WO2019220190A1

WO2019220190A1 - Smart pen-type drug injection device for use in contraceptive therapy

Info

Publication number: WO2019220190A1
Application number: PCT/IB2018/055005
Authority: WO
Inventors: Kalak Abdul HAFEEZ
Original assignee: Hafeez Kalak Abdul
Priority date: 2018-05-18
Filing date: 2018-07-06
Publication date: 2019-11-21

Abstract

The present disclosure relates to a pen-type contraceptive drug injection device for use in female contraception. The pen-type contraceptive drug injection device incorporates smart features to monitor and record clinically relevant information such as drug information, dosage of drug, number of doses injected, number of doses remaining and timing and frequency of doses administered to patient. The recorded clinical information can help in allowing doctors and patients to gain a better understanding of how the medication is functioning to develop a customized treatment program. The disclosed pen-type contraceptive drug injection device further incorporates means to communicate data, in real time or on as required basis, to various stakeholders such as doctors, pharmaceutical companies, caregiver etc.

Description

SMART PEN-TYPE DRUG INJECTION DEVICE FOR USE IN CONTRACEPTIVE

THERAPY

FIELD OF THE INVENTION

[0001] The present disclosure relates to technical field of drug delivery device. In particular, the present disclosure relates to a smart pen-type drug injection device for use in female contraception.

BACKGROUND OF THE INVENTION

[0002] The background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0003] Medroxyprogesterone acetate, also known as 6-alpha-Methyl-l7-alpha- hydroxyprogesterone acetate, is a steroidal progestin used therapeutically as a contraceptive, in hormone replacement therapy and for the treatment of endometriosis. Medroxyprogesterone acetate and its preparation method are described in US Patent No. 3377364.

[0004] Journal of Reproduction and Fertility 1968, 15(2), 209-14 discloses a formulation comprising medroxyprogesterone acetate (25 mg) and estradiol cypionate (5 mg) which was used in a clinical study by monthly intramuscular (IM) injection for female contraception. Following each intramuscular (IM) injection there was a contraceptive effect for a one month time period following which the female had a menstrual period. Contraception 1997, volume 56, 353- 359 also discloses a clinical study of medroxyprogesterone acetate (25 mg) and estradiol cypionate (5 mg) by monthly intramuscular (IM) administration for female contraception.

[0005] United States Patent No. 4826831 discloses a method of hormonal treatment for menopausal disorders in a female subject, which comprises oral or intramuscular (IM) administration to the female subject of a combination of medroxyprogesterone acetate and an estrogen.

[0006] Although the above mentioned contraceptive formulations and administration methods thereof are capable of achieving contraceptive effect in human female, there are a number of disadvantages to using them. The major problem with intramuscular (IM) injection product is that it requires syringe with needle and a well trained medical professional to accomplish administration of the drug product. Further, intramuscular injection is often quite painful, which leads to patient discomfort and poor regimen compliance. Oral administration of medroxyprogesterone acetate is not satisfactory because the active ingredient is destroyed in the digestive tract with digestive juices and enzymes. Furthermore, oral dosage forms, such as tablets and capsules, require various pharmaceutical excipients to be admixed with the active ingredient. This unnecessarily increases the cost of final product.

[0007] Further, the currently marketed medroxyprogesterone acetate injection products (e.g., Cyclofem®) necessitate monthly intramuscular injection to achieve contraception in human female. As known to those skilled in the art, frequent intramuscular injection of medroxyprogesterone acetate causes considerable pain and discomfort to patient, thereby resulting in patient non-compliance with recommended usage instructions.

[0008] In addition, the commercially available injectable contraceptive preparations, for example Cyclofem®, combine medroxyprogesterone acetate with an estrogen. The estrogen contained in such combination, however, is considered to cause certain metabolic disturbances and hepatic or thrombo-embolic accidents. Consequently, this type of contraception is not feasible in all situations due to the risks of estrogen therapy or its contra-indication in certain patients.

