式中、
(FLRCP)は、医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)であり、
(FLreference)は、表面反応炭酸カルシウムが微結晶性セルロースで置き換えられている同じ医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)である。
1.1 材料
官能化された炭酸カルシウム(FCC)(スイスのOmya International AGから)を、微結晶性セルロース(Avicel(R) PH102、FMC BioPolymer、アイルランド)と比較した。官能化された炭酸カルシウムの更なる詳細は、以下の表1に要約されている。
1.2.1 ローラー圧縮および粉砕
ローラー圧縮の前に、各粉末を1000μmのふるいにかけ、凝集体を破壊した。賦形剤をパラセタモールと混合して、24.75%(w/w)、49.50%(w/w)、74.25%(w/w)および99%(w/w)の相対パラセタモール含量を得た。さらに、パラセタモールを含まない参照製剤を調製した。比較のために、全ての製剤は、1重量%のフマル酸ステアリルナトリウムを内部潤滑剤として含有した。粉末を32rpmで回転筒ミキサー(Turbula T2C、Willy A.Bachofen AG、スイス)中で10分間混合した。顆粒化は、Fitzpatrick(R) Chilsonator IR220ローラー圧縮機(The Fitzpatrick Company、米国)を用いて行った。圧力は5バールまたは20バールのいずれかに設定した。リボンの厚さが0.6mmになるように送り速度とロール速度を調整した。ローラー圧縮後、リボンをFitzMill(R) L1A(The Fitzpatrick Company、米国)を用いて500rpmで粉砕した。
ふるい分けを行った。各製剤について、それぞれのリボン10gを500μmのメッシュサイズのふるい上に置いた。振動ふるい塔(Vibro Retsch、スイス)を用いて、ふるいを1.5mmの振盪変位で10分間振盪した。残留割合(RF)は、以下の式を用いて計算した。
ローラー圧縮処理で得られた微粉割合を決定するために、ローラー圧縮処理(微粉を含むリボン)の生成物を集め、秤量し(mtot)、180μmのメッシュサイズのふるいでふるい分けた。ふるい分けは、ローラー圧縮処理から得られた対応する生成物を180μmメッシュサイズのふるい上に置くことで行った。振動ふるい塔(Vibro Retsch、スイス)を用いて、ふるいを1.5mmの振盪変位で10分間振盪した。
錠剤の調製には、180μmから710μmの間のサイズを有する全ての顆粒を使用した。この顆粒を、回転筒ミキサー(Turbula T2C、Willy A.Bachofen AG、スイス)中で32rpmで10分間混合する前に、KVTS11型(Salvis、スイス)の真空乾燥キャビネット中で窒素流下に一晩(12から15時間)乾燥させた。顆粒を、Styl’One 105ml錠剤プレス(Medel’Pharm、フランス)を使用して、10mmの丸い平らな工具で圧縮した。錠剤プレスは、Analisソフトウェアバージョン2.01(Medel’Pharm、フランス)を備えていた。圧縮中、原料の非常に変化しやすい多孔度のために、錠剤の体積を最低の圧縮圧力で一定に保った。圧縮圧力6.37MPa(0.50kN)で6mmの錠剤高さを得るために、パンチ隙間を各製剤について調整した。各製剤の圧縮圧力範囲全体にわたってパンチ間隙を一定に保った。この製剤を、6MPaから500MPaの範囲の10種類の異なる圧縮圧力で3回圧縮した。積層が500MPa未満で生じた場合、圧縮圧力のさらなる増加を停止させた。パンチおよびダイを、ステアリン酸マグネシウムで手動で潤滑させた。下側パンチの上昇および下降を750msに設定し、「維持」段階を0msに設定することによって、錠剤を可能な最小滞留時間で圧縮した。
錠剤の圧縮直後に、錠剤重量、寸法、高さ、および破砕力を3回測定した。重量は、Delta Range AX204天秤(Mettler Toledo、スイス)を用いて測定した。直径および高さは、タイプCD−15CPX(Mitutoyo、日本)のマイクロメータースクリューを用いて測定した。衝撃速度1mm/秒で錠剤硬度試験機(8M、Schleuniger Pharmatron、スイス)を用いて400N未満の破砕力を測定した。Stirnimann Tら、薬学の国際ジャーナル、2014年5月15日、466(1−2):266−75「Compaction of functionalized calcium carbonate, a porous and crystalline microparticulate material with a lamellar surface」に記載されているように、より硬い錠剤(>400N)はStyl’One錠剤プレス(Medel’Pharm、フランス)で試験した。
