CN110732020B - Stable pharmaceutical formulation containing polyethylene glycol lozenges - Google Patents
Stable pharmaceutical formulation containing polyethylene glycol lozenges Download PDFInfo
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- CN110732020B CN110732020B CN201911165551.2A CN201911165551A CN110732020B CN 110732020 B CN110732020 B CN 110732020B CN 201911165551 A CN201911165551 A CN 201911165551A CN 110732020 B CN110732020 B CN 110732020B
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- pharmaceutical composition
- polyethylene glycol
- dextran
- weight ratio
- sorbitol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/26—Glucagons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
Abstract
The invention provides a stable pharmaceutical preparation containing polyethylene glycol lozenith peptide, and provides a pharmaceutical composition containing polyethylene glycol lozenith peptide and a preparation method thereof. The pharmaceutical composition contains polyethylene glycol lozenithal, excipient and PH regulator. The prescription and the process of the pharmaceutical composition provided by the invention are scientific and reasonable, so that the stability of the polyethylene glycol lozenithal drug is improved to a great extent, and the effective period of the pharmaceutical composition is prolonged.
Description
Technical Field
The invention relates to the field of polypeptide pharmaceutical preparations. In particular, the invention relates to storage stable pharmaceutical formulations comprising polyethylene glycol lozenges.
Background
Polyethylene glycol lozena peptide is a 1.1-class innovative drug independently developed by Jiangsu haoshen, is the first PEGylated long-acting hypoglycemic drug in China and is global, and only needs to be injected one time a week, and has the following structure:
the polyethylene glycol lozenges are obtained by modifying Exenatide through amino acid modification and PEGylation, so that the Exenatide can further resist DPP-4 rapid degradation in vivo, and simultaneously the polyethylene glycol (PEG) modification can reduce toxicity of the medicine, prolong half-life and action time of the medicine in vivo and improve the medicineThe bioavailability is improved, the treatment effect of the medicine is further improved, the administration interval is prolonged, the administration times are reduced, and the patient compliance is improved on the premise of ensuring the curative effect. Clinical studies show that polyethylene glycol lozenithal has an in vivo half-life t 1/2 Can reach about 80 hours, and is far higher than Exenatide; shows good glucose-dependent insulinotropic function in normal rats and shows dose dependency. After the db/db mice with type 2 diabetes mellitus are subcutaneously injected once every 3 days, the random, fasting blood glucose and serum fructosamine levels of the mice can be obviously reduced, the glucose tolerance is improved, the weight is reduced, and the drug effect is equivalent to that of Exenatide which is subcutaneously injected twice a day.
Polyethylene glycol lozenith shows good blood sugar reducing effect on diabetes classical model animals, has obvious type 2 diabetes treatment effect, and can avoid adverse reactions of hypoglycemia and weight gain. Compared with Exenatide, the drug has the characteristic of long acting, obviously reduces the invasive administration times and has better development prospect.
Polypeptide drugs are widely used in clinical research or treatment processes at present. Stable, high quality, therapeutic polypeptide pharmaceutical formulations that can be produced industrially remain a significant challenge for researchers. Different preparation processes and different kinds of stabilizers are adopted and are commonly used in the development of polypeptide pharmaceutical preparations so as to improve the stability of the polypeptide pharmaceutical preparations. For parenteral formulations, the shelf life is at least one year or more. Considering that polyethylene glycol lozenges are easy to degrade under the conditions of illumination, high temperature and oxidation, and considering the temperature change and vibration condition of a sample in the transportation process, it is necessary to further improve the stability of polyethylene glycol lozenges injection and prolong the storage life of the polyethylene glycol lozenges.
Disclosure of Invention
The invention aims to provide a polyethylene glycol lozenith peptide pharmaceutical composition with better stability and longer storage life.
Specifically, the invention is mainly implemented by the following scheme:
a polyethylene glycol lozenith peptide pharmaceutical composition, which comprises an active ingredient polyethylene glycol lozenith peptide, an excipient and a pH regulator.
Preferably, the excipient is sorbitol and dextran selected from dextran 20 or dextran 40.
More preferably, the weight ratio of sorbitol to dextran is 1:3 to 3:1, preferably 1:3 to 1:1, more preferably 1:3 to 1:2.
Preferably, the weight ratio of active ingredient to excipient is 1:5 to 20, preferably 1:7 to 12.
Preferably, the pharmaceutical composition is a lyophilized preparation, and the moisture of the lyophilized preparation is less than or equal to 2.0%, preferably 0.5% -1.0%.
Preferably, the pH adjuster is acetic acid.
