TW561058B - Pharmaceutical preparation - Google Patents
Pharmaceutical preparation Download PDFInfo
- Publication number
- TW561058B TW561058B TW088107870A TW88107870A TW561058B TW 561058 B TW561058 B TW 561058B TW 088107870 A TW088107870 A TW 088107870A TW 88107870 A TW88107870 A TW 88107870A TW 561058 B TW561058 B TW 561058B
- Authority
- TW
- Taiwan
- Prior art keywords
- sodium
- patent application
- scope
- levothyroxine
- item
- Prior art date
Links
- 239000000825 pharmaceutical preparation Substances 0.000 title claims abstract description 11
- XUIIKFGFIJCVMT-LBPRGKRZSA-N L-thyroxine Chemical compound IC1=CC(C[C@H]([NH3+])C([O-])=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 XUIIKFGFIJCVMT-LBPRGKRZSA-N 0.000 claims abstract description 15
- 229960003918 levothyroxine sodium Drugs 0.000 claims abstract description 13
- 239000000945 filler Substances 0.000 claims abstract description 9
- 229920000159 gelatin Polymers 0.000 claims abstract description 7
- 235000019322 gelatine Nutrition 0.000 claims abstract description 7
- 238000000034 method Methods 0.000 claims abstract description 5
- 239000003960 organic solvent Substances 0.000 claims abstract description 5
- 238000002360 preparation method Methods 0.000 claims description 13
- 239000000203 mixture Substances 0.000 claims description 8
- XUIIKFGFIJCVMT-UHFFFAOYSA-N thyroxine-binding globulin Natural products IC1=CC(CC([NH3+])C([O-])=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 XUIIKFGFIJCVMT-UHFFFAOYSA-N 0.000 claims description 8
- 108010010803 Gelatin Proteins 0.000 claims description 6
- 239000008273 gelatin Substances 0.000 claims description 6
- 235000011852 gelatine desserts Nutrition 0.000 claims description 6
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 6
- 229950008325 levothyroxine Drugs 0.000 claims description 6
- YDTFRJLNMPSCFM-YDALLXLXSA-M levothyroxine sodium anhydrous Chemical compound [Na+].IC1=CC(C[C@H](N)C([O-])=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 YDTFRJLNMPSCFM-YDALLXLXSA-M 0.000 claims description 5
- 229920002261 Corn starch Polymers 0.000 claims description 4
- 239000008120 corn starch Substances 0.000 claims description 4
- 239000008101 lactose Substances 0.000 claims description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 3
- 239000003795 chemical substances by application Substances 0.000 claims description 3
- SBXXSUDPJJJJLC-YDALLXLXSA-M liothyronine sodium Chemical compound [Na+].IC1=CC(C[C@H](N)C([O-])=O)=CC(I)=C1OC1=CC=C(O)C(I)=C1 SBXXSUDPJJJJLC-YDALLXLXSA-M 0.000 claims description 3
- 239000000314 lubricant Substances 0.000 claims description 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 3
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 3
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 3
- 239000002245 particle Substances 0.000 claims description 3
- 239000007787 solid Substances 0.000 claims description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 229910000831 Steel Inorganic materials 0.000 claims 1