ソフトウェアOriginProバージョン8.5(OriginLab Corporation、米国)を用いて、ヘッケル式(Heckel RW、Density−pressure relationships in powder compaction. Trans Metall Soc AIME. 1961;221:671−5およびHeckel RW. An analysis of powder compaction phenomena. Trans Metall Soc AIME. 1961;221:1001−8)を以下の式に従って適合させた。
細孔径分布を測定するために、1.2.4節に記載されているように錠剤を調製した。分析は、Auto Pore IV 9500水銀ポロシメーター(Micromeritics、米国)を用いて行った。低圧および高圧水銀圧入は、それぞれ3.59kPaから206.64kPaおよび206.78kPaから206.78MPaの範囲であった。平衡時間は全圧力範囲にわたって10秒に設定した。
2.1 ふるい分け
打錠のために、顆粒は、好ましくは、さらなる処理のために一定の剛性を示すべきである。微粉画分(<500μm)は、リボンの剛性にヒントを与える。18種の製剤を用いたふるい分けは、60%(w/w)を超える残留割合(>500μm)を示したので、関心のある10種の製剤をもたらした。これは、固形物の40%(リボンの形態で)のみが、10分間振盪した後、500μm未満のサイズの微粉に崩壊したことを意味する。
表2は、調製された製剤のローラー圧縮中の微粉割合を示す。ローラー圧縮中の圧縮圧力を5バールから20バールに増加させた後、FCC混合物が微粉割合を50%減少させることが示されたことが推測できる。従来技術(アビセル)の微結晶性セルロースと比較可能なように、混合物中のパラセタモールの量を増加させることにより、より高い微粉割合がFCCについて観察された。しかし、74.25%薬物充填での微粉割合は、従来技術の微結晶性セルロース(アビセル)について観察されたものよりもはるかに低かった。
表2は、異なる製剤について得られた錠剤重量を示す。5バールでローラー圧縮された顆粒は、ローラー圧縮中の緻密化が少ないため、20バールでの顆粒よりも軽い錠剤を生じた。20バールで処理されたパラセタモール混合物のうち、FCC−パラセタモール混合物は、従来技術の微結晶セルロースのアビセル(約0.57g/cm3)と比較してより高いFCC嵩密度(約0.64g/cm3)に起因して、同じ薬剤−賦形剤比でアビセル−パラセタモール混合物と比較して重い錠剤を生成した。
図3は、粉末および顆粒で作製したFCC錠剤の細孔径分布の水銀ポロシメトリープロットを示す。錠剤は、3つの異なる圧縮圧力で圧縮された。圧縮圧力を増加させることによって、FCCの高密度化および粒子表面の薄片の崩壊の結果として、特徴的なピークがより小さい細孔直径にシフトした(図3)。同じ圧縮圧力で圧縮された錠剤のプロットは、全ての種類の主要材料(粉末または顆粒)についてほぼ一致していた。唯一の注目すべき違いは、粉末と比較してより大きい細孔直径では顆粒の細孔容積がより高いことである。FCCの粒子内構造(直径が0.02μm未満の細孔)は、ローラー圧縮処理によっても打錠によっても影響されなかった。
FCCのローラー圧縮は、ローラー圧縮中の圧力が低くても、低い微粉割合分で剛直なリボンを示した。得られたFCCおよび薬学的に活性な薬剤から製造された顆粒は、対応する微結晶性セルロース(アビセル)に基づく製剤よりも良好な流動性を示した。さらに、顆粒化FCCおよび薬学的に活性な薬剤から構成された錠剤は、微結晶性セルロース(アビセル)に基づく製剤よりも全圧力範囲にわたって著しく高い引張強度を示した。従って、FCCの顆粒化製剤は、微結晶性セルロース(アビセル)に基づく製剤または非顆粒化FCC製剤と比較して、流動性およびコンパクタビリティに関して優れた特性を有する。
Claims (15)
- 医薬送達システムを製造する方法であって、以下の工程:
a) 天然の重質または沈降炭酸カルシウムと、二酸化炭素および1つ以上の酸との水性媒体中での反応生成物である表面反応炭酸カルシウムを提供する工程であって、二酸化炭素が、酸処理によってその場で形成される、および/または外部供給源から供給される工程;
b) 少なくとも1つの薬学的に活性な薬剤またはその薬学的に不活性な前駆体を提供する工程;
c) 少なくとも1つの配合助剤を提供する工程;
d) 工程a)の表面反応炭酸カルシウム、工程b)の少なくとも1つの薬学的に活性な薬剤またはその薬学的に不活性な前駆体および工程c)の少なくとも1つの配合助剤を混合する工程;および