[0009] Pen type injectors allowing an adjustable and accurate administration of contraceptive drug, such as progestins, are known in the art. However, the existing pen injector devices fail entirely to provide provisions for monitoring critical clinical information such as dose size, timing and frequency of doses administered to a patient, and for analyzing the monitored data in a way that would be useful for either contraceptive therapy or in a clinical setting. Another disadvantage of existing injector devices is that they provide no provision for communication with external networks or other functional units for recording critical clinical data and communicating the same to doctors, pharmaceutical companies, drug stores or caregiver in real time to enhance patient clinical care.

[00010] Accordingly, it would be advantageous to provide a pen-type contraceptive drug injection device with features to monitor and record clinically relevant data, thereby enhancing patient clinical care. Another advantage would be to provide a pen-type contraceptive drug injection device that is communicable in a web enabled environment to implement an effective medication management system. Yet another advantage would be to provide an injectable contraceptive formulation that comprises only medroxyprogesterone acetate as active ingredient for providing progestin-only contraception in female subjects to prevent pregnancy.

[00011] The present disclosure satisfies the existing needs, as well as others, and generally overcomes the deficiencies found in the prior art.

[00012] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.

[00013] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability.

OBJECTS OF THE INVENTION

[00014] It is an object of the present disclosure to provide a pen-type contraceptive drug injection device and injectable medroxyprogesterone acetate contraceptive formulation, which overcome at least some of the above-mentioned disadvantages of the prior art.

[00015] It is another object of the present disclosure to provide a pen-type contraceptive drug injection device that can monitor and store clinically relevant information and allow retrieval of stored data.

[00016] It is another object of the present disclosure to provide a pen-type contraceptive drug injection device that communicates with one or more paired devices and is operable in a web enabled environment.

[00017] It is another object of the present disclosure to provide a pen-type contraceptive drug injection device that can provide clinically relevant information in the form of video and audio.

[00018] It is another object of the present disclosure to provide a pen-type contraceptive drug injection device that can furnish clinically relevant information in a user’s preferred language. [00019] It is another object of the present disclosure to provide a pen-type contraceptive drug injection device with a unique identifier for tracking the device.

[00020] It is another object of the present disclosure to provide a pen-type contraceptive drug injection device that can indicate quality and quantity of contraceptive formulation used therein.

[00021] It is another object of the present disclosure to provide a pen-type contraceptive drug injection device that provides higher compliance rates and more lifestyle convenience for patients.

[00022] It is another object of the present disclosure to provide a pen-type contraceptive drug injection device that can be easily used by patients self-administering medication.

[00023] It is yet another object of the present disclosure to provide a method for providing progestin-only contraception in human female to prevent pregnancy.

SUMMARY

[00024] In order to accomplish the above objects, according to one aspect of the present disclosure, there is provided a smart pen-type drug injection device for use in female contraception. The pen- type drug injection device can include a cartridge comprising an injectable contraceptive solution of medroxyprogesterone acetate, a cartridge housing configured to hold the cartridge, and an injecting means configured to parenterally deliver a dose of the injectable contraceptive solution to a human female.

[00025] In an embodiment, the pen-type contraceptive drug injection device disclosed herein can incorporate smart features to monitor and record clinically relevant information such as drug information, dosage of drug, number of doses injected, number of doses remaining, timing and frequency of doses administered to patient, and quality and quantity of injectable formulation used in the cartridge. The recorded clinical information can help in allowing doctors and patients to gain a better understanding of how the medication is functioning to develop a customized treatment program. The disclosed pen-type contraceptive drug injection device can further include an indicating module for providing clinically relevant information to a user, such as a display screen for providing information in a visual format and an audio media for providing information in an auditory format.

[00026] In another embodiment, the disclosed pen-type contraceptive drug injection device can further incorporate means to communicate data in real time or on as required basis to various stakeholders such as doctor, care giver, pharmaceutical companies etc. In an embodiment, the means for communication can be a wireless communication means that can enable data transfer from the injection device to external functional units such as laptop, smart phone, tablet, etc, or networks. Wireless communication between the disclosed pen-type contraceptive drug injection device and external functional units or networks may be accomplished through any suitable communication channels such as Bluetooth, Wi-Fi, GSM communication means such as 3G etc. In another embodiment, the disclosed injection device can be configured to include a communication port that can facilitate connection of the injection device to external networks or other functional units through a communication cable.