- GFZPUGCMGGUPHH-UHFFFAOYSA-N [I].[Na] Chemical compound [I].[Na] GFZPUGCMGGUPHH-UHFFFAOYSA-N 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- 239000007767 bonding agent Substances 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 238000009477 fluid bed granulation Methods 0.000 claims 1
- 239000007937 lozenge Substances 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 239000010959 steel Substances 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
- 239000001828 Gelatine Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 150000001875 compounds Chemical class 0.000 description 8
- 238000009472 formulation Methods 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- XUIIKFGFIJCVMT-GFCCVEGCSA-N D-thyroxine Chemical compound IC1=CC(C[C@@H](N)C(O)=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 XUIIKFGFIJCVMT-GFCCVEGCSA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- NLKNQRATVPKPDG-UHFFFAOYSA-M potassium iodide Chemical compound [K+].[I-] NLKNQRATVPKPDG-UHFFFAOYSA-M 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 229940034208 thyroxine Drugs 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 2
- AUYYCJSJGJYCDS-LBPRGKRZSA-N Thyrolar Chemical class IC1=CC(C[C@H](N)C(O)=O)=CC(I)=C1OC1=CC=C(O)C(I)=C1 AUYYCJSJGJYCDS-LBPRGKRZSA-N 0.000 description 2
- 239000011230 binding agent Substances 0.000 description 2
- 230000002079 cooperative effect Effects 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 229920000609 methyl cellulose Polymers 0.000 description 2
- 239000001923 methylcellulose Substances 0.000 description 2
- 235000010981 methylcellulose Nutrition 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 229940036555 thyroid hormone Drugs 0.000 description 2
- 239000005495 thyroid hormone Substances 0.000 description 2
- 229920000858 Cyclodextrin Polymers 0.000 description 1
- 239000004471 Glycine Substances 0.000 description 1
- 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 1
- 239000000654 additive Substances 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 239000006227 byproduct Substances 0.000 description 1
- 235000014633 carbohydrates Nutrition 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000002105 nanoparticle Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 239000008055 phosphate buffer solution Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- DHCDFWKWKRSZHF-UHFFFAOYSA-N sulfurothioic S-acid Chemical compound OS(O)(=O)=S DHCDFWKWKRSZHF-UHFFFAOYSA-N 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2063—Proteins, e.g. gelatin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
- A61P5/16—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4 for decreasing, blocking or antagonising the activity of the thyroid hormones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Description
