Liquid formulation compositions, medicament delivery devices, and methods of preparation and use thereof

a technology of liquid formulation and medicament, which is applied in the direction of pharmaceutical containers, packaging foodstuffs, packaged goods, etc., can solve the problems of affecting the development of effective products, affecting the effect of drug safety, and affecting the safety of patients, etc., and achieves the effect of short tim

Inactive Publication Date: 2020-08-20
SHENZHEN HIGHTIDE BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0022]Technical problem to be solved by the invention includes providing compositions and medicament delivery devices, and methods for preparing and using the same, which can effectively treat ear congestion, nasal congestion, pain, cough, asthma, dry eyes, dry mouth, dry nose and other discomfortable diseases and conditions in a short time.

Problems solved by technology

There were, however, various problems emerged in developing effective products.
For example, although a nasal wash product prepared by utilizing synthetic surfactants as ingredients could help the patient clear away mucus in nasal cavity and reduce nasal congestion symptom effectively, the ingredients in the product caused some patients to lose their sense of smell, which resulted a voluntary recall of the product from the market (NeilMed's SinuSurf Additive Causes Loss of Sense of Smell, http: / / www.texassinuscenter.com, accessed on Jul. 30, 2014).
The pulmonary surfactant used in the study was expensive, and a nebulizer is complex and inconvenient to use in many settings.
Meanwhile, the propellant may cause irritation to the nasal cavity with local inflammation.

Method used

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  • Liquid formulation compositions, medicament delivery devices, and methods of preparation and use thereof

Examples

Experimental program
Comparison scheme
Effect test

example i

[0310]The exemplary embodiment describes a formulation and a preparation method thereof disclosed herein.

[0311]2.38 g of hydrogenated phospholipid, 0.12 g of sterol, 0.4 g of methyl paraben, 0.2 g of ethyl paraben and 0.1 g of menthol were weighed and placed in a beaker. 1 mL of anhydrous ethanol was added and dissolved with ultrasonic (40 KHz). While mixing at a high-speed stirring (6000 rpm), water was continuously added till the final volume of 100 mL, and mixed well. The formulation was filled into a containment vessel, such as sprayer or a dropping device, and the containment vessel was sealed. After the results of appearance, volume, content of main ingredient, weight per spray (or weight per drop), microbial limit and other tests were found to meet the requirements, outside packaging was performed to obtain the final product.

[0312]The surface tension of a final product was tested to be 48.851 mN / m by an automatic surface tensionmeter (US Kino, A601). The particle size distrib...

example ii

[0314]The exemplary embodiment describes a formulation and a preparation method thereof disclosed herein.

[0315]2.35 g of soya lecithin, 0.15 g of poloxamer, 0.08 g of vitamin E and 0.5 g of phenylethanol were weighed and placed in a beaker. 1 mL of anhydrous ethanol was added and dissolved with ultrasonic (40 KHz). While mixing at high speed (6000 rpm), water was continuously added till the final volume of 100 mL, and mixed well. The formulation was filled into a containment vessel, such as sprayer or a dropping device and the containment vessel was sealed. After the results of appearance, volume, content of main ingredient, weight per spray (or weight per drop), microbial limit and other tests were found to meet the requirements, outside packaging was performed for preparation to obtain the final product.

[0316]The surface tension of a final product was tested to be 16.252 mN / m by an automatic surface tensionmeter (US Kino, A601). The particle size distribution of the product was de...

example iii

[0318]The exemplary embodiment describes a formulation and a preparation method thereof disclosed herein.

[0319]3.75 g of soya lecithin and 0.64 g of vitamin E were weighed and placed in a beaker. 1 mL of anhydrous ethanol was added and dissolved with ultrasonic (40 KHz). The ethanol solution was added into 0.05 g of lauric acid monoglyceride and 99 mL of Tris-citric acid buffer solution with the pH in the range of 6.0-7.4 while a high-speed stirring (6000 rpm). The ultrasonic homogenization was further performed in an ultrasonic homogenizer. Then, the formulation was filled into containment vessel, such as an anti-contamination medicine delivery device (OSD) and sealed. After the results of appearance, volume, content of main ingredient, weight per spray (or weight per drop), microbial limit and other tests were found to meet the requirements, outside packaging was performed to obtain the final product.

[0320]The surface tension of a final product was tested to be 26.225 mN / m by an a...

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Abstract

The invention provides liquid formulation compositions and medicament delivery devices, and methods for preparing and using the same. For example, the liquid formulation composition is an emulsion including a solvent and liquid particles, which includes surfactants and are dispersed in the solvent. The volume average particle size of the liquid particles is less than about 100 μm; the surface tension of the liquid formulation composition is less than about 60 mN / m; and the absolute value of zeta potential is greater than about 15 mV. The containment vessel may be a sprayer or a dropping device. The invention also provides methods for preparation of the liquid formulation compositions and medicament delivery devices as well as methods for using the same in treatment of various diseases and condition, for example, otitis media, otitis externa, rhinitis, sinusitis, lower respiratory tract inflammation, xerostomia (dry mouth), xerophthalmia (dry eyes) and xeromycteria (dry nose).

Description

PRIORITY CLAIMS AND RELATED APPLICATIONS[0001]This application claims the benefit of Chinese Application Nos. CN201410390825.9, CN201410391082.7, CN201410391083.1 and CN201410391084.6, all filed Aug. 8, 2014, the entire content of each of which is incorporated herein by reference in its entirety.TECHNICAL FIELD OF THE INVENTION[0002]The invention relates to liquid formulation compositions and medicament delivery devices, and methods for preparing and using the same.BACKGROUND OF THE INVENTION[0003]Otitis media, otitis externa, rhinitis and sinusitis are the most commonly occurred otorhinolaryngologic diseases.[0004]Otitis media is an inflammatory lesion involving all or part of the structure of middle ear (including Eustachian tube, tympanic cavity, tympanic sinus and mastoid air cells) and are more common in children, but can occur at any age. There are two major types of otitis media, namely acute otitis media and otitis media with effusion. The former is usually symptomatic, espe...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/573A61K47/24A61K47/28A61K9/00A61K31/74A61K47/32A61K47/10A61K31/5383A61K9/16A61M11/00A61K9/107
CPCA61K47/28A61J1/05A61K47/32A61K9/1617A61M2210/0618A61K47/24A61M11/00A61M2210/0668A61K31/5383A61M2210/0612A61K47/10A61K9/0048A61K31/573A61K31/74A61K9/0043A61M2202/04A61M2210/0662A61K9/0046A61K9/1641A61K9/107A61P1/02A61P11/00A61P11/02A61P11/12A61P27/04A61P27/16A61K9/08A61P27/02
Inventor YU, LIFERGUSON, JAMES GERRY
Owner SHENZHEN HIGHTIDE BIOPHARM
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