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Controlled Delivery Drug Synthesis Containing Erythromycin Subsidiaries And Making Of The Same

Abstract: Abstract of the Invention Controlled Delivery Drug Svthesis Containing Erythromycin Subsidiaries and making of the The present patent specification relates to pharmaceutical compositions for controlled release of an erythromycin derivative in the gastrointestinal environment, comprising a polymer that can be used in medicine and a derivative of erythromycin. While maintaining . bioavailability and a minimum concentration substantially equivalent to that of the immediate release composition upon multiple dosing, the compositions induce statistically significantly lower maximum concentrations (Cmax) of the erythromycin derivative in plasma than controlled release compositions. The compositions have less gastrointestinal side effects and a better taste profile.

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Patent Information

Application #
Filing Date
15 June 2023
Publication Number
28/2023
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application

Applicants

CONSERN PHARMA LIMITED
308-C, BHAI RANDHIR SINGH NAGAR LUDHIANA PUNJAB-141012 INDIA

Inventors

1. KULJIVE MAHAJAN
308-C, BHAI RANDHIR SINGH NAGAR LUDHIANA PUNJAB-141012 INDIA
2. SEEMA MAHAJAN
308-C, BHAI RANDHIR SINGH NAGAR LUDHIANA PUNJAB-141012 INDIA

Specification

FIELD OF THE INVENTION: The invention relates to pharmaceutical formulations of erythromycin derivatives .that have an extended release of an active compound in the gastrointestinal environment Specifically, the invention is directed to compositions containing with drug structures of clarithromycin which are ingested day to day as a solitary oral organization. BACKGROUND OF THE INVENTION: ERY is a macrolide compound that has an expansive scope of antimicrobial movement and is utilized to treat different bacterial contaminations influencing various pieces of the body. ERY's effectiveness against drug-resistant pathogens has been widely used since its discovery in 1952, but it has several limitations that pose significant clinical challenges. These limitations include drug resistance and undesirable effects at higher doses, as well as low solubility in water, instability under acidic conditions, limited efficacy, and bioavailability. Over the past few decades, various formulations of ERY, including nanoparticles, have been developed by researchers to overcome these disadvantages. However, despite the growing interest in these ERY formulations, no in-depth analysis of their features exists. As a result, the purpose of this review is to examine the efforts made to encapsulate ERY in formulations of various sizes, morphologies, and chemical compositions, as well as their physicochemical properties and outcomes. Additionally, the review addresses these studies' limitations, such as the quantification of ERY. According to the literature, a wide variety of vesicular systems are utilized for drug delivery. · These systems include, but are not limited to, lipid particles, liposomes, niosomes, sphingo~omes, pharmacosomes, transferosomes, and polymeric micelles. These vesicular carriers are primarily designed to solve issues with drug delivery and improve therapeutic outcomes. A few benefits of utilizing lipid-based drug conveyance incorporate the capacity to typify both hydrophilic and lipophilic medications, further developed bioavailability, broadened drug course time, decrease of poisonousness, and diminished remedial dose prerequisites. 2 Erythromycin and its derivatives are typically administered as immediate release (IR) formulations two to three times per day for 10 to 14 days. They have potent antibacterial activity against a variety of organisms. However, their sour taste, especially in the case of 6- 0-methoxyerythromycin A (clarithromycin), can make patients less likely to take their medications and may prompt the use of less efficient therapeutic options. Controlled release solid preparations containing erythromycin derivatives in an alginate matrix have been developed as one method for increasing compliance. Alginates and other monolithic hydrogel tablets, on the other hand, were found to be unsuitable for reproducibly bioavailable controlled release formulations in in vivo animal studies. Improved controlled · release formulations with a citric acid matrix and a poorly soluble basic drug have been developed to address this issue. The goal of these once-daily formulations is to achieve bioequivalence with the current twice-daily IR formulations by increasing bioavailability. However, they· do not address the negative effects of taste perversion or gastrointestinal (GI} disorders. To handle the last option issue, acceptable fluid oral measurement types of these medications have been grown, yet they actually require two times day to day organization and don't limit the antagonistic impacts connected with Gl problems·; As a result, a pharmaceutical composition that is equivalent to or better than the current IR tablet or liquid formulations in terms of minimizing side effects and controlling drug plasma concentration must be developed. Summary of the invention: The present invention relates to a pharmaceutical composition that a wide variety of vesicular systems are utilized for drug delivery. These systems include, but are not limited to, lipid particles, liposomes, niosomes, sphingosomes, pharmacosomes, transferosomes, and polymeric micelles. These vesicular carriers are primarily designed to solve issues with drug delivery and improve therapeutic outcomes. A few benefits of utilizing lipid-based drug conveyance incorporate the capacity to typify both hydrophilic and lipophilic medications, further developed bioavailability, broadened drug course time, decrease of poisonousness, and diminished remedial dose prerequisites. 3 Erythromycin and its derivatives are typically administered as immediate release (IR) formu.lations two to three times per day for 10 to 14 days. They have potent antibacterial activity against a variety of organisms. However, their sour taste, especially in the case of 6- 0-methoxyerythromycin A (clarithromycin), can make patients less likely to take their medications .and may prompt the use of less efficient therapeutic options. Controlled release solid preparations containing erythromycin derivatives in an alginate matrix have been developed as one method for increasing compliance. Alginates and other monolithic hydrogel tablets, on the other hand, were found to be unsuitable for reproducibly bioavailable controlled release formulations in in vivo animal studies. Improved controlled release formulations with a citric acid matrix and a poorly soluble basic drug have been developed to address this issue. The goal of these once-daily formulations is to achieve bioequivalence with the current twice-daily IR formulations by increasing bioavailability. However, they do not address the negative effects of taste perversion or gastrointestinal (GI) disorders. To handle the last option issue, acceptable fluid oral measurement types of these medications have been grown, yet they actually require two times day to day organization and don't limit the antagonistic impacts connected with Gl problems. As a result, a pharmaceutical composition that is equivalent to or better than the current IR tablet or liquid formulations in terms of minimizing side effects and controlling drug plasma concentration must be developed. ; A controlled-release pharmaceutical composition for the treatment of bacterial infections in mammals is provided by the present invention in another embodiment. A pharmaceutically acceptable polymer and a derivative of erythromycin