561058 A7 經濟部智慧財產局員工消費合作社印製 -----^___B7_______——五、發明說明（1 ) 本發明係關於一種新穎穩定之醫藥製劑，包括左旋甲狀 腺素鈉、明膠及充填劑，且不含有機溶劑殘餘物。 此新穎之製劑具有改良之穩定性，且可用於甲狀腺激素 製劑。 此新穎之製劑進一步具有改良之活體外活性化合物釋放 性。 本發明係基於製備可得之新穎藥劑以醫藥製劑之型式， 其具有較用於相同目的的習知藥劑較佳的性質。 在一九九七年八月十四日美國藥物食品管理局出版的 Federal Register第62卷第15期第43535頁中，指出在 美國市場販售包含左旋甲狀腺鈉經口服投藥的產品，具有 穩定性的問題，需存在高至2 0 %過多劑量於產品中，因此 製造商須發展適當的新穎投藥劑型。而左旋甲狀腺鈉在活 體内釋放的需求則進一步地增加。Pharmacopeial Forum 單行版（pharm. Preview, 1995，21，1 4 5 9-1 4 6 1 )建議，除了有效的試驗丨（磷酸緩衝液ρ Η 7.4，在8 0 分鐘内大於5 5 % )，亦需證實試驗2 (水在4 5分鐘大於 7 0%) 〇 此目的現藉由此新穎醫藥製劑之發現達成。 含甲狀腺素製劑與其他添加物如甘胺酸、碳水化合物及 無機鹽揭示於W 0 9 7 1 7 9 5 1。另一甲狀腺素製劑以硫代 硫酸鹽穩定者敘述於D E 1 9 5 4 1 1 2 8。 包括左旋甲狀腺素鈉及碘化鉀之組合製劑係自U S 5，6 3 5，2 0 9得知。另一含有甲狀腺素/環狀糊精複合物之 _ 一 4 - 本紙張尺度綱中關家標準（CNS)A4規格（21G X 297公爱) ' (請先·閱讀背面之注意事項
.- 線· 561058 A7
五、發明說明（2 ) 經濟部智慧財產局員工消費合作社印製 甲狀腺素配方係敘述於W〇 97 19 703。 除了左旋甲狀腺素納，根據本發明之醫藥配方亦可包含 三碘甲狀腺原胺酸鈉。 ° 本發明較佳係關於如所述之醫藥製劑，特徵在於其包含 5至4 0 0微克，較佳為1〇至3〇〇微克，特別是25至3〇〇微 克之左旋甲狀腺素鈉。 本發明進一步係關於如所述之醫藥製劑，特徵係在於其 含有粒徑大小為5微米至2 5微米間之細微化左旋甲狀腺素 納。 本發明進一步係關於如所述之醫藥製劑，特徵係在於其 含有選自包括乳糖及/或玉米澱粉及/或微晶纖維素之群之 充填劑。 一特佳之醫藥製劑係特徵在於其為錠劑型之固體製劑。 特佳之實施態樣含有25、50、75、1〇〇、125、150、 175或200微克之左旋甲狀腺素納。 此（等）活性化合物對光、熱及氧氣敏感。由於此已知之 不穩定性’此活性化合物在配方中含有多達5 0/。的過多劑 量。 根據本發明之製劑，當使用明膠作為結著劑時具有令人 驚訝的穩定度。 若其由另外常用的結著劑如甲基纖維素取代時，即使在 最初的穩定度調查，亦會測到活性化合物含量的下降，再 者’副產物的總量亦會增加。 例如，在1 0 0微克的劑量中，當明膠被換為甲基纖維素 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） (請先閱讀背面之注意事項^||^本頁)
· .線· 561058
、發明說明（ 、’活性化合物的初值經測定會發現為i 0 0 4 8 %而非 1 ο 5 % 〇 穩定度的調查顯示’根據本發明含有左旋甲狀腺素鈉的 錠劑，在低於3 0。(：的溫度下儲存時，可穩定至少2年。 再者，當活性化合物以微化型式使用時，活性化合物左 旋甲狀腺素鈉的釋放係令人驚訝地優異。左旋曱狀腺素鈉 在水或乙醇中通常非常不易溶解，然而在粒徑大小為5微 米土 2 5微米間時（至9 5 % )，活性化合物的釋放在試驗工可 達到大於9 0 % (磷酸緩衝液），在試驗2可達到大於 8 0〇/〇(水）。 令人驚砑地，根據本發明的組合物亦可在不使用有機溶 劑下製備。若用於根據本發明方法的水被換成有機溶劑， 例如甲醇時，將發現試驗批次中左旋甲狀腺素鈉的含量， 在2 5 C的儲存溫度及6 〇 %的相對溼度下經丨年後，下降 1 0 %。 通用於根據本發明的醫藥製劑之充填劑，較佳為乳糖， 玉米澱粉及/或微晶纖維素，前二者可各別作為充填劑並 經濟部智慧財產局員工消費合作社印製 與另一者結合使用。根據所述，特佳的醫藥製劑含有玉米 澱粉及乳糖。 本發明亦關於包括左旋甲狀腺素鈉及視需要三破甲狀腺 原胺酸鈉之醫藥製劑之製備方法，特徵在於左旋甲狀腺素 鈉及視需要三碘甲狀腺原胺酸鈉以懸浮形式存在於在水性 明膠落液中，將此溶液噴至流動床造粒的充填劑上，再與 分解劑及潤滑劑混合，將混合物壓製成錠劑。 ________β _ 本紙張尺度刺巾關家鮮（CNS)A4規格⑵Q χ 297公爱y ----
Claims (1)
- 561058 第088107870號專利申請案 中文申請專利範圍替換本(92年1月）六、申請專利範圍 A8 B8 C8 D8VI1· 一種醫藥製劑，其包括5至400微克之左旋甲狀腺素 鈉、明膠及充填劑，其不含有機溶劑殘餘物° 2 ·根據申請專利範圍第1項之醫藥製劑’特徵在於視需要 包含三碘甲狀腺原胺酸鈉。 3 ·根據申請專利範圍第1項之醫藥製劑，特徵在於包含經 微分化至顆粒大小為5微米至25微米間之左旋甲狀腺素 納0 4 ·根據申請專利範圍第1項之醫藥製劑，特徵在於包含充 填劑係選自由乳糖及/或玉米澱粉及/或微晶纖維素所組 成之群。 5 ·根據申請專利範圍第1或2項之醫藥製劑，特徵在於其為 錠劑形式之固體製劑。 6· —種製備醫藥製劑之方法，特徵在於左旋甲狀腺素鈉及 視需要三碘甲狀腺原胺酸鈉以懸浮形式存在於在水性明 膠溶液中，將此溶液喷至流動床造粒的充填劑上，再與 分解劑及潤滑劑混合，將混合物壓製成包含5至4 0 0微 克左旋甲狀腺素鋼之鍵劑。 7 ·根據申請專利範圍第6項之方法，特徵在於所用之 為分解劑為交聯羧甲基纖維素鈉，所用之潤滑劑為硬脂 酸鎂。 本紙張尺度適用中國國家標準(CNS) A4規格(210 X 297公釐)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19821625A DE19821625C1 (de) | 1998-05-15 | 1998-05-15 | Pharmazeutische Zubereitung |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| TW561058B true TW561058B (en) | 2003-11-11 |
Family
ID=7867752
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW088107870A TW561058B (en) | 1998-05-15 | 1999-05-14 | Pharmaceutical preparation |
Country Status (25)
| Country | Link |
|---|---|
| US (2) | US6646007B1 (zh) |
