CN109276540A - For treating the liposomal paclitaxel formulation of bladder cancer - Google Patents
For treating the liposomal paclitaxel formulation of bladder cancer Download PDFInfo
- Publication number
- CN109276540A CN109276540A CN201710591112.2A CN201710591112A CN109276540A CN 109276540 A CN109276540 A CN 109276540A CN 201710591112 A CN201710591112 A CN 201710591112A CN 109276540 A CN109276540 A CN 109276540A
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- liposomal formulation
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- bladder
- bladder cancer
- taxol
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- 238000009472 formulation Methods 0.000 title claims abstract description 41
- 206010005003 Bladder cancer Diseases 0.000 title claims abstract description 23
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- 229910052697 platinum Inorganic materials 0.000 claims description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Substances [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 claims description 2
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- 150000003856 quaternary ammonium compounds Chemical class 0.000 description 1
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 description 1
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Classifications
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dispersion Chemistry (AREA)
- Gynecology & Obstetrics (AREA)
- Reproductive Health (AREA)
- Urology & Nephrology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses prepare Paclitaxel liposome preparation composition and its application method.Liposomal paclitaxel formulation is used together with bladder cancer with the therapeutic scheme of upper and lower bladder transitional cell carcinoma.Therefore, said preparation is suitable for treating bladder cancer, and treatment bladder transitional cell carcinoma by intravesical administration.Preparation according to the present invention includes taxol, (b) and (c).
Description
Technical field
Invention as described herein is related to the administration of Liposomal formulation, and the Liposomal formulation includes taxol, lecithin, gallbladder
Sterol, threonine and glucose are used to treat bladder cancer and upper urinary tract cancer.
Summary of the invention
The present invention relates to the purposes of Liposomal formulation, the Liposomal formulation includes taxol, lecithin, cholesterol, Soviet Union
Propylhomoserin and glucose (" Liposomal formulation of the invention "), to treat bladder cancer or upper bladder transitional cell carcinoma in the individual for needing it
(UTUC).Liposomal formulation of the invention usually passes through intravesical administration and is delivered to bladder；However, for Liposomal formulation to be passed
It is also applicable for sending the suitable retrograde or antegrade approach of supreme urinary tract and renal plevis in the method for the invention.
The form administration of Liposomal formulation of the invention to suspend in aqueous solution, such as saline solution or water.The present invention
For the Liposomal formulation of administration for treating bladder cancer, the general terms of bladder cancer include bladder, ureter, renal plevis and urothelium
Property kidney.Upper urothelium carcinogenesis is in upper urinary tract, the renal plevis including ureter and kidney.It is administered by means of the present invention
Liposomal formulation can also include one or more external pharmaceutically acceptable excipient added.Lipid system of the invention
Agent can also be used as a part administration of synergistic treatment, and synergistic treatment further comprises at least one treatment in addition to taxol
Drug.
Specific embodiment
The present invention relates to the methods for using Liposomal formulation, to treat bladder cancer or upper bladder transitional cell carcinoma, the liposome
Preparation includes taxol, lecithin, cholesterol, threonine and glucose (" Liposomal formulation of the invention ").Side of the invention
The Commercial examples of Liposomal formulation used in method are entitled
The Liposomal formulation of therapeutic dose is usually delivered medicine to wing by delivering in bladder by application method according to the present invention
Guang.Intravesical therapies include that therapeutic agent is directly perfused in bladder by the urethral catheter of insertion.In the typical case side of irrigation of bladder
In case, sterile catheter can be used straight or thick (male) conduit and carry out.Bladder is emptied completely.Catheter tip note can be inserted
Emitter (adapter including handling injector tip), overflows or is splashed during insertion to prevent.Alternatively, being connected to drug vial
Initiation pipe can be inserted in conduit, and pass through each gravity stream or mild injection perfusion chemotherapeutant.It can remove
Syringe or apothecary jar used in conduit system simultaneously keep pipeline intact.Conduit is squeezed and is closed, it is then stifled with sterile gauze
Plug takes out, to help to absorb any drop.If solution cannot be maintained at wing by the patient for receiving the Liposomal formulation of administration
In Guang, then not sharp catheter (Foley catheter) can be used, and catheter stopper can be inserted into conduit after the priming
End so that Liposomal formulation retains a certain amount of time in bladder, usually one to two hours, but if shorter
Period is that treatment is effective, then retention time is less.It can indicate that patient lies down and periodically relocates to drive from conduit
Bubble removing simultaneously ensures that drug is contacted with all areas of bladder.It, can be desired according to the mobility (mobility) of patient
Conduit is removed at the end of residence time, or by urinary drainage bag in patient's connection chemotherapeutant is discharged.In following United States Patent (USP)
The example of intravesical drug delivery apparatus and the method for being deployed to these devices in bladder is described during application is open:
US20150165178、US2012/0203203、US2012/0089122、US2012/0089121、US2011/0218488、
US2011/0202036、US 2011/0152839、US2011/0060309、US2010/0331770、US2010/0330149、
US2010/0003297, US2009/0149833 and US2007/0202151, are fully incorporated herein.
