Nasal spray pharmaceutical formulation for treating nasal bacterial infections, comprises e.g. amoxicillin, clavulanate, chitosan, polyvinyl alcohol, ethylenediaminetetraacetic acid, polyoxyethylene 20 sorbitan monooleate, poloxamer 407, crosslinked acrylic acid polymer, xanthan gum, glycerin,
	PRAKASH B D; NARAYANA L R; CHITYALA M; AMBATI S R
	2023-12-29
专利权人	AODH LIFESCIENCES PRIVATE LTD (AODH-Non-standard)
申请日期	2023-12-29
专利号	IN202341047811-A
成果简介	NOVELTY - Nasal spray pharmaceutical formulation comprises 0.001-4.87 wt. vol.% amoxicillin, 0.001-2.13 wt. vol.% clavulanate, 0.5-2 wt. vol.% chitosan, 0.5-2 wt. vol.% polyvinyl alcohol, 0.1-0.5 wt. vol.% ethylenediaminetetraacetic acid (EDTA), 0.1-1 wt. vol.% Polysorbate(RTM: Polyoxyethylene 20 sorbitan monooleate) 80, 1-2 wt. vol.% poloxamer 407, 0.1-1 wt. vol.% Carbopol (RTM: Crosslinked acrylic acid polymer), 0.1-0.5 wt. vol.% xanthan gum, 1-5 wt. vol.% glycerin, 0.05-0.1 wt. vol.% citric acid, purified water quantity sufficient (q.s.) to 100%. USE - Nasal spray pharmaceutical formulation for treating nasal bacterial infections, and treating post-surgical nasal infection such as sinusitis, rhinitis, rhinosinusitis, nasal vestibulitis, furunculosis, and septal abscess (all claimed). No biological data given. ADVANTAGE - The nasal spray pharmaceutical formulation is stable for at least 12 months at 25℃ and 60% relative humidity, utilizes mucoadhesive polymer chitosan that enhances drug retention in the nasal cavity upon administration, has a viscosity of 1,000-3,000 cps, ensuring optimal deposition in the nasal cavity, disrupts bacterial biofilms in the sinus cavity through the combined action of amoxicillin, clavulanate, and chitosan. The nasal spray pharmaceutical formulation is dispensed as droplets with a particle size of 10-20 µm, suitable for effective nasal deposition and sinus penetration, is an aqueous suspension suitable for targeted drug release at the sinus infection site, utilizes poloxamer 407 and Carbopol (RTM: Crosslinked acrylic acid polymer) that enables sustained release of the active pharmaceutical ingredients for a duration of 8-24 hours, utilizes mucoadhesive polymer chitosan that increases the residence time of the formulation in the nasal cavity by at least 30% compared to a nonmucoadhesive formulation, utilizes the combination of amoxicillin, clavulanate, and chitosan that disrupts bacteria biofilms by penetrating the biofilm matrix and inhibiting bacterial adhesion within the sinus cavities. The nasal spray pharmaceutical formulation provides effective local drug delivery, minimizing systemic side effects, and improving patient compliance. DETAILED DESCRIPTION - INDEPENDENT CLAIMS are included for: 1. a method for treating a post-surgical nasal infection in a human or animal, comprising: (a) providing an aqueous pharmaceutical suspension comprising 0.001-4.87 wt. vol.% amoxicillin, 0.001-2.13 wt. vol.% clavulanate, chitosan, polyvinyl alcohol, EDTA, Polysorbate(RTM: Polyoxyethylene 20 sorbitan monooleate) 80, poloxamer 407, Carbopol (RTM: Crosslinked acrylic acid polymer), xanthan gum, glycerin, and citric acid; (b) administering the suspension nasally to the subject in an amount effective to treat the post-surgical nasal infection; 2. a method for preparing nasal spray pharmaceutical formulation, comprising: (a1) providing a chitosan solution comprising chitosan dissolved in an aqueous acidic solution; (b1) providing a polymer solution comprising polyvinyl alcohol, poloxamer 407, Carbopol (RTM: Crosslinked acrylic acid polymer), and xanthan gum dissolved in water; (c1) providing a buffer solution comprising citric acid and EDTA dissolved in water, where the pH of the buffer solution is adjusted to 6.5-7.5; (d1) providing a surfactant solution comprising Polysorbate(RTM: Polyoxyethylene 20 sorbitan monooleate) 80 and glycerin dissolved in water; (e1) providing an active pharmaceutical ingredient (API) solution comprising amoxicillin and clavulanate potassium dissolved in the polymer solution; (f1) combining the chitosan solution, polymer solution, the buffer solution, and the surfactant solution with the API solution; (g1) homogenizing the combined solution using a high-shear homogenizer; (h1) filtering the homogenized solution through a 0.22 µm sterile filter; and (i1) filling the sterile filtered solution into metered-dose nasal spray devices; and 3. a kit comprising a container containing the composition, and instructions for use of the composition.
IPC 分类号	A61K-031/43
国家	印度
专业领域	医药卫生
语种	英语
成果类型	专利
文献类型	科技成果
条目标识符	http://119.78.100.226:8889/handle/3KE4DYBR/18583
专题	中国科学院新疆生态与地理研究所
作者单位	AODH LIFESCIENCES PRIVATE LTD (AODH-Non-standard)
推荐引用方式 GB/T 7714	PRAKASH B D,NARAYANA L R,CHITYALA M,et al. Nasal spray pharmaceutical formulation for treating nasal bacterial infections, comprises e.g. amoxicillin, clavulanate, chitosan, polyvinyl alcohol, ethylenediaminetetraacetic acid, polyoxyethylene 20 sorbitan monooleate, poloxamer 407, crosslinked acrylic acid polymer, xanthan gum, glycerin,. IN202341047811-A[P]. 2023.

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