| EP (1) | EP1077681B1 (zh) |
| JP (1) | JP4709379B2 (zh) |
| CN (1) | CN1145479C (zh) |
| AR (1) | AR018607A1 (zh) |
| AT (1) | ATE225651T1 (zh) |
| AU (1) | AU742382B2 (zh) |
| BR (1) | BRPI9910445B8 (zh) |
| CA (1) | CA2333193A1 (zh) |
| CZ (1) | CZ300908B6 (zh) |
| DE (2) | DE19821625C1 (zh) |
| DK (1) | DK1077681T3 (zh) |
| ES (1) | ES2184452T3 (zh) |
| HU (1) | HU228958B1 (zh) |
| ID (1) | ID27281A (zh) |
| MY (1) | MY120570A (zh) |
| NO (1) | NO331655B1 (zh) |
| PL (1) | PL194088B1 (zh) |
| PT (1) | PT1077681E (zh) |
| RU (1) | RU2225711C2 (zh) |
| SK (1) | SK284155B6 (zh) |
| TW (1) | TW561058B (zh) |
| UA (1) | UA73474C2 (zh) |
| WO (1) | WO1999059551A1 (zh) |
| ZA (1) | ZA200007509B (zh) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI603730B (zh) * | 2012-08-20 | 2017-11-01 | 馬克專利公司 | 含左旋甲狀腺素之固態醫藥製劑 |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6555581B1 (en) | 2001-02-15 | 2003-04-29 | Jones Pharma, Inc. | Levothyroxine compositions and methods |
| US20030224047A1 (en) * | 2001-02-15 | 2003-12-04 | Franz G. Andrew | Levothyroxine compositions and methods |
| ITMI20011401A1 (it) * | 2001-07-02 | 2003-01-02 | Altergon Sa | Formulazioni farmaceutiche per ormoni tiroidei |
| US20030099699A1 (en) * | 2001-11-13 | 2003-05-29 | Hanshew Dwight D. | Storage stable thyroxine active drug formulations and methods for their production |
| US20040152783A1 (en) * | 2002-11-05 | 2004-08-05 | Olon Lawrence Peter | Controlled absorption of admixed thyroid hormone formulations |
| ITMI20022394A1 (it) | 2002-11-13 | 2004-05-14 | Bracco Spa | Uso di triiodotironina 3-solfato come farmaco ad attivita' tireomimetica e relative formulazioni farmaceutiche. |
| ITMI20110713A1 (it) | 2011-04-29 | 2012-10-30 | Bracco Imaging Spa | Processo per la preparazione di un derivato solfatato di3,5-diiodo-o-[3-iodofenil]-l-tirosina |
| GB0316206D0 (en) * | 2003-07-10 | 2003-08-13 | Glaxo Group Ltd | Pharmaceutical formulation |
| ATE390919T1 (de) | 2004-11-18 | 2008-04-15 | Uni Pharma Kleon Tsetis Pharmaceutical Lab Sa | Trockenpulver mit levothyroxin-natrium mit verabreichung über einen inhalator |
| GB0525461D0 (en) * | 2005-12-15 | 2006-01-25 | Archimedes Dev Ltd | Pharmaceutical compositions |
| ITMI20062254A1 (it) * | 2006-11-24 | 2008-05-25 | Acraf | Uso di un acido metossi-alcanoico dell'indazolo per preparare una composizione farmaceutca |
| EP2932963A1 (en) | 2014-04-16 | 2015-10-21 | Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. | Stable pharmaceutical dosage forms comprising Levothyroxine sodium |
| US9682045B2 (en) | 2014-11-21 | 2017-06-20 | Cadila Healthcare Limited | Stable pharmaceutical compositions of thyroid hormone drug |
| US20200046664A1 (en) | 2016-10-10 | 2020-02-13 | Ftf Pharma Private Limited | Method for preparation of liquid oral composition of l-thyroxin |
| CN109010295A (zh) * | 2018-08-29 | 2018-12-18 | 北京兴源联合医药科技有限公司 | 一种左甲状腺素钠冻干口腔崩解片 |
