IP Library Granted Patent US 10,195,139
Granted Patent B2
US 10,195,139 · App. 13/649,515 · Granted Feb 5, 2019

Preparation for transnasal application

Inventors: Ryoichi Nagata (Kagoshima, JP); Shunji Haruta (Kagoshima, JP)
Assignee: Shin Nippon Biomedical Laboratories, Ltd.
A61K9/0043A61K9/1611A61K9/1652A61K31/4045A61K31/4178A61K31/4375A61K31/4535A61K31/485A61K31/573A61K45/06A61K9/4866A61K38/00
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Quick Facts
Patent No.
US 10,195,139
App. No.
13/649,515
Granted
Feb 5, 2019
Kind
B2
Abstract

Disclosed is a preparation for transnasal application, which has improved fluidability. Specifically disclosed is a preparation for transnasal application, which comprises at least a complex comprising a fluidability-improving component comprising a first crystalline cellulose (A) having specified powder properties, tricalcium phosphate (B) having specified powder properties, and a second crystalline cellulose (C) having specified powder properties or a starch (D) having specified powder properties, and physiologically active substance.

Claims (28)

1. A method for manufacturing a set of vessels containing a powdery formulation for nasal administration, comprising:

filling a set of vessels with the powdery formulation comprising a drug, and a carrier that comprises 1) a first crystalline cellulose, 2) a second crystalline cellulose or a starch, and 3) tribasic calcium phosphate,

wherein the first crystalline cellulose has an angle of repose of 59° to 70°,

wherein the powdery formulation has an angle of repose of 40° to 53°, and

wherein the set of vessels has a smaller standard deviation in a filled amount by weight than a set of vessels filled with a corresponding powdery formulation without the carrier.

2. The method of claim 1 , wherein the second crystalline cellulose or the starch has an average particle diameter of 30 to 100 μm.

3. The method of claim 1 , wherein the tribasic calcium phosphate is present from 0.1 to 10 (W/W) % of the carrier.

4. The method of claim 1 , wherein the tribasic calcium phosphate has an average particle diameter of 100 μm or less.

5. The method of claim 1 , wherein the first crystalline cellulose is present from 60 to 94.9 (W/W) % of the carrier.

6. The method of claim 1 , wherein the second crystalline cellulose or the starch is present from 5.0 to 30 (W/W) % of the carrier.

7. The method of claim 3 , wherein the tribasic calcium phosphate is present from 0.5 to 5 (W/W) % of the carrier.

8. The method of claim 1 , wherein a ratio of the drug to the carrier is 0.0001 to 1.2:1, and wherein the ratio is calculated using weight of the drug as a free form.

9. The method of claim 1 , wherein the powdery formulation further comprises a pH adjustor, preservative, stabilizer, flavor, absorbefacient, or substance that captures a divalent calcium ion.

10. The method of claim 1 , wherein the drug is selected from the group consisting of morphine, fentanyl, oxycodone, butorphanol, tramadol, granisetron, ondansetron, tropisetron, palonosetron, indisetron, sumatriptan, zolmitriptan, rizatriptan, naratriptan, ergotamine, triazolam, melatonin, carbamazepine, midazolam, donepezil, tiapride, cefaclor, enoxacin, aciclovir, zidvudine, didanosine, nevirapine, indinavir, dantrolene, digoxin, trihexyphenidyl, biperiden, dextromethorphan, naloxone, betahistine, naphazoline, diltiazem, tranilast, loperamide, diclofenac, beclomethasone, chlorpheniramine, sildenafil, vardenafil, cyanocobalamin, finasteride, epinephrine, 5-fluorouracil, low-molecular-weight heparin, tacrolimus, RNA, RNAi, siRNA, and antisense DNA.

11. The method of claim 1 , wherein the drug is granisetron.

12. The method of claim 1 , wherein the drug is ondansetron.

13. The method of claim 1 , wherein the drug is morphine.

14. The method of claim 1 , wherein the drug is fentanyl.

15. The method of claim 1 , wherein the drug is oxycodone.

16. The method of claim 1 , wherein the drug is sumatriptan.

17. The method of claim 1 , wherein the drug is zolmitriptan.

18. The method of claim 1 , wherein the drug is beclometasone.

19. The method of claim 1 , wherein the drug is ketotifen.

20. The method of claim 1 , wherein the vessels are capsules.

21. The method of claim 1 , wherein the vessels are blister packs.

22. The method of claim 1 , wherein the first crystalline cellulose has an untapped bulk density of 0.13 to 0.29 g/cm 3 .

23. The method of claim 1 , wherein the first crystalline cellulose has an untapped bulk density of 0.21 to 0.28 g/cm 3 .

24. The method of claim 1 , wherein the second crystalline cellulose or the starch has an untapped bulk density of 0.26 to 0.48 g/cm 3 .

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 17, 2016
From: NAGATA, RYOICHI; HARUTA, SHUNJI
To: TRANSLATIONAL RESEARCH LTD.
Reel/Frame 040642/0194 →
CHANGE OF NAME Recorded Nov 17, 2016
From: TRANSLATIONAL RESEARCH LTD.
To: SHIN NIPPON BIOMEDICAL LABORATORIES, LTD
Reel/Frame 040642/0436 →
Priority Claims (1)
JP 2006-350094 · Dec 26, 2006 · national
Continuity (3)
Continuation 12521116
Related Publication 20130095145A1 · Apr 18, 2013
Related Publication 20150017212A9 · Jan 15, 2015
Cited By (2)
US 12,263,162 US 12,594,273