e) 工程d)で得られた混合物をローラー圧縮機により4から20バールの範囲の圧縮圧力で圧縮する工程;および
f) 医薬送達システムを得るために工程e)で得られたローラー圧縮された混合物を圧縮する工程
を含む方法。 - 天然の重質炭酸カルシウムが、大理石、チョーク、ドロマイト、石灰石およびそれらの混合物を含む群から選択される炭酸カルシウムを含む鉱物から選択されるか;または沈降炭酸カルシウムが、アラゴナイト、バテライトまたはカルサイト鉱物結晶形を有する沈降炭酸カルシウムおよびそれらの混合物を含む群から選択される請求項1に記載の方法。
- 表面反応炭酸カルシウムが、
a) 窒素およびISO9277に従ってBET法を用いて測定される、20.0m2/gから200.0m2/g、好ましくは20.0m2/gから180.0m2/g、より好ましくは30.0m2/gから160.0m2/g、さらにより好ましくは40.0m2/gから150.0m2/g、最も好ましくは50.0m2/gから140.0m2/gのBET比表面積を有する;および/または
b) 2.0から50.0μm、好ましくは2.5から25.0μm、より好ましくは2.8から20.0μm、さらにより好ましくは3.0から10.0μm、最も好ましくは4.0から8.0μmの体積メジアン粒径d50を有する粒子を含む;および/または
c) 水銀圧入ポロシメトリー寸法から計算される、0.15から1.35cm3/g、好ましくは0.30から1.30cm3/g、最も好ましくは0.40から1.25cm3/gの範囲内の粒子内圧入比細孔容積を有する
請求項1または2に記載の方法。 - 少なくとも1つの薬学的に活性な薬剤またはその薬学的に不活性な前駆体が、合成起源、半合成起源、天然起源およびそれらの組み合わせの薬学的に活性な薬剤または薬学的に不活性な前駆体を含む群から選択される請求項1から3のいずれか一項に記載の方法。
- 少なくとも1つの配合助剤が、
a) 少なくとも1つの内相潤滑剤および/または外相潤滑剤であり;および/または
b) 医薬送達システムの総重量に基づいて約0.1重量%から約10.0重量%、好ましくは約0.3重量%から約5.0重量%、より好ましくは約0.5重量%から約2.5重量%の総量で提供される請求項1から4のいずれか一項に記載の方法。 - ローラー圧縮工程e)が、4から15バールの範囲、より好ましくは4から10バールの範囲、最も好ましくは4から7バールの範囲のローラー圧縮圧力で行われる請求項1から5のいずれか一項に記載の方法。
- 圧縮工程f)が、ペレット化または打錠工程である請求項1から6のいずれか一項に記載の方法。
- ローラー圧縮工程e)で得られたローラー圧縮混合物が、圧縮工程f)が実施される前に粉砕工程に付される請求項1から7のいずれか一項に記載の方法。
- ローラー圧縮混合物が、異なる複数のメッシュサイズで、好ましくは180μm、250μm、355μm、500μmおよび710μmのメッシュサイズで、ふるい分けることによって得られる180μmから710μmの粒径を有する請求項1から8のいずれか一項に記載の方法。
- 医薬送達システムが、
a) 100MPaで圧縮された錠剤についてPh.Eur.4に従って測定された、≦1.10%の摩損度を有する;および/または
b)式(I)
(FRRCPh)/(FRRCPl)≧1.2 (I)
[式中、
(FRRCPh)は、医薬送達システムRCPhの、Ph.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力が少なくとも15バールであり、
(FRRCPl)は、医薬送達システムRCPlの、Ph.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力が、医薬送達システムRCPhを得るために使用される圧縮圧力よりも低い]を満たす請求項1から9のいずれか一項に記載の方法。 - 医薬送達システムが、式(II)
(FLRCP)/(FLreference)≧1.1 (II)
[式中、
(FLRCP)は、医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)であり、
(FLreference)は、表面反応炭酸カルシウムが微結晶性セルロースで置き換えられている同じ医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)である]を満たす請求項1から10のいずれか一項に記載の方法。 - 医薬送達システムが、錠剤、ミニ錠剤、カプセルまたはペレットである請求項1から11のいずれか一項に記載の方法。
- 医薬送達システムの摩損度を改善するための表面反応炭酸カルシウムの使用であって、表面反応炭酸カルシウムが、天然の重質または沈降炭酸カルシウムと、二酸化炭素および1つ以上の酸との水性媒体中での反応生成物であり、二酸化炭素が、酸処理によってその場で形成され、および/または外部供給源から供給され、医薬送達システムが、
