Field of the Invention
The present invention relates to a dual purpose dosing device for measuring water for reconstitution of a product and the dose of the reconstituted product.
Background of the invention
Oral dosage forms for medicinal products vary from solid formulations, semisolid dosage forms to liquid formulations. The same are available as tablets, capsules, dispersible tablets, ointments, gels, lotions, creams, emulsions, suspensions, solutions, and so on. However one of the most important oral dosage forms is the suspension, both ready to use and also dry powders to be reconstituted before use. For several categories of patients like pediatric or geriatric patients, solid unit dosage forms present many difficulties in administration that range from difficulty in swallowing, unpleasant taste, and larger size of the dosage form. Apart from these, the solid dosage forms are difficult to administer in case of patients who have encountered severe trauma due to surgery or accidents.
Suspensions may be available as dry powders that have to be reconstituted before use. These dry powder suspensions are particularly useful in case of drugs that are moisture sensitive and undergo degradative reactions in presence of aqueous medium. The usual containers for such powders are glass or plastic bottles. In case of unit dose suspensions the same can be in the form of a sachet or a single use bottle pack. The bottles available in the market have markings for reconstitution of the product. Here the chances for accidental over dilution are more thereby causing erratic dosing. Considerable research has been made on the development of devices/containers for liquid formulations. In the past several years, a wide variety of plastic/glass devices for the dispensing of liquid dosage forms have been suggested and are in use.
WO05/019034 discloses a measuring cup adapted to serve as a closure for a package for liquids including a container, a transition collar and a measuring cup adapted to serve as a closure.
U.S. Patent 5,165,558 describes the dispensing containers having detachable accessories. More specifically this patent discloses a container having a break-away convenience cup for use in measuring and dispensing the contents of the container.
U.S. Patent 4, 550, 862 discloses a liquid pouring and measuring package having a measuring cup, which also serves as the closure for the package.
U.S. Patent 4, 917, 269 discloses liquid containing and dispensing package comprising a hollow plastic container having a neck comprising an upwardly extending integral dispensing spout, an integral web extending radially outwardly from the lower end of the dispensing spout and a cylindrical wall spaced radially outwardly of the spout and encircling the spout.
WO01/083093 discloses a device that comprises a mixing and dosing cup having an abrasive interior surface and includes a mixing blade attached to an external motor. In such type of device, a liquid dosage formulation can be prepared by combining a solid dosage form of a pharmaceutical medicament and an aqueous diluent in the mixing and dosing cup, agitating the resultant mixture, and administering the resulting liquid dosage formulation to a patient in the mixing and dosing cup.
The prior arts listed above provide packages or devices that can serve the purpose as a measuring cup as well as a closure. However, none of the prior arts address a device that serves the dual purpose of measuring the water for reconstitution and also the dose of the reconstituted product, especially for the dry powder pharmaceutical products to be reconstituted before use. Further, a number of measure cups are available in the market, which can fit on various caps and closures including Child Resistant Closures. But most of them perform only one function as either measuring devices for the water for reconstitution or the prepared suspension. Measurement of water for reconstitution of the product and the dose of the reconstituted product is important to avoid dilution errors and provide accurate doses of therapeutically active drugs such as antibiotics. Thus, it would be desirable to provide an improved and novel dosing cup device that allows the patient to measure the amount of water required for the reconstitution of the product and also helps in measuring the accurate dose of the product for administration. This dual purpose dosing
device helps in enhancing the patient compliance and acceptance and thus are better alternatives for the existing devices.
Summary of the invention
According to one embodiment there is provided, a dual purpose dosing device comprising: a first portion A having markings embossed on the dosing device for measuring the amount of water required for the reconstitution of a product; a second portion B having markings on the dosing device for measuring the accurate dose of the product for administration.