Preferably, the weight percentage of the prescription of the active ingredient is 5-15%, preferably 7-15%.
Preferably, the weight percentage of the sorbitol prescription is 20-45%, preferably 20-40%; the prescription weight ratio of the dextran is 40-75%, preferably 50-70%.
Preferably, the weight ratio of the components of the invention is as follows:
polyethylene glycol lobetade 1 part
2-3 parts of sorbitol
5-10 parts of dextran;
preferably, the weight ratio of the components is as follows:
polyethylene glycol lobetade 1 part
Sorbitol 2.8 parts
8.5 parts of dextran;
or (b)
Polyethylene glycol lobetade 1 part
Sorbitol 2.8 parts
5.7 parts of dextran.
Preferably, the weight percentages of the components of the invention are as follows:
polyethylene glycol loxenalapril 8.1%
Sorbitol 68.9%
Dextran 23%.
Preferably, the weight percentages of the components of the invention are as follows:
polyethylene glycol loxenalapril 10.5%
Sorbitol 29.8%
Dextran 59.6%.
Preferably, the pH range of the polyethylene glycol lozenges peptide pharmaceutical composition is 4.0-6.0, preferably 5.0-5.5.
Preferably, the unit dose of the polyethylene glycol lozenith peptide pharmaceutical composition is 10 mg-30 mg, preferably 1.06mg or 2.12mg, calculated by polyethylene glycol lozenith peptide.
In another aspect, the present invention provides a process for preparing a polyethylene glycol lozenges pharmaceutical composition comprising the steps of:
the preparation method comprises the steps of dissolving excipient with a prescription amount in 80% of water for injection by volume, and stirring and dissolving.
And (3) taking the polyethylene glycol lozenith with the prescription amount, adding the polyethylene glycol lozenith into the solution, stirring and dissolving, and adding a proper amount of acetic acid to adjust the pH to 4.0-6.0.
The water for injection is added to the mixture, and the volume is fixed to 100% by volume.
And (3) filtering, filling, freeze-drying, tamponading and capping to obtain the polyethylene glycol lozenges peptide pharmaceutical composition.
Preferably, the method comprises the following steps:
the preparation method comprises the steps of taking excipient with a prescription amount, dissolving the excipient in 80% of water for injection by volume, controlling the temperature of the water for injection to be 15-25 ℃, and stirring and dissolving the excipient.
And (3) taking the polyethylene glycol lozenith with the prescription amount, adding the polyethylene glycol lozenith into the solution, stirring and dissolving, and adding a proper amount of acetic acid to adjust the pH to 5.0-5.5.
The water for injection is added to the mixture, and the volume is fixed to 100% by volume.
And (3) filtering by using 2 PES filter cores with the diameter of 0.22 mu m, filling under the aseptic condition, freeze-drying, tamponading and capping to obtain the polyethylene glycol lozenges peptide pharmaceutical composition.
Preferably, the freeze drying process is pre-freezing for 4-8 hours at-40 ℃ to-50 ℃, primary drying is carried out at 0 ℃ to 10 ℃ for 20-26 hours, and secondary drying is carried out at 25 ℃ to 35 ℃ for 10-20 hours.
Preferably, the lyophilization effluent is broken with nitrogen.
The process of the invention can obtain the pharmaceutical composition with the bacterial endotoxin meeting the regulations without using activated carbon. Through prescription screening, sorbitol and dextran are adopted as excipients, a stabilizer is not required to be added, and meanwhile, the stability of the polyethylene glycol lozenges peptide pharmaceutical composition is improved to a great extent through a freeze drying process, and the validity period of the pharmaceutical composition is prolonged.
Detailed Description
The invention is further illustrated by the following examples, which are not to be construed as further limiting. Those skilled in the art will readily appreciate that the specific methods and results described are merely illustrative.
Example 1
The prescribed amounts of dextran 40 and sorbitol were weighed and dissolved in 400ml of water for injection with stirring. Weighing polyethylene glycol lozenges of a prescription amount, slowly stirring to dissolve, adding a proper amount of acetic acid according to needs, adjusting the pH value to 5, adopting water for injection to fix the volume of the solution to 500ml, filtering the liquid medicine by using a PES microporous filter membrane of 0.22 mu m, subpackaging into penicillin bottles, half-pressing, and preparing for freeze-drying.
The freeze-drying process is to pre-freeze at-45 ℃ for 6 hours, perform primary drying at 10 ℃ for 25 hours, perform secondary drying at 30 ℃ for 16 hours.