a) 100MPaで圧縮された錠剤についてPh.Eur.4に従って測定された、≦1.10%の摩損度を有する;および/または
b) 式(II)
(FRRCPh)/(FRRCPl)≧1.2 (I)
[式中、
(FRRCPh)は、医薬送達システムRCPhの、Ph.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力が少なくとも15バールであり、
(FRRCPl)は、医薬送達システムRCPlの、Ph.Eur.4に従って測定された摩損度(%で表される)であり、ここで、工程e)における圧縮圧力が、医薬送達システムRCPhを得るために使用される圧縮圧力よりも低い]を満たす使用。 - 医薬送達システムの流動性を改善するための表面反応炭酸カルシウムの使用であって、表面反応炭酸カルシウムが、天然の重質または沈降炭酸カルシウムと、二酸化炭素および1つ以上の酸との水性媒体中での反応生成物であり、二酸化炭素が、酸処理によってその場で形成され、および/または外部供給源から供給され、医薬送達システムが、式(II)
(FLRCP)/(FLreference)≧1.1 (II)
[式中、
(FLRCP)は、医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)であり、
(FLreference)は、表面反応炭酸カルシウムが微結晶性セルロースで置き換えられている同じ医薬送達システムの、開口径7mmでのPh.Eur.4に従って測定された流動性(g/秒で表される)である]を満たす使用。 - 請求項1から12のいずれか一項に記載の方法により得られた医薬送達システム、好ましくは錠剤、ミニ錠剤、カプセルまたはペレット。
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- 2015-12-16 EP EP15813352.0A patent/EP3233062A1/en not_active Withdrawn
- 2015-12-16 CN CN201580069007.1A patent/CN107106498A/zh active Pending
- 2015-12-16 BR BR112017012665A patent/BR112017012665A2/pt not_active IP Right Cessation
- 2015-12-16 SG SG11201704513VA patent/SG11201704513VA/en unknown
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- 2015-12-16 AU AU2015367524A patent/AU2015367524B2/en not_active Ceased
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AU2015367524B2 (en) | 2018-03-15 |
RU2693491C2 (ru) | 2019-07-03 |
RU2017125320A (ru) | 2019-01-18 |
UY36444A (es) | 2016-04-29 |
WO2016096997A1 (en) | 2016-06-23 |
RU2017125320A3 (ja) | 2019-01-18 |
MX2017007880A (es) | 2017-09-05 |
SG11201704513VA (en) | 2017-07-28 |
TW201627009A (zh) | 2016-08-01 |
AU2015367524A1 (en) | 2017-07-20 |
US20190022012A1 (en) | 2019-01-24 |
CO2017005500A2 (es) | 2017-09-29 |
CA2969763A1 (en) | 2016-06-23 |
AR103077A1 (es) | 2017-04-12 |
PH12017501035A1 (en) | 2018-03-05 |
CR20170236A (es) | 2017-09-26 |
CN107106498A (zh) | 2017-08-29 |
KR20170098894A (ko) | 2017-08-30 |
BR112017012665A2 (pt) | 2017-12-26 |
EP3034070A1 (en) | 2016-06-22 |
EP3233062A1 (en) | 2017-10-25 |
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