[00027] In one embodiment, the cartridge used in the pen-type drug injection device can have a capacity of 3 ml.

[00028] In one embodiment, the injecting means used in the pen-type drug injection device can be a hollow needle, an array of hollow micro-needles or a needle free injection system.

[00029] In one illustrative embodiment, the cartridge comprises 2.6 ml of the injectable solution.

[00030] In an embodiment, the cartridge comprises four doses of the injectable solution, wherein each dose comprises 0.65 ml of the injectable solution. In various embodiments, each single dose of the injectable solution can be administered via subcutaneous route in a once- every-three month dosing regimen for the purpose of achieving a contraceptive effect in a female of reproductive age.

[00031] According to another aspect of the present disclosure there is provided a method for providing progestin-only contraception in a human female, the method comprises subcutaneously administering an injectable solution of medroxyprogesterone acetate to the human female using the pen injection device of the present disclosure.

[00032] In an embodiment, the injectable solution comprises medroxyprogesterone acetate at a concentration of 104 mg per 0.65 ml of the injectable solution, i.e. l60mg/ml solution.

[00033] In an embodiment of this aspect, the injectable solution can be administered to the human female subcutaneously at a dose of l04mg/0.65 ml once every 3 months for the purpose of providing contraception in the human female. [00034] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

BRIEF DESCRIPTION OF DRAWINGS

[00035] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. The diagrams are for illustration only, which thus is not a limitation of the present disclosure, and wherein:

[00036] FIG. 1 illustrates an exemplary block diagram indicating various functional parts/modules of a smart pen-type contraceptive drug injection device in accordance with embodiments of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

[00037] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure as defined by the appended claims.

[00038] If the specification states a component or feature“may”,“can”,“could”, or“might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[00039] As used in the description herein and throughout the claims that follow, the meaning of“a,”“an,” and“the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of“in” includes“in” and“on” unless the context clearly dictates otherwise.

[00040] Exemplary embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments are shown. These exemplary embodiments are provided only for illustrative purposes and so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those of ordinary skill in the art. The invention disclosed may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Various modifications will be readily apparent to persons skilled in the art. The general principles defined herein may be applied to other embodiments and applications without departing from the scope of the invention. Moreover, all statements herein reciting embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure). Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.

[00041] Each of the appended claims defines a separate invention, which for infringement purposes is recognized as including equivalents to the various elements or limitations specified in the claims. Depending on the context, all references below to the "invention" may in some cases refer to certain specific embodiments only. In other cases, it will be recognized that references to the "invention" will refer to subject matter recited in one or more, but not necessarily all, of the claims.

[00042] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g.,“such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[00043] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing. [00044] In one aspect, the present disclosure is directed to a pen-type contraceptive drug injection device for use in female contraception. The pen-type drug injection device can include a cartridge comprising an injectable contraceptive solution of medroxyprogesterone acetate, a cartridge housing configured to hold the cartridge, and an injecting means configured to parenterally deliver a dose of the injectable contraceptive solution to a human female. The pen- type contraceptive drug injection device disclosed herein can incorporate smart features to monitor and record clinically relevant information such as drug information, dosage of drug, number of doses injected, number of doses remaining, timing and frequency of doses administered to patient, recommended dosages, and quality and quantity of injectable formulation used in the cartridge. The recorded clinical information can help in allowing doctors and patients to gain a better understanding of how the medication is functioning to develop a customized treatment program. The disclosed pen-type contraceptive drug injection device can further include an indicating module for providing clinically relevant information to a user, such as a display screen for providing information in a visual format and an audio media for providing information in an auditory format.