| CN115737576B (zh) * | 2022-11-14 | 2024-05-07 | 山东创新药物研发有限公司 | 一种左甲状腺素钠片剂及其制备方法 |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR6191M (zh) | 1966-02-18 | 1968-07-22 | ||
| US3808332A (en) * | 1969-01-27 | 1974-04-30 | Armour Pharma | Pharmaceutical compositions containing the reaction product of a tertiary phosphine with thyroxine |
| US3621098A (en) | 1969-03-17 | 1971-11-16 | Geigy Chem Corp | HYPOTENSIVE METHODS AND COMPOSITIONS UTILIZING HEXAHYDROBENZO{8 b{9 {0 QUINOLIZINES |
| US3621096A (en) * | 1969-04-03 | 1971-11-16 | Univ North Carolina | Antidepressant method and composition for same comprising a tricyclic antidepressant and a thyroid hormone |
| DE2126533A1 (de) * | 1971-05-28 | 1972-12-14 | Merck Patent Gmbh, 6100 Darmstadt | Verfahren zur Herstellung pharma zeutischer Zubereitungen |
| HUT67319A (en) * | 1991-08-30 | 1995-03-28 | Life Medical Sciences Inc | Compositions for treating wounds |
| US5225204A (en) | 1991-11-05 | 1993-07-06 | Chen Jivn Ren | Stable dosage of levothyroxine sodium and process of production |
| SK279684B6 (sk) * | 1993-06-14 | 1999-02-11 | Janssen Pharmaceutica N.V. | Tableta a spôsob jej výroby |
| GB9325644D0 (en) * | 1993-12-15 | 1994-02-16 | Smithkline Beecham Plc | Novel formulation |
| CA2134611C (en) * | 1994-10-28 | 2002-12-24 | Richard John Yarwood | Process for preparing solid pharmaceutical dosage forms |
| SE9500897D0 (sv) * | 1995-03-14 | 1995-03-14 | Astra Ab | The pharmacological use of certain cystine derivatives |
| CN1126589A (zh) * | 1995-06-09 | 1996-07-17 | 中国科学院成都有机化学研究所 | 一种激素缓释微囊注射剂及其制备方法 |
| DE19541128C2 (de) * | 1995-10-27 | 1997-11-27 | Henning Berlin Gmbh & Co | Stabilisierte schilddrüsenhormonhaltige Arzneimittel |
| CA2235707A1 (en) * | 1995-11-14 | 1997-05-22 | Knoll Pharmaceutical Company | Stabilized thyroid hormone preparations and methods of making same |
| HUT75956A (en) * | 1995-11-29 | 1997-05-28 | Cyclolab | Pharmaceutical composition containing thyroxine |
| US20010039335A1 (en) * | 1997-04-10 | 2001-11-08 | Kenneth Jacobs | Secreted proteins and polynucleotides encoding them |
| FR2772615B1 (fr) * | 1997-12-23 | 2002-06-14 | Lipha | Comprime multicouche pour la liberation instantanee puis prolongee de substances actives |
| DE19830246A1 (de) * | 1998-07-07 | 2000-01-13 | Merck Patent Gmbh | Pharmazeutische Zubereitung |
-
1998
- 1998-05-15 DE DE19821625A patent/DE19821625C1/de not_active Expired - Lifetime
-
1999
- 1999-05-05 BR BRPI9910445A patent/BRPI9910445B8/pt not_active IP Right Cessation
- 1999-05-05 RU RU2000131588/15A patent/RU2225711C2/ru active
- 1999-05-05 CZ CZ20004201A patent/CZ300908B6/cs not_active IP Right Cessation
- 1999-05-05 AT AT99922182T patent/ATE225651T1/de active
- 1999-05-05 WO PCT/EP1999/003087 patent/WO1999059551A1/de active IP Right Grant
- 1999-05-05 PT PT99922182T patent/PT1077681E/pt unknown
- 1999-05-05 JP JP2000549216A patent/JP4709379B2/ja not_active Expired - Lifetime
