JPH02214A - Drug preparation for intranasal administration - Google Patents
Drug preparation for intranasal administrationInfo
- Publication number
- JPH02214A JPH02214A JP63263415A JP26341588A JPH02214A JP H02214 A JPH02214 A JP H02214A JP 63263415 A JP63263415 A JP 63263415A JP 26341588 A JP26341588 A JP 26341588A JP H02214 A JPH02214 A JP H02214A
- Authority
- JP
- Japan
- Prior art keywords
- igf
- acid ester
- fatty acid
- preparation
- sucrose fatty
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000003814 drug Substances 0.000 title abstract description 6
- 229940079593 drug Drugs 0.000 title abstract description 3
- 108090000723 Insulin-Like Growth Factor I Proteins 0.000 claims abstract description 22
- 102000004218 Insulin-Like Growth Factor I Human genes 0.000 claims abstract description 20
- -1 sucrose fatty acid ester Chemical class 0.000 claims abstract description 17
- 229930006000 Sucrose Natural products 0.000 claims abstract description 15
- 239000005720 sucrose Substances 0.000 claims abstract description 15
- 235000014113 dietary fatty acids Nutrition 0.000 claims abstract description 13
- 229930195729 fatty acid Natural products 0.000 claims abstract description 13
- 239000000194 fatty acid Substances 0.000 claims abstract description 13
- 239000000203 mixture Substances 0.000 claims abstract description 9
- SZYSLWCAWVWFLT-UTGHZIEOSA-N [(2s,3s,4s,5r)-3,4-dihydroxy-5-(hydroxymethyl)-2-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxolan-2-yl]methyl octadecanoate Chemical group O([C@@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@]1(COC(=O)CCCCCCCCCCCCCCCCC)O[C@H](CO)[C@@H](O)[C@@H]1O SZYSLWCAWVWFLT-UTGHZIEOSA-N 0.000 claims description 3
- POULHZVOKOAJMA-UHFFFAOYSA-M dodecanoate Chemical compound CCCCCCCCCCCC([O-])=O POULHZVOKOAJMA-UHFFFAOYSA-M 0.000 claims 1
- IPCSVZSSVZVIGE-UHFFFAOYSA-M hexadecanoate Chemical compound CCCCCCCCCCCCCCCC([O-])=O IPCSVZSSVZVIGE-UHFFFAOYSA-M 0.000 claims 1
- 229940070765 laurate Drugs 0.000 claims 1
- 150000002148 esters Chemical class 0.000 abstract description 4
- 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 abstract description 3
- 102000013275 Somatomedins Human genes 0.000 abstract description 2
- 235000021355 Stearic acid Nutrition 0.000 abstract description 2
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 abstract description 2
- 239000008117 stearic acid Substances 0.000 abstract description 2
- 239000005639 Lauric acid Substances 0.000 abstract 1
- 235000021314 Palmitic acid Nutrition 0.000 abstract 1
- 238000010521 absorption reaction Methods 0.000 abstract 1
- POULHZVOKOAJMA-UHFFFAOYSA-N methyl undecanoic acid Natural products CCCCCCCCCCCC(O)=O POULHZVOKOAJMA-UHFFFAOYSA-N 0.000 abstract 1
- WQEPLUUGTLDZJY-UHFFFAOYSA-N n-Pentadecanoic acid Natural products CCCCCCCCCCCCCCC(O)=O WQEPLUUGTLDZJY-UHFFFAOYSA-N 0.000 abstract 1
- IPCSVZSSVZVIGE-UHFFFAOYSA-N n-hexadecanoic acid Natural products CCCCCCCCCCCCCCCC(O)=O IPCSVZSSVZVIGE-UHFFFAOYSA-N 0.000 abstract 1
- 230000000694 effects Effects 0.000 description 5
- 238000009472 formulation Methods 0.000 description 5
- 102000018997 Growth Hormone Human genes 0.000 description 4
- 108010051696 Growth Hormone Proteins 0.000 description 4
- 239000000122 growth hormone Substances 0.000 description 4
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 229940124597 therapeutic agent Drugs 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 2
- 210000003928 nasal cavity Anatomy 0.000 description 2
- 108090000765 processed proteins & peptides Proteins 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000011282 treatment Methods 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 206010002091 Anaesthesia Diseases 0.000 description 1
- 208000010392 Bone Fractures Diseases 0.000 description 1
- 206010013883 Dwarfism Diseases 0.000 description 1
- 102000004877 Insulin Human genes 0.000 description 1
- 108090001061 Insulin Proteins 0.000 description 1
- 208000001132 Osteoporosis Diseases 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 208000025865 Ulcer Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000001195 anabolic effect Effects 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 239000003899 bactericide agent Substances 0.000 description 1
