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Dispensing system

A technology for viscous solutions and analgesics, which can be applied to dispensing devices, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as limiting the accuracy of distribution

Inactive Publication Date: 2015-09-02
NUVO RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although guided by a specific area, it is not always easy for the user to cover a precise area each time, and its two-dimensional nature limits dispensing accuracy

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0036] The present invention provides methods and systems for administering topical substances. In some aspects, methods and systems use unpressurized systems. In one embodiment, the present invention provides a method for administering a recommended dose of a topical analgesic in a viscous solution comprising:

[0037] Start the hand pump as described in:

[0038] a) compressing the spring with the rod attached thereto, and the rod slides relative to the piston, and into a metering chamber containing a first predetermined amount of topical analgesic in a viscous solution;

[0039] b) opening the outlet valve of the metering chamber, which allows a first predetermined amount of the topical analgesic in the viscous solution to flow into the channel or opening of the rod; and

[0040] c) When the limiter of the tappet is connected with the limiter of the piston, the piston is impacted, wherein a predetermined amount of topical analgesic in a viscous solution is discharged thro...

Embodiment 1

[0132] Example 1 shows the performance evaluation of a 100 mL Rexam Sof' Bag bottle with a 1 mL dispensing pump for topical diclofenac sodium 2.0% w / w.

[0133] 1. Summary

[0134] This current study was completed to evaluate the dose delivery properties of Rexam Sof'Bag containers with metered pumps for topical diclofenac sodium gel 2.0% w / w. 16 containers were studied over a period of 1 month (16 working days). The results show that when filled to full capacity, the container can consistently deliver the desired number of doses with high precision. The average unit dose weight delivered from each container varied from 0.97-0.99 g, which was well within 5% of the target dose (1.00 g). The unit dose weight standard deviation was stable at 0.01 g per vial.

[0135] 2. Introduction

[0136] Diclofenac Sodium Topical Gel 2.0% w / w is a drug that is being investigated for the treatment of signs and symptoms of knee osteoarthritis.

[0137] According to the FDA guidance documen...

Embodiment 2

[0185] Example 2: Clinical pharmacokinetic analysis of 2.0% w / w diclofenac sodium topical viscous solution (multiple doses)

[0186] A topical viscous solution of 2.0% w / w diclofenac sodium of the present invention was topically applied to both knees (2 mL [40.4 mg] / knee) every 12±0.5 hours for 7.5 consecutive days under fed conditions. Individuals dispense the solution from Hand Pump A of Example 1 and apply the topical viscous solution to clean dry skin. To avoid spillage, dispense 2 mL (2 pumps) of the topical viscous solution first into the hands and then onto the knees. Apply the topical viscous solution evenly around the front, back and sides of the knee. On the other knee, repeat, making sure to apply until completely dry.

[0187] The following pharmacokinetic parameters of diclofenac sodium were determined:

[0188] Day 1: Maximum observed plasma concentration (C max ), reaching C max time (T max ), and the area under the plasma concentration curve (AUC) for the...

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Abstract

The invention provides systems and methods for controlled dispensing of topical analgesics contained in a metered dispensing system. The systems and method are useful for treating signs and symptoms of osteoarthritis. The method includes depressing a hand pump to dispense a dose of a topical pain reliever in a viscous solution from the hand pump, wherein the hand pump is configured to dispense the dose within a tolerance specified by a corresponding label approved by a government regulatory agency; and spreading the topical solution on skin.

Description

[0001] Cross References to Related Applications [0002] This application is U.S. Patent Application No. 13 / 657,711 filed October 22, 2012 field of invention [0003] The present invention relates to systems and methods for delivering topical drugs in metered doses. Background of the invention [0004] Topical analgesics are available in a number of dosage forms including solutions, liquids, foams, gels, creams, ointments, and the like. They are packaged in different container closure systems such as tubes, bottles, bags and cans. A common problem associated with many topical pain relief products is dispensing of inaccurate unit doses from multi-dose containers, which can leave patients under- or over-medicated. [0005] Dosing cards are a known method of measuring topical semi-solid medications. commercially available gel Anti-inflammatory drugs and rheumatic drugs are examples of using dose cards as the primary dose measurement method. The correct dose is assumed to ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B05B11/04A61M35/00G01F11/02B65D83/76F04B9/14A61J1/00
CPCA61M35/003A61K31/196A61K9/0014A61K9/06A61K9/08A61K47/38A61P19/02A61K47/10A61K47/20B05B11/04G01F11/02B65D83/00F04B9/14A61J1/00A61M35/00
Inventor T·德赛N·T-C·沃B·D·多提R·J·布伦德尔B·岳
Owner NUVO RES
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