Documents

Application Documents

# Name Date
1 202311040700-Other Patent Document-150623.pdf 2023-06-21
2 202311040700-Form-9-150623.pdf 2023-06-21
3 202311040700-Form-5-150623.pdf 2023-06-21
4 202311040700-Form-3-150623.pdf 2023-06-21
5 202311040700-Form-2-150623.pdf 2023-06-21
6 202311040700-Form-18-150623.pdf 2023-06-21
7 202311040700-Form-1-150623.pdf 2023-06-21
8 202311040700-FER.pdf 2024-06-11
9 202311040700-Others-280824.pdf 2024-08-30
10 202311040700-Form 2-280824.pdf 2024-08-30
11 202311040700-FER-SER-REPLY-280824.pdf 2024-08-30
12 202311040700-Description (Complete)-280824.pdf 2024-08-30
13 202311040700-Correspondence-280824.pdf 2024-08-30
14 202311040700-Claims-280824.pdf 2024-08-30
15 202311040700-Abstract-280824.pdf 2024-08-30
16 202311040700-US(14)-HearingNotice-(HearingDate-23-10-2024).pdf 2024-09-23
17 202311040700-Others-231024.pdf 2024-10-29
18 202311040700-Others-231024-1.pdf 2024-10-29
19 202311040700-Form 5-231024.pdf 2024-10-29
20 202311040700-Form 2-231024.pdf 2024-10-29
21 202311040700-Description (Complete)-231024.pdf 2024-10-29
22 202311040700-Correspondence-231024.pdf 2024-10-29
23 202311040700-Claims-231024.pdf 2024-10-29
24 202311040700-Abstract-231024.pdf 2024-10-29
25 202311040700-Form 2-111124.pdf 2024-11-13
26 202311040700-FER SER REPLY-111124.pdf 2024-11-13
27 202311040700-Description (Complete)-111124.pdf 2024-11-13
28 202311040700-Claims-111124.pdf 2024-11-13
29 202311040700-Abstract-111124.pdf 2024-11-13
30 202311040700-US(14)-HearingNotice-(HearingDate-03-01-2025).pdf 2024-12-06

Search Strategy

1 SearchHistoryE_10-06-2024.pdf