According to another embodiment there is provided, a dual purpose dosing device comprising: a first portion A having markings embossed on the dosing device for measuring the amount of water required for the reconstitution of a product; a second portion B having markings on the dosing device for measuring the accurate dose of the product for administration; and six equidistant vertical ridges along the inside wall of the first portion A.
According to another embodiment there is provided a kit comprising: A) a dual purpose dosing device comprising: a first portion A having markings embossed on the dosing device for measuring the amount of water required for reconstitution of a product; a second portion B having markings on the dosing device for measuring the accurate dose of the reconstituted product for administration; and optionally ridges along the inside wall of the first portion A, B) a bottle pack containing the product, wherein the dual purpose dosing device is fitted over the bottle pack.
According to still another embodiment there is provided, the dual purpose dosing device wherein the first portion A has markings ranging up to 150 ml and the second portion B has markings ranging up to 15 ml.
Brief description of the drawings Fig. 1 shows the top view of the dual purpose dosing device.
Fig. 2 shows the vertical view of the dual purpose dosing device. The base portion, shown as semicircle represents portion B and the upper portion, rectangular shaped portion mounted on semicircle, represents portion A. The inside wall of the portion A has number of ridges.
Fig. 3 shows the vertical view of the dual purpose dosing device with the markings for measurements. The markings 28, 33, 40 and 66 ml embossed on portion A aid in the measurement of exact amount of water required for the reconstitution of product. The markings 2.5, 5 and 10 ml embossed on portion B help in measuring the accurate dose of the product to be administered.
Detailed Description of the Invention
The dual purpose dosing device is designed to provide exact measurement of water required for the reconstitution of oral powder and also for accurate measurement of the dose for administration. Its visible markings make it easy to reconstitute the product with minimum or no errors and also aid in delivering the most precise dosage required for oral suspensions.
According to one embodiment the dual purpose dosing device comprises: a first portion A having markings embossed on the dosing device for measuring the amount of water required for the reconstitution of a product; a second portion B having markings on the dosing device for measuring the accurate dose of the product for the administration. The markings may be present on inner side or outer side of portion A and B depending on ease of measurement of water and the dose of the product respectively.
The first portion A has markings that range up to 150 ml, preferably up to 100 ml, more preferably up to 70 ml depending upon the strength of the product, dose of the
therapeutically active agent and total number of doses present in the multidose product. The markings for the water for reconstitution and also the prepared suspension are clearly visible. In situations where there are no available dispensing chemists or pharmacists and, where the suspension requires a volume like 28 ml, 33 ml or 66 ml of water for reconstitution of the product then it becomes a difficult task to exactly measure this quantity of water. This results in erroneous measurements leading to dilution errors. Variations in the dilutions can lead to unacceptable changes in the drug doses and strength that ultimately result in improper treatment of the disease. Such type of dilution errors is particularly more dangerous in case of antibiotics and other drugs having narrow therapeutic index. In such cases, the dual purpose dosing device can be considered as better alternative.
The second portion B has markings up to 15 ml, particularly for 2.5 ml, 5 ml and 10 ml for the purpose of administration of the dose of the product. Visual markings on the dome shaped cavity measure the exact dose to be delivered to the patient as per prescribed dosage regimen.
The device also has ridges along the inside wall of the first portion A. Preferably the ridges are vertical and equidistant, more preferably are six vertical equidistant ridges to fit exactly on a child resistant (CR) cap and shoulder of the bottle. The equidistant ridges are designed in such a way that they provide a good fit over the CR cap and the shoulder of the bottle.
According to another embodiment there is provided a kit comprising: A) a dual purpose dosing device comprising: a first portion A having markings embossed on the dosing device for measuring the amount of water required for reconstitution of a product; a second portion B having markings on the dosing device for measuring the accurate dose of the reconstituted product for administration; and optionally ridges along the inside wall of the first portion A, B) a bottle pack containing the product wherein the dual purpose dosing device is fitted over the bottle pack. The product may be an oral dry powder composition to be reconstituted before use comprising a therapeutically active agent. The therapeutically active agent may be any drug, preferably an antibiotic. More preferably, the product is
clarithromycin oral dry powder suspension or cefpodoxime proxetil oral dry powder suspension to be reconstituted before use.