The Liposomal formulation of therapeutic dose is delivered medicine to upper urinary tract, including kidney by other application methods according to the present invention
Renal plevis.Various methods can be used, Liposomal formulation is delivered to upper urinary tract, including the stent-type devices with balloon portion,
It is located in bladder, and after device is deployed in bladder, the liquid suspension equipped with Liposomal formulation of the invention.
Other than delivering in bladder, suitable conduit or kidney stoma into ureter known in the art can be used
Preparation and dosage form of the invention are administered into ureter and/or renal plevis by art conduit device and scheme.Chemotherapeutant this
Kind delivering can be used for treating, such as upper bladder transitional cell carcinoma.
In general, regardless of whether method of the invention by Liposomal formulation is delivered to bladder, upper urinary tract or renal plevis, before administration
Liposomal formulation is suspended in aqueous solution.For example, Liposomal formulation can suspend in water, preferably sterile water or sterile distillation
Water.Alternatively, Liposomal formulation can be suspended in sterile saline solution, preferably 0.9% NaCl saline solution.Pharmaceutically may be used
The buffer solution of receiving, such as phosphate buffered saline (PBS) (PBS) is also for suspending liposomes preparation in the method for the invention
Suitably.
As described above, method administration Liposomal formulation of the invention is to treat bladder cancer or upper bladder transitional cell carcinoma (UTUC).
In fact, treating various types of kidney neoplasms and bladder transitional cell carcinoma by means of the present invention, including non-Myometrial involvement bladder
Cancer (NMIBC), squamous cell carcinoma, gland cancer and bladder transitional cell carcinoma, also referred to as transitional cell carcinoma.Bladder transitional cell carcinoma be bladder cancer most
Common type accounts for bladder cancer all cases about 90% or so.In about 75% case, these cancers are usually surface layer,
Wherein they not yet enter the deeper of the bladder wall.Term " upper bladder transitional cell carcinoma " typically refers to the kidney neoplasms occurred in upper urinary tract
And bladder transitional cell carcinoma.
The therapeutic dose of invented liposomes preparation generally comprises a certain amount of taxol, with bladder cancer or UTUC
In individual, the amount of taxol is enough to eliminate all symptoms or at least partly mitigates at least one of bladder cancer or UTUC symptom disease
Shape.Specific treatment effective dose depends on stage, severity and the process of bladder cancer, previous treatment, individual health
Situation, weight, to the reaction of drug and/or the judgement for the treatment of physician.Exemplary treatment dosage for the method for the present invention includes
1-1000mg/m2The taxol of amount.For example, therapeutic dose can be 1-100mg/m2、50-150mg/m2、100-200mg/m2、
150-250mg/m2、200-300mg/m2、350-450mg/m2、400-500mg/m2、450-550mg/m2、500-600mg/m2、
550-650mg/m2、600-700mg/m2、750-850mg/m2、800-900mg/m2、850-950mg/m2、900-1000mg/m2
Or 950-1000mg/m2。
The Liposomal formulation that at least one pharmaceutically suitable excipient has been added can also be administered in method of the invention.Example
Such as, freeze-dried lipidosome preparation according to the present invention can be mixed at least one pharmaceutically acceptable excipient.Illustratively
Pharmaceutically acceptable excipient includes but is not limited to: (a) cryoprotector, filler or additive, for example, mannitol, starch,
Lactose (such as lactose monohydrate), sucrose, glucose, trehalose and silicic acid；(b) adhesive, such as cellulose derivative, packet
Include hydroxypropyl methyl cellulose (trade name BenecelTM), hydroxypropyl cellulose (trade name KlucelTM
(AshlandInc-Covington, KY)), starch, alginate, gelatin, polyvinylpyrrolidone, sucrose and Arabic gum；
(c) sorbefacient, such as quaternary ammonium compound.