- 1999-05-05 EP EP99922182A patent/EP1077681B1/de not_active Expired - Lifetime
- 1999-05-05 PL PL99346395A patent/PL194088B1/pl unknown
- 1999-05-05 AU AU39321/99A patent/AU742382B2/en not_active Expired
- 1999-05-05 UA UA2000127207A patent/UA73474C2/uk unknown
- 1999-05-05 ID IDW20002460A patent/ID27281A/id unknown
- 1999-05-05 CN CNB998061751A patent/CN1145479C/zh not_active Expired - Lifetime
- 1999-05-05 US US09/700,421 patent/US6646007B1/en not_active Expired - Lifetime
- 1999-05-05 SK SK1689-2000A patent/SK284155B6/sk not_active IP Right Cessation
- 1999-05-05 CA CA002333193A patent/CA2333193A1/en not_active Withdrawn
- 1999-05-05 DE DE59903028T patent/DE59903028D1/de not_active Expired - Lifetime
- 1999-05-05 HU HU0102125A patent/HU228958B1/hu unknown
- 1999-05-05 DK DK99922182T patent/DK1077681T3/da active
- 1999-05-05 ES ES99922182T patent/ES2184452T3/es not_active Expired - Lifetime
- 1999-05-12 MY MYPI99001885A patent/MY120570A/en unknown
- 1999-05-14 AR ARP990102301A patent/AR018607A1/es active IP Right Grant
- 1999-05-14 TW TW088107870A patent/TW561058B/zh not_active IP Right Cessation
-
2000
- 2000-11-14 NO NO20005758A patent/NO331655B1/no not_active IP Right Cessation
- 2000-12-14 ZA ZA200007509A patent/ZA200007509B/en unknown
-
2003
- 2003-09-15 US US10/661,588 patent/US8008349B2/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI603730B (zh) * | 2012-08-20 | 2017-11-01 | 馬克專利公司 | 含左旋甲狀腺素之固態醫藥製劑 |
| US11298331B2 (en) | 2012-08-20 | 2022-04-12 | Merck Patent Gmbh | Solid pharmaceutical preparation containing levothyroxine |
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| TW561058B (en) | Pharmaceutical preparation | |
| TW492878B (en) | Tablet composition | |
| JP4782364B2 (ja) | エストロゲン−シクロデキストリン複合体の組成物 | |
| CA2637925A1 (en) | Levetiracetam formulations and methods for their manufacture | |
| KR20120098878A (ko) | 용출 안정성 제제 | |
| BRPI0918530B1 (pt) | Granulado, seu uso e seu processo de produção, e composição. | |
| TW200306199A (en) | Stable salts of O-acetylsalicylic acid with basic amino acids II | |
| JP2020183382A (ja) | フィンゴリモド塩酸塩含有製剤及びフィンゴリモド塩酸塩含有製剤の製造方法 | |
| UA119855C2 (uk) | Фармацевтичні лікарські форми, які містять 1-[6-(морфолін-4-іл)піримідин-4-іл]-4-(1h-1,2,3-триазол-1-іл)-1h-піразол-5-олат натрію | |
| JPH0848632A (ja) | エトポシドを含有する固形組成物および固形製剤 | |
| TR2022003059A2 (tr) | Vi̇ldagli̇pti̇n i̇çeren bi̇r tableti̇n hazirlanmasina yöneli̇k bi̇r proses | |
| WO2024085821A1 (en) | Content uniformity of teriflunomid in pharmaceutical dosage forms | |
| JP2019210276A (ja) | 錠剤及びその製造方法 | |
| WO2019230017A1 (ja) | 錠剤及びその製造方法 | |
| JP2007169263A (ja) | 固形製剤および製剤組成物 | |
| JP2007246539A (ja) | 速溶性医薬組成物 | |
| ZA200305532B (en) | Compositions of estrogen-cyclodextrin complexes | |
| JP2004099497A (ja) | ペルゴリド含有医薬組成物 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GD4A | Issue of patent certificate for granted invention patent | ||
| MK4A | Expiration of patent term of an invention patent |