The dual purpose dosing device is one-piece injection moulded and non sterile device. The device is made of polystyrene, high density polyethylene or polypropylene. Preferably the device is made of virgin grade polypropylene. However, any type of material, which serves the purpose of present invention, can be used.
The following non-limiting examples further illustrate the utility of dual purpose dosing device for measuring water for reconstitution of a product and the dose of the reconstituted product.
Example 1
The dual purpose dosing device having 28 and 40 ml volume markings on first portion A was provided with clarithromycin oral suspension for its 50 and 70 ml bottle pack respectively. The clarithromycin bottle pack that contains 35 g of dry powder to be reconstituted before use was made up to 50 ml by adding 28 ml of water with the help of 28 ml volume mark on dosing device to get 125 mg/5ml concentration of clarithromycin in the reconstituted suspension. Similarly, clarithromycin bottle pack that contains 49 g of dry powder to be reconstituted before use was made up to 70 ml by adding 40 ml of water with the help of 40 ml volume mark on dosing device to get 250 mg/5ml concentration of clarithromycin in the reconstituted suspension. Second portion B was provided with markings for 2.5, 5 and 10 ml volume markings for dispensing the dose of the product as prescribed by the physician.
Example 2
The dual purpose dosing device having 33 and 66 ml volume markings on first portion A was provided with cefpodoxime proxetil oral suspension for its 50 and 100 ml bottle pack respectively to get 40 mg/5ml concentration of cefpodoxime proxetil in the reconstituted suspension. Second portion B was provided with markings for 2.5, 5 and 10 ml volume markings for dispensing the dose of the product as prescribed by the physician.

WE CLAIM:
Claim 1: A dual purpose dosing device comprising:
A) a first portion A having markings embossed on the dosing device for measuring the
amount of water required for reconstitution of a product;
B) a second portion B having markings on the dosing device for measuring the
accurate dose of the reconstituted product for administration; and
C) optionally ridges along the inside wall of the first portion A.
Claim 2: The device as claimed in claim 1 wherein the inside wall of the first portion A contains six equidistant vertical ridges.
Claim 3: The device as claimed in claim 1 wherein the first portion A has markings ranging up to 150 ml and the second portion B has markings ranging up to 15 ml.
Claim 4: The device as claimed in any of the claims 1 to 3 wherein the first portion A has markings for 28, 33, 40 and 66 ml.
Claim 5: The device as claimed in any of the claims 1 to 3 wherein the second portion B has markings for 2.5, 5 and 10 ml.
Claim 6: A kit comprising:
A) a dual purpose dosing device comprising:
a) a first portion A having markings embossed on the dosing device for measuring the
amount of water required for reconstitution of a product;
b) a second portion B having markings on the dosing device for measuring the
accurate dose of the reconstituted product for administration; and
c) optionally ridges along the inside wall of the first portion A.
B) a bottle pack containing the product, wherein the dual purpose dosing device is fitted
over the bottle pack.
Claim 7: The kit as claimed in claim 6 wherein the product is clarithromycin oral dry powder suspension to be reconstituted before use.
Claim 8: The kit as claimed in claim 7 wherein the first portion A has markings for 28 and 40ml.
Claim 9: The kit as claimed in claim 6 wherein the product is cefpodoxime proxetil oral dry powder suspension to be reconstituted before use.
Claim 10: The kit as claimed in claim 9 wherein the first portion A has markings for 33 and 66ml.
Claim 11: The device as claimed in any of the preceding claims wherein said device is made of polypropylene, polystyrene or high density polyethylene.
Claim 12: A dual purpose dosing device substantially described and exemplified herein.