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Formulations containing domperidone

A technology for domperidone and preparations, applied in the field of preparations containing domperidone, can solve the problems of limited accessibility of cisapride, easy loss of efficacy of erythromycin, adverse interaction and the like

Pending Publication Date: 2021-06-15
CINDOME PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Metoclopramide causes serious side effects such as dyskinesias or adverse interactions with other drugs; erythromycin tends to lose efficacy as patients develop resistance; and cisapride has limited access

Method used

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  • Formulations containing domperidone
  • Formulations containing domperidone
  • Formulations containing domperidone

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Embodiment 1: formulation preparation

[0067] By combining the components indicated in Table 1, five formulations containing domperidone, A-E, were prepared.

[0068]

[0069] Formulations A-C and E were formulated as liquids or semi-solids and filled into capsules, Formulation D was compressed using a single station carver press to form tablets.

Embodiment 2

[0071] Domperidone pharmaceutical formulations were prepared and encapsulated on a GMP encapsulation machine using the quantities noted in Tables 2-4. Specifically, batching activities were performed under a nitrogen blanket and yellow light. The batch was then encapsulated using a 2C oval mold and a 0.040" hole single bottom shot wedge at a temperature of about 38.7 to 51.7°C. The capsules were filled with a medium chain triglyceride / lecithin mixture ( 97% MCT / 3% lecithin) hand polished.

[0072]

[0073]

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PUM

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Abstract

The disclosure provides pharmaceutical formulations comprising domperidone or a pharmaceutically acceptable salt thereof. The formulations also contain (i) a glyceryl stearate, and a medium chain triglyceride; or (ii) a stearoyl polyoxyl glyceride, a nonionic poly(ethylene oxide) polymer, and a medium chain triglyceride; or (iii) a nonionic poly(ethylene oxide) polymer, and a polyethylene glycol. The disclosure also provides methods for treating a disorder that is gastroparesis, nausea apart from gastroparesis, vomiting apart from gastroparesis, nausea associated with gastroparesis, vomiting associated with gastroparesis, gastroesophageal reflux disease, insufficient lactation, or a combination thereof in a patient, comprising administering to the patient a formulation described herein. In some aspects, the disorder is gastroparesis. In other aspects, the disorder is gastroesophageal reflux disease. In further aspects, the disorder is insufficient lactation.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 750,480, filed October 25, 2018, the disclosure of which is incorporated herein by reference. technical field [0003] The present disclosure relates to pharmaceutical formulations containing domperidone. Background technique [0004] Gastroparesis is a condition in which the motility of the stomach does not work or does not work properly, which prevents the stomach from emptying and interferes with digestion. Treatment for gastroparesis requires drugs such as metoclopramide, erythromycin, or cisapride to stimulate the stomach muscles. Metoclopramide causes serious side effects, such as dyskinesia or adverse interactions with other drugs; erythromycin tends to lose efficacy as patients develop drug resistance; and cisapride has limited access. [0005] Drugs that control nausea and vomiting, such as prochlorperazine, thietherazine, diph...

Claims

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Application Information

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IPC IPC(8): A61K31/454A61P1/08
CPCA61K31/454A61P1/08A61K9/4858A61K9/2031A61K9/4866A61P1/04A61K47/10A61K47/14A61K9/2013A61K9/10A61K31/4439
Inventor 皮约什·帕特尔凯瑟琳·皮尔斯乔纳森·伊萨克松
Owner CINDOME PHARMA INC
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