- 230000008468 bone growth Effects 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 238000005119 centrifugation Methods 0.000 description 1
- 210000001612 chondrocyte Anatomy 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 150000005690 diesters Chemical class 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 150000002027 dodecanoic acid esters Chemical class 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 210000003238 esophagus Anatomy 0.000 description 1
- 230000032050 esterification Effects 0.000 description 1
- 238000005886 esterification reaction Methods 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 238000010353 genetic engineering Methods 0.000 description 1
- 239000007952 growth promoter Substances 0.000 description 1
- 239000000017 hydrogel Substances 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 229940125396 insulin Drugs 0.000 description 1
- 230000002608 insulinlike Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 210000004379 membrane Anatomy 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 210000002850 nasal mucosa Anatomy 0.000 description 1
- 239000007922 nasal spray Substances 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- 150000002943 palmitic acids Chemical class 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 208000003068 pituitary dwarfism Diseases 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001184 polypeptide Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 230000035755 proliferation Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 238000011321 prophylaxis Methods 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 238000003127 radioimmunoassay Methods 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 210000001321 subclavian vein Anatomy 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 210000003437 trachea Anatomy 0.000 description 1
- 150000005691 triesters Chemical class 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
【発明の詳細な説明】
［産業上の利用分野］
この発明はインスリン様成長因子Ｉ（以下、ＩＧＦ−１
と称する）およびシＢ＄１！脂肪酸エステルを含有する
鼻腔内投与用製剤に関する。[Detailed Description of the Invention] [Industrial Application Field] This invention relates to insulin-like growth factor I (hereinafter referred to as IGF-1).
) and shiB$1! The present invention relates to a formulation for intranasal administration containing a fatty acid ester.
［従来の技＃ｌ］
ＩＧＦ−１は血中に存在するインスリンＪｉｌＨＧＩの
ペプチドであり、種々の細胞の増殖促進作用を有してお
り、その産生および分泌は成長ホルモンに依存している
。[Conventional Technique #1] IGF-1 is a peptide of insulin JilHGI present in the blood, and has a proliferation-promoting effect on various cells, and its production and secretion are dependent on growth hormone.
ＩＧＦ−１は成長ホルモンの骨成長促進作用を仲介する
物質であるソマトメジン群炬含まれるが、特にＩＧＦ−
１は成長ホルモン依存性が高く、ソマトメジンＣと同一
の物質であり、成長ホルモンの作用の発現に深く関与し
ていることが知られている。IGF-1 is included in the somatomedin group, which is a substance that mediates the bone growth promoting effect of growth hormone.
1 is highly dependent on growth hormone, is the same substance as somatomedin C, and is known to be deeply involved in the expression of the action of growth hormone.
近年、このＩＧＦ−Ｉは遺伝子工学的手法により比較的
容易に生産することが可能になり、成長促進作用から下
垂体性小人症の治療剤、低身長者の成長促進剤として、
軟骨細胞増殖作用から骨粗軽症の予功治療剤として、あ
るいは骨折の治療剤として、インスリン様作用から糠床
病の治療剤として、さらにたんばく同化作用から潰瘍、
外傷、火傷の治療剤などとしての用途が知られている。In recent years, it has become possible to produce IGF-I relatively easily using genetic engineering techniques, and due to its growth-promoting effect, it has been used as a treatment for pituitary dwarfism and as a growth promoter for short people.
Due to its chondrocyte proliferation effect, it can be used as a prophylactic treatment for osteoporosis, as a therapeutic agent for bone fractures, because of its insulin-like effect as a therapeutic agent for bran bed disease, and because of its protein anabolic effect, it can be used as a treatment for ulcers and fractures.
It is known to be used as a therapeutic agent for injuries and burns.
しかしながら、ＩＧＦ−Ｉは、高分子量のポリペプテド
であるため膜透過性が低く、また、消化器で分解され易
いことから経口投与では体内に吸収され難いという難点
があり、臨床における投与形態は注射に限られている。However, since IGF-I is a high molecular weight polypeptide, it has low membrane permeability and is easily degraded in the digestive tract, making it difficult to absorb into the body when administered orally. limited.