Example 2
The prescribed amounts of dextran 20 and sorbitol and sodium acetate were weighed and dissolved in 400ml of water for injection with magnetic stirring. Weighing polyethylene glycol lozenith in a prescription amount, slowly stirring to dissolve, adding a proper amount of acetic acid, adjusting the pH to 5, adopting water for injection to fix the volume of the solution to 500ml, finally filtering the liquid medicine by using a PES microporous filter membrane with the thickness of 0.22 mu m, subpackaging into penicillin bottles, half-pressing, and preparing for freeze-drying.
The freeze-drying process is pre-freezing for 4 hours at-50 ℃, primary drying at 0 ℃ for 20 hours, and secondary drying at 25 ℃ for 18 hours.
Example 3
The prescribed amounts of dextran 40 and sorbitol were weighed and dissolved in 400ml of water for injection with magnetic stirring. Weighing polyethylene glycol lozenith in a prescription amount, slowly stirring to dissolve, adding a proper amount of acetic acid, adjusting the pH to 5, adopting water for injection to fix the volume of the solution to 500ml, finally filtering the liquid medicine by using a PES microporous filter membrane with the thickness of 0.22 mu m, subpackaging into penicillin bottles, half-pressing, and preparing for freeze-drying.
The freeze-drying process is to pre-freeze at-45 ℃ for 6 hours, perform primary drying at 10 ℃ for 25 hours, perform secondary drying at 30 ℃ for 16 hours.
Example 4
The prescribed amounts of dextran 40 and sorbitol were weighed and dissolved in 400ml of water for injection with magnetic stirring. Weighing polyethylene glycol lozenges of a prescription amount, slowly stirring to dissolve, adding a proper amount of acetic acid, adjusting the pH value to 5.5, adopting water for injection to fix the volume of the solution to 500ml, finally filtering the liquid medicine by using a PES microporous filter membrane of 0.22 mu m, subpackaging into penicillin bottles, half-pressing and preparing for freeze-drying.
The freeze-drying process is to pre-freeze at-45 ℃ for 6 hours, perform primary drying at 10 ℃ for 25 hours, perform secondary drying at 30 ℃ for 16 hours.
Example 5
Polyethylene glycol loxenapeptide 2.12g
Sorbitol 15g
The water for injection is added to 500ml
The prescribed amount of sorbitol was weighed and dissolved in 400ml of water for injection, and stirred for dissolution. Weighing polyethylene glycol lozenith in a prescription amount, slowly stirring to dissolve, adding a proper amount of acetic acid, adjusting the pH to 5, adopting water for injection to fix the volume of the solution to 500ml, finally filtering the liquid medicine by using a PES microporous filter membrane with the thickness of 0.22 mu m, subpackaging into penicillin bottles, half-pressing, and preparing for freeze-drying.
The freeze-drying process is pre-freezing at-40 ℃ for 8 hours, primary drying at 0 ℃ for 20 hours, and secondary drying at 35 ℃ for 14 hours.
Example 6
Polyethylene glycol loxenapeptide 2.12g
Mannitol 15g
The water for injection is added to 500ml
The prescribed amount of mannitol was weighed and dissolved in 400ml of water for injection with stirring. Weighing polyethylene glycol lozenith in a prescription amount, slowly stirring to dissolve, adding a proper amount of acetic acid, adjusting the pH to 5, adopting water for injection to fix the volume of the solution to 500ml, finally filtering the liquid medicine by using a PES microporous filter membrane with the thickness of 0.22 mu m, subpackaging into penicillin bottles, half-pressing, and preparing for freeze-drying. The freeze-drying process is to pre-freeze at-45 ℃ for 6 hours, perform primary drying at 10 ℃ for 25 hours, perform secondary drying at 30 ℃ for 16 hours.
Claims (16)
1. A polyethylene glycol lozenges peptide pharmaceutical composition, which is characterized in that the pharmaceutical composition is a freeze-dried preparation, comprises polyethylene glycol lozenges peptide serving as an active ingredient, an excipient and a pH regulator;
wherein the weight ratio of the active ingredient to the excipient is 1:5-1:20, the excipient is sorbitol and dextran, and the weight ratio of the sorbitol to the dextran is 1:3-3:1.
2. The pharmaceutical composition according to claim 1, wherein the weight ratio of sorbitol to dextran is 1:3 to 1:1.
3. The pharmaceutical composition according to claim 1, wherein the weight ratio of active ingredient to excipient is 1:7 to 1:12.
