CN102755253A - Method for preparing freeze-dried tablet in connected medicine-accommodating vessel package - Google Patents
Method for preparing freeze-dried tablet in connected medicine-accommodating vessel package Download PDFInfo
- Publication number
- CN102755253A CN102755253A CN201210019157XA CN201210019157A CN102755253A CN 102755253 A CN102755253 A CN 102755253A CN 201210019157X A CN201210019157X A CN 201210019157XA CN 201210019157 A CN201210019157 A CN 201210019157A CN 102755253 A CN102755253 A CN 102755253A
- Authority
- CN
- China
- Prior art keywords
- drug
- containing dish
- medicament
- loam cake
- freeze
- 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.)
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Classifications
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
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- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
Abstract
The invention discloses a method for preparing a freeze-dried tablet in a connected medicine-accommodating vessel package, relating to the field of medicine preparation and subpackaging. The method comprises the following steps: filling a stoste for the freeze-dried tablet, performing semi-gland sealing, performing freeze drying, performing full-gland sealing and packaging with a composite film with an aluminum-containing upper layer and an aluminum-containing lower layer. By the method, the tablet can be frozen till being dry and moulded in a freeze drying box by one time and gland sealing is performed, the crimp and moisture absorption of a medicine-accommodating vessel and pollution of a medicine can be avoided and most of requirements on production of the freeze-dried tablet can be met; and the method is low in cost, simple in process and controllable in quality and is applicable to industrial mass production.
Description
Technical field
The present invention relates to medicine manufacturing and packing field, more particularly, relate to a kind of method improved, in the drug-containing dish packing of disposable single medicament, that make the lyophilized medication tablet.
Background technology
In recent years, the drug manufacturer protruding blister pack that has been widely used supplies medicinal tablet to be shaped and packing, and these protruding blister packs generally are made up of protruding bubble shape sheet or protruding bubble shape film and cover plate.Protruding bubble shape sheet comprises some depressions of holding single medicament.In the standard method that is used for making the lyophilization tablet, aqueous single medicament is introduced in the freezing environment, and in this environment, medicament runs into low temperature so that they are freezing.Afterwards, more protruding bubble shape sheet is moved into freeze dryer, at this, ice is owing to distillation is removed.When lyophilization was accomplished, protruding bubble shape sheet took out in the hothouse and covers with the cover plate of a viscosity, and this cover plate is sealed in solid medicament during each caves in.This is a kind of known method that is used to make the lyophilization tablet.
Yet the method has some weak points.At first, protruding bubble shape sheet is generally used the polymeric material manufacturing, and it can make moisture infiltrate in the protruding blister pack after a while and reach the stored medicament in the inside.For addressing this problem, developed some protruding bubble shape sheets, in these protruding bubble shape sheets, be laminated to layer of aluminum between two polymeric layers.The existence of aluminium lamination has prevented that moisture from infiltrating protruding blister pack, but it has brought second problem again.That is in refrigerating process, when running into variations in temperature, traditional aluminum/polymeric layer rolled-up stock will be because the difference of this laminate opposite layer on thermal expansion or shrinkage degree will be tending towards curling.This causes difficulty when they are used in refrigerating process, because flowing product possibly flow out from formed depression easily.Unique solution is on the limit of laminate, to use weight, so as to make they keep enough flat.But such way is unpractiaca in large batch of manufacturing work the time, but and interfere refrigerating process.
Also has a kind of improved method (Zydis method) that is used to be manufactured on the lyophilization dosage form in the protruding blister pack of aluminum.Medicament is introduced in the depression of protruding bubble shape sheet as a kind of liquid.Protruding bubble shape sheet comprises the intermediate layer of a sealing between first and second skins; And each skin has same whole thermal coefficient of expansion in fact; Though it has solved the problem that protruding bubble shape sheet curls; But also have medicament risk of the moisture absorption in contaminated and the packaging process when lyophilization, because medicinal liquid exposes in freezing dry process all the time, and dried medicament seals after can only taking out freeze drying box.
Therefore, this just needs a kind of curling problem that can be avoided protruding bubble shape sheet, again can be when the medicament lyophilization, and medicinal liquid is not contaminated, and can in freeze drying box, seal and not have the method for moisture absorption risk fully after the medicament molding.