In some cases, method of the invention is suitble to that another therapeutic agent is administered, as treatment bladder cancer or UTUC
A part of synergistic treatment.For example, in certain synergistic treatments for the treatment of bladder cancer or UTUC, except Liposomal formulation of the invention
Outside, 5 FU 5 fluorouracil (5-FU) or cis-platinum is also administered.Using be treated in combination in the case where, other medicaments need not with liposome
The identical pharmaceutical composition administration of preparation, and due to different physics and chemical characteristic, it can be given by different approach
Medicine.It, can be simultaneously according to the stage and type of bladder cancer or UTUC, the situation of patient and the actual selection of compound used therefor
(for example, simultaneously, substantially simultaneously or in identical therapeutic scheme) or other therapeutic agent is successively administered.Can based on to
The disease for the treatment of and the assessment of individual state determine the order of administration and number of repetition of every kind of therapeutic agent in therapeutic scheme.
Claims (17)
1. the purposes of Liposomal formulation, the Liposomal formulation includes taxol, lecithin, cholesterol, threonine and glucose,
The Liposomal formulation is used to treat bladder cancer or upper bladder transitional cell carcinoma in the individual for needing it.
2. purposes according to claim 1, wherein the Liposomal formulation passes through delivering administration in bladder.
3. purposes according to claim 2, wherein the Liposomal formulation suspends in aqueous solution before administration.
4. purposes according to claim 3, wherein the aqueous solution is saline solution or water.
5. purposes according to claim 2, wherein the Liposomal formulation treats bladder cancer.
6. purposes according to claim 5, wherein bladder cancer is non-Myometrial involvement bladder cancer.
7. purposes according to claim 1, wherein the Liposomal formulation is delivered medicine to ureter or renal plevis or ureter
With in both renal plevis.
8. purposes according to claim 7, wherein the Liposomal formulation treats upper bladder transitional cell carcinoma.
9. purposes according to claim 8, wherein the Liposomal formulation suspends in aqueous solution before administration.
10. purposes according to claim 9, wherein the aqueous solution is saline solution or water.
11. purposes according to claim 1 to 10, wherein the dosage of the taxol is 135-175mg/m2。
12. purposes according to claim 1 to 10, wherein the Liposomal formulation also includes at least one medicine
Acceptable excipient on.
13. purposes according to claim 12, wherein the dosage of the taxol is 1-1000mg/m2。
14. purposes according to claim 1 to 10, wherein the Liposomal formulation as synergistic treatment one
Local administration, the synergistic treatment include at least one therapeutic agent in addition to taxol.
15. purposes according to claim 14, the other chemotherapeutic agent of wherein at least one is cis-platinum.
16. purposes according to claim 14, wherein the Liposomal formulation also includes at least one pharmaceutically acceptable
Excipient.
17. purposes according to claim 14, wherein the dosage of the taxol is 1-1000mg/m2。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201710591112.2A CN109276540A (en) | 2017-07-19 | 2017-07-19 | For treating the liposomal paclitaxel formulation of bladder cancer |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710591112.2A CN109276540A (en) | 2017-07-19 | 2017-07-19 | For treating the liposomal paclitaxel formulation of bladder cancer |
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| CN201710591112.2A Pending CN109276540A (en) | 2017-07-19 | 2017-07-19 | For treating the liposomal paclitaxel formulation of bladder cancer |
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| Country | Link |
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2017
- 2017-07-19 CN CN201710591112.2A patent/CN109276540A/en active Pending
Non-Patent Citations (2)
| Title |
|---|
| 南京绿叶制药有限公司: "注射用紫杉醇脂质体说明书", 《注射用紫杉醇脂质体说明书》 * |
| 王兴文: "《肿瘤诊疗思路与临床实践》", 30 June 2016 * |
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