4. The pharmaceutical composition of claim 1, wherein the lyophilized formulation has a moisture of 2.0% or less.
5. The pharmaceutical composition of claim 4, wherein the lyophilized formulation has a moisture of 0.5% to 1.0%.
6. The pharmaceutical composition according to claim 1 or 2, wherein the pH adjusting agent is acetic acid.
7. The pharmaceutical composition according to claim 1, wherein the active ingredient is present in an amount of 5% to 15% by weight.
8. The pharmaceutical composition of claim 7, wherein the active ingredient is present in an amount of 7% to 15% by weight.
9. The pharmaceutical composition according to claim 2, wherein the prescribed weight ratio of dextran is 40% to 70%.
10. The pharmaceutical composition of claim 9, wherein the prescribed weight ratio of dextran is 50% to 70%.
11. The pharmaceutical composition according to claim 2, wherein the weight ratio of the components of the pharmaceutical composition is as follows:
polyethylene glycol lobetade 1 part
2-3 parts of sorbitol
5-10 parts of dextran.
12. The pharmaceutical composition according to claim 11, wherein the weight ratio of the components of the pharmaceutical composition is as follows:
polyethylene glycol lobetade 1 part
Sorbitol 2.8 parts
8.5 parts of dextran;
or (b)
Polyethylene glycol lobetade 1 part
Sorbitol 2.8 parts
5.7 parts of dextran.
13. The pharmaceutical composition of claim 1, wherein the pH of the polyethylene glycol lozenithal pharmaceutical composition ranges from 4.0 to 6.0.
14. The pharmaceutical composition of claim 13, wherein the pH of the polyethylene glycol lozenithal pharmaceutical composition ranges from 5.0 to 5.5.
15. The pharmaceutical composition according to claim 1, wherein the preparation process thereof is as follows:
dissolving excipient with a prescription amount in 80% of water for injection by volume, and stirring and dissolving;
taking the polyethylene glycol lozenith with the prescription amount, adding the polyethylene glycol lozenith into the solution, stirring and dissolving, adding a proper amount of pH regulator, and regulating the pH to 4.0-6.0;
adding water for injection, and fixing the volume to 100% by volume;
filtering with 0.22 μm filter core, packaging, lyophilizing, tamponading, and capping to obtain polyethylene glycol lozenges peptide pharmaceutical composition.
16. The method for preparing polyethylene glycol lozenith peptide pharmaceutical composition according to claim 15, wherein the freeze-drying process is pre-freezing for 4-8 hours at-40 ℃ to-50 ℃, primary drying is carried out at 0 ℃ to 10 ℃ for 20-26 hours, and secondary drying is carried out at 25 ℃ to 35 ℃ for 10-20 hours.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201911165551.2A CN110732020B (en) | 2019-11-25 | 2019-11-25 | Stable pharmaceutical formulation containing polyethylene glycol lozenges |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201911165551.2A CN110732020B (en) | 2019-11-25 | 2019-11-25 | Stable pharmaceutical formulation containing polyethylene glycol lozenges |
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| CN110732020B true CN110732020B (en) | 2023-10-03 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105688191A (en) * | 2007-04-23 | 2016-06-22 | 精达制药公司 | Suspension formulations of insulinotropic peptides and uses thereof |
| CN107952064A (en) * | 2016-10-14 | 2018-04-24 | 江苏豪森药业集团有限公司 | Pharmaceutical preparation containing polyethylene glycol Luo Saina peptides and preparation method thereof |
| CN108606955A (en) * | 2016-12-09 | 2018-10-02 | 江苏豪森药业集团有限公司 | The Pharmaceutical composition and preparation method thereof of trainingization Xihai sea horse peptide |
-
2019
- 2019-11-25 CN CN201911165551.2A patent/CN110732020B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105688191A (en) * | 2007-04-23 | 2016-06-22 | 精达制药公司 | Suspension formulations of insulinotropic peptides and uses thereof |
| CN107952064A (en) * | 2016-10-14 | 2018-04-24 | 江苏豪森药业集团有限公司 | Pharmaceutical preparation containing polyethylene glycol Luo Saina peptides and preparation method thereof |
| CN108606955A (en) * | 2016-12-09 | 2018-10-02 | 江苏豪森药业集团有限公司 | The Pharmaceutical composition and preparation method thereof of trainingization Xihai sea horse peptide |
Non-Patent Citations (2)
| Title |
|---|
| Polyethylene glycol loxenatide injections added to metformin effectively improve glycemic control and exhibit favorable safety in type 2 diabetic patients;Xiaoping CHEN等;《Journal of Diabetes》;20170228;第9卷;第158-167页 * |
| 注射用长春西汀无菌粉末处方及工艺研究;李军等;《济宁医学院学报》;20050630;第28卷(第2期);第2-4页 * |
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