Summary of the invention
The present invention is a kind of improved, is used to make the method for lyophilization dosage form.Medicament is packed into as a kind of liquid in the continuous cylindrical drug-containing dish; Drug-containing dish loam cake half gland that has aperture to lower edge is put into freeze drying box with drug-containing dish, after medicament is freezing on drug-containing dish; Evacuation is dry; After treating the medicament drying, cover drug-containing dish loam cake total head on drug-containing dish and to seal, outlet, cutting, with double-deck aluminous layer composite film packaging up and down.This method can make medicament a lyophilizing molding and gland seal in freeze drying box.Can prevent that the curling of medicine container, the moisture absorption and medicament are contaminated, can satisfy the production requirement of most of lyophilizing tablet, with low cost, technology is simple, quality controllable, be fit to industrialized great production.
Description of drawings
Fig. 1 is the plane graph of drug-containing dish
Fig. 2 is the profile of medicinal liquid when packing in the drug-containing dish
Fig. 3 is the profile that has the drug-containing dish loam cake of vapor opening
Profile when Fig. 4 is drug-containing dish half gland
Profile when Fig. 5 is drug-containing dish total head lid
Fig. 6 is the good medicine profile of double-deck aluminous layer composite film packaging up and down
The specific embodiment
Below in conjunction with marginal data specific embodiments of the present invention, the present invention relates to make and the packing drug world, more particularly, relate to a kind of method improved, in the drug-containing dish packing of disposable single medicament, that make the lyophilized medication tablet.
As shown in Figure 1, for the ease of suitability for industrialized production, and the one-shot forming packing, drug-containing dish 10 bottoms are with dowel 11 interconnective cylinders or other any geometries.Drug-containing dish 10 comprises polyethylene, polyamide, polrvinyl chloride, polypropylene or other material that can meet the demands by the polymer manufacturing.The size of drug-containing dish 10, shape and number can be selected according to size, loading amount, character and industrialization production capacity and other consideration decisions of professional and technical personnel of medicament.
As shown in Figure 2, liquid preparation 30 is packed in the drug-containing dish 10, and liquid preparation 30 does not overflow drug-containing dish 10 and satisfies the content requirement of medicament.
As shown in Figure 3, drug-containing dish loam cake 20 is by the polymer manufacturing identical with drug-containing dish 10, and drug-containing dish loam cake 20 lower edges have the vapor opening 21 of any geometry, drug-containing dish loam cake 20 can and drug-containing dish 10 agree with each other.
As shown in Figure 4, with liquid preparation 30 drug-containing dish 10 of packing into, drug-containing dish loam cake 20 half glands on drug-containing dish 10, vapor opening 21 so both can prevent that liquid preparation 30 was contaminated more than drug-containing dish 10 top edges, can not influence the freeze-drying process of medicament again.
As shown in Figure 5, liquid single medicament 30 is through freezing (cryogenic temperature is at-20 ℃ to-80 ℃), the evacuation drying (baking temperature by-20 ℃ to-80 ℃ slowly rise to+5 ℃ to+50 ℃; Vacuum is at 0.1 to 20.0 handkerchief); After treating medicament 30 dryings, in freeze drying box, drug-containing dish loam cake 20 total heads are covered on drug-containing dish 10, medicament 30 is sealed in the drug-containing dish 10;, prevented dried medicament moisture absorption again after going out freeze drying box like this.
As shown in Figure 6, the drug-containing dish that links to each other after the drying sealing is taken out and is cut into single medicament, and with about double-deck aluminous layer composite membrane 40 pack, aluminous layer composite membrane 40 aluminum layer thickness are not less than 20 microns.Behind the single Drug packing, reserve opening 41, be convenient to the taking-up of medicament.
The preferred embodiments of the present invention have been described in front, should be understood that this professional those of ordinary skill can also make various improvement and variation, but these have been all within design of the present invention described in claims and scope.
Claims (6)
1. a method that is used to be manufactured on lyophilization tablet in the continuous drug-containing dish packing comprises
A) introduce the medicament of liquid in the drug-containing dish;
B) drug-containing dish loam cake half gland on drug-containing dish, prevent that medicinal liquid is contaminated;
C) freezing medicament;
D) the dry medicament of evacuation;
E) cover drug-containing dish loam cake total head on drug-containing dish the sealing medicament;
F) be cut into single drug-containing dish;
G) packing drug-containing dish.
