WO2004089274A1 - Drug packaging, or kit, or presentation facilitating self administration of drugs by patients - Google Patents

Drug packaging, or kit, or presentation facilitating self administration of drugs by patients Download PDF

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Publication number
WO2004089274A1
WO2004089274A1 PCT/BR2004/000047 BR2004000047W WO2004089274A1 WO 2004089274 A1 WO2004089274 A1 WO 2004089274A1 BR 2004000047 W BR2004000047 W BR 2004000047W WO 2004089274 A1 WO2004089274 A1 WO 2004089274A1
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WIPO (PCT)
Prior art keywords
drugs
kit
drug
self administration
fact
Prior art date
Application number
PCT/BR2004/000047
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French (fr)
Inventor
Alexandre FUNARI NEGRÃO
Original Assignee
Medley S.A. Indústria Farmacêutica
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Filing date
Publication date
Application filed by Medley S.A. Indústria Farmacêutica filed Critical Medley S.A. Indústria Farmacêutica
Publication of WO2004089274A1 publication Critical patent/WO2004089274A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers

Definitions

  • the present invention refers to a drug packaging, or kit, or presentation of drugs that facilitates self administration by patients, applicable to the pharmaceutical industry, primarily intended for the treatment of people with problems related to gastroesophageal dysfunctions such as functional dyspepsia, associated with the gastroesophageal reflux disease, among others.
  • Functional dyspepsia is quite a common clinical condition, mostly characterized by epigastric pain in the absence of ulcerous lesions or other possibly related diseases. Other symptoms also present include abdominal discomfort or distention, reflux esophagitis, nausea, vomiting, and early satiation.
  • a drug packaging, or kit, or drug presentation facilitating self administration of drugs by patients has been developed, based on a treatment method for dyspeptic symptom incidence which consists of the administration to the patients of one or more prokinetic and/or antiemetic drugs, and of one or more gastric acid inhibitors, and other drugs well-known to those skilled in the art.
  • an improved functionality item i.e., a drug packaging, or kit, or drug presentation facilitating self administration of drugs by the patients, which is characterized by comprising one or more blister cards, cartridges, blisters, or the like, each one presenting one or more proton pump inhibitor (PPI) drug units, and one or more prokinetic and/or antiemetic drug units, or yet other drugs well-known to those skilled in the art, featuring patient instructions in print form with regard to the dosage of each unit, type or nature of the active ingredient, period of the day to be taken and treatment period, among other information, or according to FIGURE 1 or FIGURE 2 in annex.
  • PPI proton pump inhibitor
  • the gastric acid inhibitors or proton pump inhibitors are a class of anti- secretory compounds that suppresses gastric acid secretion by specific inhibition of the (H+, K+) ATPase enzyme system at the secretory surface of the gastric parietal cells.
  • the proton pump inhibitor (PPI) drugs used can be selected from the group containing: lansoprazole, omeprazole, pantoprazole, esomeprazole magnesium, rabeprazole sodium, among others, or their mixtures and combinations, in multiple dosages.
  • Lansoprazole is preferably used at the dosages of 15 mg or 30 mg.
  • the prokinetic and/or antiemetic drugs that can be used are selected from the group containing: bromopride, metoclopramide, domperidone, cisapride, alizapride hydrochloride, among others, or their mixtures and combinations, in multiple dosages, preferably that of 10 mg per drug unit. Particularly, bromopride is used at the unit dosage of 10 mg.
  • Bromopride is a prokinetic agent that also acts as an antiemetic agent by inhibiting the brain's vomiting center. Its therapeutic effect consists of normalizing stomach, duodenum and jejunum motility by restoring muscle tone and peristalsis to physiological standards
  • Unit of drug or drug unit implies tablets, pastilles, capsules, pills, or the like.
  • Each blister card, or cartridge, or blister, or the like features in a clear, instructive manner, instructions in print form about the drugs to be taken according to the time period, preferable of 7 days, identifying separately or individually per day, units to be administered or ingested at each period of the day, as for example: before breakfast, before lunch, and before dinner.
  • the drug packaging, or kit, or presentation facilitating self administration of the drugs by the patients contains enough drug units for 14, or 28 days, for a longer term treatment, comprising 2 or 4 blister cards, or cartridges, or blisters, or the like, each one presenting 7 proton pump inhibitor (PPI) drug units and 21 prokinetic and/or antiemetic drug units, didactically arranged so that the daily dosage be obeyed.
  • PPI proton pump inhibitor
  • lansoprazole is used as a proton pump inhibitors (PPI), at the dosages of 15 mg or 30 mg and bromopride as a prokinetic at the dosage of 10 mg.
  • FIGURES 1 and 2 in annex represent a possible model of the invention.
  • This comprises a blister card with drugs showing its front side (1) and its back side (2), which contain information in print form for a better orientation and utilization of these drugs by the patient, such as: - the names of the active ingredients involved: bromopride 10 mg (3) and lansoprazole 15 mg (4);
  • - treatment periodicity in this case for a week or 7 days; - it presents an individual distribution of drug units, indicating, horizontally, the units to be taken per day: 1 st day (5), 2 nd day (6), 3 rd day (7), 4 th day (8), 5 th day (9), 6 th day (10), and 7 th day (11); - it presents distinct columns, identified by different colors, indicating the drug units to be ingested:
  • the drug units are shown individualized and on the back side (2) instructions are shown, as composed in table below:
  • FIGURES 2 and 3 in annex represent another possible model of the invention.
  • This comprises a blister card with drugs showing its front side (1) and its back side (2), which contain information in print form for a better orientation and utilization of these drugs by the patient, such as:
  • the drug units are shown individualized and on the back side (2) instructions are shown, as composed on the table below:

Abstract

The present invention refers to a drug packaging, or kit, or presentation facilitating self administration of drugs by the patients, which is characterized by comprising one or more blister cards, cartridges, blisters, or the like, each one presenting one or more proton pump inhibitor (PPI) drug units, and one or more prokinetic and/or antiemetic drub units, or yet other drugs well-known to those skilled in the art, featuring patient instruction in print form with regard to the dosage of each unit, type or mature of the active ingredient, period of the day to be taken and treatment period, among other information.

Description

DRUG PACKAGING, OR KIT, OR PRESENTATION FACILITATING SELF ADMINISTRATION OF DRUGS BY PATIENTS.
The present invention refers to a drug packaging, or kit, or presentation of drugs that facilitates self administration by patients, applicable to the pharmaceutical industry, primarily intended for the treatment of people with problems related to gastroesophageal dysfunctions such as functional dyspepsia, associated with the gastroesophageal reflux disease, among others.
Functional dyspepsia is quite a common clinical condition, mostly characterized by epigastric pain in the absence of ulcerous lesions or other possibly related diseases. Other symptoms also present include abdominal discomfort or distention, reflux esophagitis, nausea, vomiting, and early satiation.
Intending to: • develop a presentation of the drugs in an instructive, functional and clear manner,
aiming to facilitate self administration of the drugs by the patients;
• reduce the final cost of the drugs to the patients;
a drug packaging, or kit, or drug presentation facilitating self administration of drugs by patients has been developed, based on a treatment method for dyspeptic symptom incidence which consists of the administration to the patients of one or more prokinetic and/or antiemetic drugs, and of one or more gastric acid inhibitors, and other drugs well-known to those skilled in the art.
More specifically, aiming to facilitate self administration of these drugs by individuals subjected to treatment, the Applicant has developed an improved functionality item, i.e., a drug packaging, or kit, or drug presentation facilitating self administration of drugs by the patients, which is characterized by comprising one or more blister cards, cartridges, blisters, or the like, each one presenting one or more proton pump inhibitor (PPI) drug units, and one or more prokinetic and/or antiemetic drug units, or yet other drugs well-known to those skilled in the art, featuring patient instructions in print form with regard to the dosage of each unit, type or nature of the active ingredient, period of the day to be taken and treatment period, among other information, or according to FIGURE 1 or FIGURE 2 in annex.
The gastric acid inhibitors or proton pump inhibitors (PPIs) are a class of anti- secretory compounds that suppresses gastric acid secretion by specific inhibition of the (H+, K+) ATPase enzyme system at the secretory surface of the gastric parietal cells. The proton pump inhibitor (PPI) drugs used can be selected from the group containing: lansoprazole, omeprazole, pantoprazole, esomeprazole magnesium, rabeprazole sodium, among others, or their mixtures and combinations, in multiple dosages. Lansoprazole is preferably used at the dosages of 15 mg or 30 mg.
The prokinetic and/or antiemetic drugs that can be used are selected from the group containing: bromopride, metoclopramide, domperidone, cisapride, alizapride hydrochloride, among others, or their mixtures and combinations, in multiple dosages, preferably that of 10 mg per drug unit. Particularly, bromopride is used at the unit dosage of 10 mg.