［問題点を解決するための手段コ
この発明の発明者らは、より簡便で且つ効果が速やかに
発現するＩＧＦ−Ｉの投与形態について鋭意研究の結果
、ＩＧＦ−１を鼻腔内投与用製剤とすれば、ＩＧＦ−Ｉ
が速やかに体内に吸収されることを、見出し、この発明
を完成した。[Means for Solving the Problems] The inventors of the present invention have conducted intensive research into a form of administration of IGF-I that is simpler and more quickly effective, and have developed a formulation for intranasal administration of IGF-1. Then, IGF-I
They discovered that it was quickly absorbed into the body and completed this invention.
この発明による鼻腔内投与用製剤はＩＧＦ−１およびシ
ョ糖脂肪酸エステルを含有する。The intranasal formulation according to the invention contains IGF-1 and sucrose fatty acid ester.
ショ糖脂肪酸エステルとしてはショ糖のステアノン酸エ
ステル、パルミチン酸エステル、ラウリン酸エステルな
どが挙げられる。これらのショ糖脂肪酸エステルはエス
テル化の程度によってモノエステノ呟ジエステルおよび
トリエステルの３種が存在するが、この発明の目的のた
めには、これらを単独または混合物として用いることが
できる。Examples of sucrose fatty acid esters include stearonic acid esters, palmitic acid esters, and lauric acid esters of sucrose. These sucrose fatty acid esters exist in three types, monoesters, diesters and triesters, depending on the degree of esterification, and for the purpose of this invention, these can be used alone or as a mixture.
そして、そのＨＬＢが１０以上であるものまたは１０以
−ヒになるように配合したものを用いると最も適確な効
果が得られる。The most appropriate effect can be obtained by using a compound whose HLB is 10 or more, or a compound blended so that the HLB is 10 or more.
この製剤はＩＧＦ−Ｉおよびショ糖脂肪酸エステルを鼻
粘膜に適用できる水などの液体希釈剤に溶解して水性溶
液もしくはヒドロゲルとするか、または粉末状の担体中
に希釈して粉末状製剤とすることによって得られる。ま
た、適当な殺菌剤、防腐剤、増粘剤、界面活性剤、安定
剤などを含有していてもよい。This preparation is made by dissolving IGF-I and sucrose fatty acid ester in a liquid diluent such as water that can be applied to the nasal mucosa to form an aqueous solution or hydrogel, or by diluting it in a powdered carrier to form a powder preparation. obtained by It may also contain appropriate bactericidal agents, preservatives, thickeners, surfactants, stabilizers, and the like.
この発明の製剤におけるＩＧＦ−１の好ましい含量は、
製剤１ ｍＱ当り１〜１００ｍｇであり、ショ糖脂肪酸
エステルの含量はＩＧＦ−Ｉの含量の２〜２０倍程度が
好ましい。The preferred content of IGF-1 in the formulation of this invention is:
The amount is 1 to 100 mg per mQ of the preparation, and the content of sucrose fatty acid ester is preferably about 2 to 20 times the content of IGF-I.
投与形態としては、滴下容器、スプレー容器、または鼻
腔用エアゾールアプリケーターなどを用いて、鼻腔内に
滴下あるいは噴霧投与する方法が適している。Suitable dosage forms include intranasal drip or spray administration using a drip container, spray container, nasal aerosol applicator, or the like.
［発明の効果コ 試験例によりこの発明をさらに詳しく説明する。[Effects of invention The present invention will be explained in more detail using test examples.
区！週
試験法ニ
ラノド（ＳＤ系雄、７週令、平均体重２４０ｇ）を背位
固定し、麻酔下で前頚部を縦切開し、気管を露出させ、
ポリエチレンチューブをカニユーレし、気道を確保した
後、食道を結紮した。Ward! Weekly test method: A Nira-throat (SD male, 7 weeks old, average weight 240 g) was fixed in a dorsal position, and under anesthesia a longitudinal incision was made in the front neck to expose the trachea.
After cannulating the polyethylene tube and securing the airway, the esophagus was ligated.
後記の実施例１で調製した薬液をマイクロシリンジで１
００ｄ／ｋｇの割合で鼻腔内に投与し、直後にアロンア
ルファ（商標、東亜合成化学工業■製）で鼻腔入口をふ
さいだ。Add the drug solution prepared in Example 1 below using a microsyringe.
It was administered into the nasal cavity at a rate of 00 d/kg, and the nasal cavity entrance was immediately blocked with Aron Alpha (trademark, manufactured by Toagosei Kagaku Kogyo ■).