[00045] The disclosed pen-type contraceptive drug injection device can further incorporate means to communicate data in real time or on as required basis to various stakeholders such as doctor, care giver, pharmaceutical companies etc. The means for communication can be a wireless or wired communication means that can enable data transfer from the injection device to external functional units such as laptop, smart phone, tablet, etc, or external networks.

[00046] FIG. 1 shows an exemplary block diagram 100 indicating various functional subsystems of the pen-type contraceptive drug injection device in accordance with embodiments of the present disclosure. As shown in FIG. 1, the pen-type injection device 100 can incorporate a drug delivery system 102 and an electronic system 110. The drug delivery system 102 can include a cartridge 104 for carrying a predetermined volume of an injectable contraceptive solution of medroxyprogesterone acetate, a cartridge hosing 106 for removably receiving and holding the cartridge 104 containing the injectable solution, and an injecting means 108 for parenterally delivering a dose of the injectable contraceptive solution to a human female.

[00047] In one embodiment, the cartridge 104 used in the drug delivery system can have a capacity of 3 ml. In an embodiment, the cartridge can contain 2.6 ml of the injectable solution. In an embodiment, the injectable solution comprises medroxyprogesterone acetate at a concentration of 104 mg per 0.65 ml of the injectable solution, i.e. l60mg/ml solution.

[00048] In one illustrative embodiment, the cartridge 104 comprises four doses of the injectable solution, wherein each dose comprises 0.65 ml of the injectable solution. Each single dose of the injectable solution can be administered subcutaneously in a once-every -three month dosing regimen for the purpose of achieving a contraceptive effect in a female of reproductive age, without loss of contraceptive effect during the intervening period.

[00049] In various embodiments, the cartridge 104 is prefilled with a predefined volume of the injectable contraceptive solution. In some embodiments, the cartridge is disposable.

[00050] In various embodiments, the injectable solution of medroxyprogesterone acetate can further include one or more pharmaceutically acceptable excipients. Examples of pharmaceutically acceptable excipients that can be used in the injectable solution of medroxyprogesterone acetate can include, but not limited to, aqueous solvent, non-aqueous vehicles, lubricants, preservatives, chelating agents, surfactants, antioxidants, buffers, pH adjusting agents, tonicity adjusting agents, and any other parenterally acceptable excipients known to the art, including any mixtures thereof.

[00051] In one illustrative embodiment, each 0.65 ml of the injectable solution of medroxyprogesterone acetate comprises:

[00052] In an embodiment, the cartridge hosing 106 can include a hollow body sized for removably receiving and holding the cartridge 104 in its loaded position.

[00053] In one embodiment, the injecting means 108 used in the drug delivery system 102 can be a hollow hypodermic needle suitable for subcutaneous or intramuscular injection.

[00054] In an alternative embodiment, the injecting means 108 can include an array of micro needles through which a dose of the injectable contraceptive solution can be subcutaneously injected. The micro-needles can be made of one or more rows of micro-needles of uniform or varying dimensions and geometries, with uniform or varying spacing. In some embodiments, the injecting means 108 can further include a sensor which can sense skin thickness of injection site and execute subcutaneous injection of the injectable contraceptive solution based on the thickness of skin.

[00055] In another alternative embodiment, the injecting means 108 can utilize needle-free injection technology for subcutaneously delivering a dose of the injectable contraceptive solution to a human female. Any needle-free injection technology known in the art for parenteral administration of a liquid medicament to human can be readily deployed in the practice of the present invention. In an exemplary embodiment, the injecting means 108 can be a needle- free injection system which works by a mechanism in which injectable solution is forced at a high pressure through a small opening that is held against an injection site. Due to this an ultrafine stream of high pressure medicine is created, that penetrates skin without the use of a needle.

[00056] According to embodiments of the present disclosure, the drug delivery system 102 can be made from materials that are non-corrosive, shatterproof and safe to be used for medical purposes. The materials can include, but not limited to, plastics, glass, polymers etc.

[00057] The pen-type contraceptive drug injection device 100 can further include an electronic system 110 which can include an interface module 112, a monitoring module 114, a data storage module 116, an indicating module 118, a communication module 120 and a processor module 122.