Bromopride is a prokinetic agent that also acts as an antiemetic agent by inhibiting the brain's vomiting center. Its therapeutic effect consists of normalizing stomach, duodenum and jejunum motility by restoring muscle tone and peristalsis to physiological standards
Unit of drug or drug unit implies tablets, pastilles, capsules, pills, or the like.
Each blister card, or cartridge, or blister, or the like, features in a clear, instructive manner, instructions in print form about the drugs to be taken according to the time period, preferable of 7 days, identifying separately or individually per day, units to be administered or ingested at each period of the day, as for example: before breakfast, before lunch, and before dinner.
In a preferred embodiment of the improved functionality item, the drug packaging, or kit, or presentation facilitating self administration of the drugs by the patients, contains enough drug units for 14, or 28 days, for a longer term treatment, comprising 2 or 4 blister cards, or cartridges, or blisters, or the like, each one presenting 7 proton pump inhibitor (PPI) drug units and 21 prokinetic and/or antiemetic drug units, didactically arranged so that the daily dosage be obeyed. Preferably, lansoprazole is used as a proton pump inhibitors (PPI), at the dosages of 15 mg or 30 mg and bromopride as a prokinetic at the dosage of 10 mg.
The examples that follows serve to better characterize the invention, nonetheless, these should not have an eventual limiting effects on the scope of the invention. EXAMPLE 1:
FIGURES 1 and 2 in annex represent a possible model of the invention. This comprises a blister card with drugs showing its front side (1) and its back side (2), which contain information in print form for a better orientation and utilization of these drugs by the patient, such as: - the names of the active ingredients involved: bromopride 10 mg (3) and lansoprazole 15 mg (4);
- product trade name or brand: Lansoprid 15
- manufacturer's name or brand: Medley
- treatment periodicity: in this case for a week or 7 days; - it presents an individual distribution of drug units, indicating, horizontally, the units to be taken per day: 1st day (5), 2nd day (6), 3rd day (7), 4th day (8), 5th day (9), 6th day (10), and 7th day (11); - it presents distinct columns, identified by different colors, indicating the drug units to be ingested:
. before breakfast (12); . before lunch (13); . before dinner (14). Totalizing a blister carton of 7 drug units of lansoprazole 15 mg and 21 drug units of bromopride 10 mg.
In the front side (1) of the blister card, cartridge, blister, or the like, the drug units are shown individualized and on the back side (2) instructions are shown, as composed in table below:
Figure imgf000006_0001
EXAMPLE 2:
FIGURES 2 and 3 in annex represent another possible model of the invention. This comprises a blister card with drugs showing its front side (1) and its back side (2), which contain information in print form for a better orientation and utilization of these drugs by the patient, such as:
- the names of the active ingredients involved: bromopride 10 mg (3) and lansoprazole 30 mg (4);
- product trade name or brand: Lansoprid 30
- manufacturer's name or brand: Medley - treatment periodicity: in this case for a week;
- it presents an individual distribution of drug units, indicating, horizontally, the units to be taken per day: 1st day (5), 2nd day (6), 3rd day (7), 4th day (8), 5th day (9), 6th day (10), and 7th day (11); it presents distinct columns, identified by different colors, indicating the drug units to be ingested:
. before breakfast (12); . before lunch (13);
. before dinner (14).
Totaling a blister carton of 7 drug units of lansoprazole 30 mg and 21 drug units of bromopride 10 mg.
In the front side (1) of the blister card, cartridge, blister, or the like, the drug units are shown individualized and on the back side (2) instructions are shown, as composed on the table below:
Figure imgf000008_0001