投与後、経時的に鎖骨下静脈より採血し、遠心分離後、
血漿を得、ラジオイムノアッセイ法により血漿中のＩＧ
Ｆ−Ｉ ｍ度を測定した。対照として、ＩＧＦ −１５
ｍｇを生理食塩水に溶がし、全量をｌ ｍＱとしたもの
について同様の試験を行った。After administration, blood was collected from the subclavian vein over time, and after centrifugation,
Plasma was obtained, and IG in the plasma was determined by radioimmunoassay.
The F-I m degree was measured. As a control, IGF-15
A similar test was conducted using mg dissolved in physiological saline and the total amount taken as l mQ.
試験結果：
投与後、０．２５．０．５．１．２．４．６時間後のＩ
ＧＦ−１の血中濃度（ｎｇ／ｍｌ）は次表の通りであっ
た。Test results: I 0.25.0.5.1.2.4.6 hours after administration
The blood concentration (ng/ml) of GF-1 was as shown in the following table.
［実施例コ この発明の製剤の調製例を実施例により説明する。[Example code] Examples of the preparation of the formulation of this invention will be explained by way of examples.
実施例Ｉ
ＩＧＦ−１５ｍｇおよびＤＫニスデルＦ−１６０（商標
、第−工業製薬株式会社製、ショ糖ステアリン酸モノエ
ステルまたはシラ糖バルミチン酸モノエステル７０％お
よびシヨ糖ステアリン酸ジ（またはトノ）エステルまた
はシヨ糖ステアリン酸ジ（またはトリ）エステル３０％
からなるＨＬＢ１５のショ糖脂肪酸エステル） ４０ｍ
ｇを蒸留水に溶解して、全量をｌｌｌｌ１１とした。Example I IGF-15mg and DK Nisdel F-160 (trademark, manufactured by Dai-Kogyo Seiyaku Co., Ltd., 70% sucrose stearate monoester or silasugar balmitate monoester and sucrose stearate di(or tono)ester or 30% sucrose stearic acid di(or tri)ester
(Sucrose fatty acid ester with HLB15 consisting of) 40m
g was dissolved in distilled water to make a total volume of lllll11.
Claims (3)
ステルを含有することを特徴とする鼻腔内投与用製剤。(1) A preparation for intranasal administration characterized by containing insulin-like growth factor I and sucrose fatty acid ester.
ステル、パルミチン酸エステルもしくはラウリン酸エス
テルまたはそれらの混合物である特許請求の範囲第１項
に記載の製剤。(2) The preparation according to claim 1, wherein the sucrose fatty acid ester is a sucrose stearate, palmitate, or laurate, or a mixture thereof.
特許請求の範囲第１項および第２項のいずれかに記載の
製剤。(3) The preparation according to any one of claims 1 and 2, wherein the HLB of the sucrose fatty acid ester is 10 or more.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP63263415A JP2590548B2 (en) | 1987-10-27 | 1988-10-19 | Formulation for intranasal administration |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP62-271264 | 1987-10-27 | ||
| JP27126487 | 1987-10-27 | ||
| JP63263415A JP2590548B2 (en) | 1987-10-27 | 1988-10-19 | Formulation for intranasal administration |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH02214A true JPH02214A (en) | 1990-01-05 |
| JP2590548B2 JP2590548B2 (en) | 1997-03-12 |
Family
ID=26546009
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP63263415A Expired - Fee Related JP2590548B2 (en) | 1987-10-27 | 1988-10-19 | Formulation for intranasal administration |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2590548B2 (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1998046269A1 (en) * | 1997-04-14 | 1998-10-22 | Tt Pharmaceuticals, Inc. | Permucous preparation |
| US7273618B2 (en) | 1998-12-09 | 2007-09-25 | Chiron Corporation | Method for administering agents to the central nervous system |
| EP4249175A1 (en) | 2022-03-23 | 2023-09-27 | Nabtesco Corporation | Rotation mechanism and robot |
-
1988
- 1988-10-19 JP JP63263415A patent/JP2590548B2/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1998046269A1 (en) * | 1997-04-14 | 1998-10-22 | Tt Pharmaceuticals, Inc. | Permucous preparation |
| US6228836B1 (en) | 1997-04-14 | 2001-05-08 | Mitsubishi-Tokyo Pharmaceuticals, Inc. | Permucous preparation |
| US7273618B2 (en) | 1998-12-09 | 2007-09-25 | Chiron Corporation | Method for administering agents to the central nervous system |
| EP4249175A1 (en) | 2022-03-23 | 2023-09-27 | Nabtesco Corporation | Rotation mechanism and robot |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2590548B2 (en) | 1997-03-12 |
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