[00058] In an embodiment, the interface module 112 can be configured to permit user to interact with the pen-type drug injection device to observe critical clinical information, such as drug information, dosage of drug, number of doses injected, number of doses remaining, timing and frequency of doses administered to patient, recommended dosages, and quality and quantity of the injectable solution contained in the cartridge 104. The interface module 112 may also permit the user to control dose size, issue commands, to connect the pen-type drug injection device with external functional units, and the like. In one embodiment, the interface module 112 can be a touch panel or a key button array that can be disposed on the housing of the drug delivery system 102.

[00059] In an embodiment, the monitoring module 114 can be configured to monitor and record clinically relevant information such as, but not limited to, dose size, number of doses injected, number of doses remaining and timing and frequency of doses administered to patient. In some embodiments, the monitoring module 114 can also be configured to monitor quality and quantity of injectable contraceptive solution contained in the cartridge 104. The quantity information can include the amount of injectable solution in the cartridge, the volume capacity of the cartridge etc. The quality information can include drug identification, concentration, agglomeration, degradation etc.

[00060] In an embodiment, the data storage module 116 can be configured to store clinically relevant information such as, but not limited to, drug information, dosage of drug, number of doses injected, number of doses remaining, timing and frequency of doses administered to patient. In some embodiments, the clinically relevant information can be stored and retrieved on cloud computing networks. The stored information can provide records to help doctors and patients to gain a better understanding of how the medication is functioning to develop a customized treatment program.

[00061] In an embodiment, the indicating module 118 can be configured to provide one or more clinically relevant information to a user. In one embodiment, the indicating module 118 can be a display screen which can provide clinically relevant information such as drug information, dosage of drug, number of doses injected, number of doses remaining, timing and frequency of doses administered to patient, recommended dosages, medical warnings, contraindications and quality and quantity of injectable contraceptive solution contained in the cartridge and readiness information, in a visual format. The display screen can include any visual media such as light- emitting diodes (LEDs), liquid-crystal display (LCD) screens, optical polymers, fiber optic components etc.

[00062] In another embodiment, the indicating module 118 can be configured to provide the clinically relevant information and readiness information aurally through audio media such as a micro-speaker, a piezo-electric transducer or the like. Such sound output can include, an alarm, a series of beeps, recorded speech etc.

[00063] In one exemplary embodiment, the indicating module 118 can comprise a display screen for providing the clinically relevant information in a visual format and also a speaker for providing the clinically relevant information in an auditory format.

[00064] In another embodiment, the indicating module 118 can also be configured to display one or more of time, battery status, wireless or wired communication status and sound output level. The indicating module 118 can further be configured to communicate the clinically relevant information to users in their preferred language.

[00065] In one embodiment, the pen-type contraceptive drug injection device 110 can further include one or more visual and auditory indicators for signaling a user when the injection device is ready for an injection operation and when the device has completed a dose administration.

[00066] In an embodiment, the communication module 120 can be configured to communicate data in real time or on as required basis to various stakeholders such as doctor, caregiver, pharmaceutical companies etc. In an embodiment, the means for communication can be a wireless communication means that can enable data transfer from the pen-type drug injection device 100 to external functional units or networks such as, but not limited to computing devices, smart phones, tablets, networks, databases, other types of application software, etc. Wireless communication between the injection device 100 and external functional units or networks may be accomplished through any suitable communication channels such as, but not limited to, Bluetooth, Wi-Fi, GSM communication means such as 3G etc. Alternatively, the communication module 120 can be configured to include a communication port that can facilitate connection of the injection device 100 to external networks or other functional units through a communication cable. Thus, the pen-type drug injection device 100 and an external functional unit may communicate and provide information and/or instructions one to the other.