2. the method for claim 1, wherein drug-containing dish and drug-containing dish loam cake are by the polymer manufacturing.
3. method as claimed in claim 2, wherein polymeric material comprises that mainly one or more polymer of choosing in polyethylene, polyamide, polrvinyl chloride and polyacrylic group form.
4. the method for claim 1, wherein drug-containing dish is interconnective cylindrical or other geometry in bottom, the number that drug-containing dish connects is 2 or more than 2.
5. method as claimed in claim 4, wherein drug-containing dish loam cake lower edge has vapor opening, and drug-containing dish loam cake vapor opening number is more than 2 or 2, is shaped as random geometry.
6. the method for claim 1 is packed one or more drug-containing dishes with the packaging material of aluminous layer composite membrane.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210019157XA CN102755253A (en) | 2012-01-17 | 2012-01-17 | Method for preparing freeze-dried tablet in connected medicine-accommodating vessel package |
| PCT/CN2012/079131 WO2013107173A1 (en) | 2012-01-17 | 2012-08-23 | Method for preparing freeze-dried tablet in connected medicine-accommodating vessel package |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210019157XA CN102755253A (en) | 2012-01-17 | 2012-01-17 | Method for preparing freeze-dried tablet in connected medicine-accommodating vessel package |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102755253A true CN102755253A (en) | 2012-10-31 |
Family
ID=47050074
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210019157XA Pending CN102755253A (en) | 2012-01-17 | 2012-01-17 | Method for preparing freeze-dried tablet in connected medicine-accommodating vessel package |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN102755253A (en) |
| WO (1) | WO2013107173A1 (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4642903A (en) * | 1985-03-26 | 1987-02-17 | R. P. Scherer Corporation | Freeze-dried foam dosage form |
| JP2003267471A (en) * | 2002-03-15 | 2003-09-25 | Nipro Corp | Protecting external packaging bag for container for freezing and storing living tissue |
| CN101146506A (en) * | 2005-03-25 | 2008-03-19 | 尼普洛株式会社 | Package of freeze storage container and process for producing the same |
| WO2010125084A1 (en) * | 2009-04-29 | 2010-11-04 | Intervet International B.V. | Process to form a tablet and apparatus suitable for applying this process |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA1097233A (en) * | 1977-07-20 | 1981-03-10 | George K. E. Gregory | Packages |
| US5334162A (en) * | 1993-03-15 | 1994-08-02 | Eli Lilly And Company | Cartridge assembly for a lyophilized compound forming a disposable portion of an injector pen and method for same |
| GB9827292D0 (en) * | 1998-12-12 | 1999-02-03 | Univ Strathclyde | Freeze drying |
| CN201076602Y (en) * | 2007-09-28 | 2008-06-25 | 宁波立华制药有限公司 | Medicine clad plate |
| JP2010124931A (en) * | 2008-11-26 | 2010-06-10 | Kanae Co Ltd | Method for manufacturing package of freeze-dried medicine |
-
2012
- 2012-01-17 CN CN201210019157XA patent/CN102755253A/en active Pending
- 2012-08-23 WO PCT/CN2012/079131 patent/WO2013107173A1/en active Application Filing
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4642903A (en) * | 1985-03-26 | 1987-02-17 | R. P. Scherer Corporation | Freeze-dried foam dosage form |
| JP2003267471A (en) * | 2002-03-15 | 2003-09-25 | Nipro Corp | Protecting external packaging bag for container for freezing and storing living tissue |
| CN101146506A (en) * | 2005-03-25 | 2008-03-19 | 尼普洛株式会社 | Package of freeze storage container and process for producing the same |
| WO2010125084A1 (en) * | 2009-04-29 | 2010-11-04 | Intervet International B.V. | Process to form a tablet and apparatus suitable for applying this process |
Non-Patent Citations (2)
| Title |
|---|
| 《工程科技I辑》 20100131 蒋猛 "多西紫杉醇的冻干制剂工艺及质量研究" B016-87, 第21页第3-5段 1-6 , * |
| 蒋猛: ""多西紫杉醇的冻干制剂工艺及质量研究"", 《工程科技I辑》 * |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2013107173A1 (en) | 2013-07-25 |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20121031 |