Claims

1. Drug packaging, or kit, or presentation facilitating self administration of drugs by the patients, which is characterized by comprising one or more blister cards, cartridges, blisters, or the like, each one presenting drug units comprising one or more proton pump inhibitor (PPI) drug units, and one or more prokinetic and/or antiemetic drug units, or yet other drugs well-known to those skilled in the art, featuring patient instructions in print form with regard to the dosage of each unit, type or nature of the active ingredient, period of the day to be taken and treatment period, among other information, or according to FIGURE 1 or FIGURE 2.
2. Drug packaging, or kit, or presentation facilitating self administration of drugs by the patients according to claim 1 characterized by the fact that the proton pump inhibitors (PPI's) that can be used are: lansoprazole, omeprazole, pantoprazole, esomeprazole magnesium, rabeprazole sodium, among others, or their mixtures and combinations.
3. Drug packaging, or kit, or presentation facilitating self administration of drugs by the patients according to claim 2 characterized by the fact that lansoprazole is preferably used.
4. Drug packaging, or kit, or presentation facilitating self administration of drugs by the patients according to claim 1 characterized by the fact that different dosages of each type of drug can be used.
5. Drug packaging, or kit, or presentation facilitating self administration of drugs by the patients according to claims 1, 2, and 3 characterized by the fact that lansoprazole is preferably used at the dosages of 15 mg or 30 mg.
6. Drug packaging, or kit, or presentation facilitating self administration of drugs by the patients according to claim 1 characterized by the fact that the drug units used can be: capsules, tablets, pastilles, pills, etc.
7. Drug packaging, or kit, or presentation facilitating self administration of drugs by the patients according to claim 1 characterized by the fact that the prokinetic and/or antiemetic drug that can be used is: bromopride, metoclopramide, domperidone, cisapride, alizapride hydrochloride, among others, or their mixtures and combinations.
8. Drug packaging, or kit, or presentation facilitating self administration of drugs by the patients according to claims 1 or 7 characterized by the fact that bromopride 10 mg is preferably used.
9. Drug packaging, or kit, or presentation facilitating self administration of drugs by the patients according to claim 1 characterized by the fact that each blister card, cartridge, blister, or the like, contains drugs for 7 days of treatment.
10. Drug packaging, or kit, or presentation facilitating self administration of drugs by the patients according to claim 1 characterized by the fact that it contains drugs for 14, or 28 days, or a longer term of treatment.
11. Drug packaging, or kit, or presentation facilitating self administration of drugs by the patients according to claim 1 characterized by the fact that it preferably contains a total of 7 proton pump inhibitor (PPI) drug units and 21 prokinetic and/or antiemetic drug units.
PCT/BR2004/000047 2003-04-09 2004-03-31 Drug packaging, or kit, or presentation facilitating self administration of drugs by patients WO2004089274A1 (en)

Applications Claiming Priority (2)

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BR8300543U BR8300543U (en) 2003-04-09 2003-04-09 Packaging, or drug kit, or patient-friendly presentation of drug administration
BRMU8300543-9 2003-04-09

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007093021A1 (en) * 2006-02-17 2007-08-23 Bayer Healthcare Ag Package, or drug kit, or drug smooth administration presentation for the treatment of hypertension, angina and others kinds of cardiovascular diseases.
WO2011113440A1 (en) 2010-03-18 2011-09-22 Futurelogix Aps A system for opening a medical blister package

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6132771A (en) * 1996-01-08 2000-10-17 Astrazeneca Ab Oral pharmaceutical dosage forms comprising a proton pump inhibitor and a prokinetic agent
US20020045184A1 (en) * 2000-10-02 2002-04-18 Chih-Ming Chen Packaging system

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6132771A (en) * 1996-01-08 2000-10-17 Astrazeneca Ab Oral pharmaceutical dosage forms comprising a proton pump inhibitor and a prokinetic agent
US20020045184A1 (en) * 2000-10-02 2002-04-18 Chih-Ming Chen Packaging system

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007093021A1 (en) * 2006-02-17 2007-08-23 Bayer Healthcare Ag Package, or drug kit, or drug smooth administration presentation for the treatment of hypertension, angina and others kinds of cardiovascular diseases.
WO2011113440A1 (en) 2010-03-18 2011-09-22 Futurelogix Aps A system for opening a medical blister package
US8459458B2 (en) 2010-03-18 2013-06-11 Medcomb Holding Aps Disposable rigid container for pharmaceutical compositions
US8991607B2 (en) 2010-03-18 2015-03-31 Medcomb Holding Aps System for opening a medical blister package
US9901512B2 (en) 2010-03-18 2018-02-27 Medcomb Holding Aps System for opening a medical blister package

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