[00067] In an embodiment, the processer module 122 can be functionally coupled to the drug delivery system 102, the interface module 112, the monitoring module 114, the data storage module 116, the indicating module 118 and the communication module 120. The processor module 122 can receive commands from other modules, analyze the received commands, and execute data processing according to the analyzed commands. In an exemplary embodiment, the processer module 122 can be a digital signal processor configured to receive and process digital data provided by user.

[00068] Another aspect of the present disclosure is directed to a method for providing progestin-only contraception in a human female, the method comprises subcutaneously or intramuscularly administering an injectable solution of medroxyprogesterone acetate to the human female using the pen-type drug injection device of the present disclosure.

[00069] In an embodiment, the injectable solution comprises medroxyprogesterone acetate at a concentration of 104 mg per 0.65 ml of the injectable solution, i.e. l60mg/ml solution.

[00070] In an embodiment of this aspect, the injectable solution can be administered to the human female subcutaneously or intramuscularly at a dose of l04mg/0.65 ml once every 3 months for the purpose of providing contraception in the human female.

[00071] Only certain features of the invention have been specifically illustrated and described herein, and many modifications and changes will occur to those skilled in the art. The invention is not restricted by the preferred embodiment described herein in the description. It is to be noted that the invention is explained by way of exemplary embodiment and is neither exhaustive nor limiting. Certain aspects of the invention that not been elaborated herein in the description are well understood by one skilled in the art. Also, the terms relating to singular form used herein in the description also include its plurality and vice versa, wherever applicable. Any relevant modification or variation, which is not described specifically in the specification are in fact to be construed of being well within the scope of the invention. The appended claims are intended to cover all such modifications and changes which fall within the spirit of the invention.

[00072] The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation.

[00073] It should be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms“comprises” and“comprising” should be interpreted as referring to elements, components, or steps in a non exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification claims refer to at least one of something selected from the group consisting of A, B, C ....and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc. The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the appended claims.

[00074] While embodiments of the present disclosure have been illustrated and described, it will be clear that the disclosure is not limited to these embodiments only. Numerous modifications, changes, variations, substitutions, and equivalents will be apparent to those skilled in the art, without departing from the scope of the disclosure, as described in the claims.

[00075] In the description of the present specification, reference to the term “one embodiment,”“an embodiments”,“an example”,“an instance”, or“some examples” and the description is meant in connection with the embodiment or example described, the particular feature, structure, material, or characteristic included in the present invention, at least one embodiment or example. In the present specification, the term of the above schematic representation is not necessarily for the same embodiment or example. Furthermore, the particular features structures, materials, or characteristics described in any one or more embodiments or examples in proper manner. Moreover, those skilled in the art can be described in the specification of different embodiments or examples are joined and combinations thereof.

[00076] All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

[00077] Each feature disclosed in this specification (including any accompanying claims, abstract and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

[00078] The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[00079] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.

ADVANTAGES OF THE INVENTION

[00080] The present disclosure provides a pen-type contraceptive drug injection device that provides higher compliance rates and more lifestyle convenience for females who require contraception.

[00081] The present disclosure provides a pen-type contraceptive drug injection device that can monitor and store clinically relevant information and allow retrieval of stored data.

[00082] The present disclosure provides a pen-type contraceptive drug injection device that communicates with one or more paired devices, and is operable in a web enabled environment.

[00083] The present disclosure provides a pen-type contraceptive drug injection device that can provide clinically relevant information such as drug information, dosage of drug, number of doses injected, number of doses remaining, timing and frequency of doses administered to patient, recommended dosages, medical warnings and contraindications, in the form of video and audio. [00084] The present disclosure provides a pen-type contraceptive drug injection device that can furnish clinically relevant information in multiple languages.

[00085] The present disclosure provides a pen-type contraceptive drug injection device with a unique identifier for tracking the device.

[00086] The present disclosure provides a pen-type contraceptive drug injection device that can indicate quality of contraceptive formulation used therein.

[00087] The present disclosure provides a pen-type contraceptive drug injection device that can facilitate needleless injection of medroxyprogesterone acetate contraceptive formulation into a patient.

[00088] The present disclosure provides a pen-type contraceptive drug injection device for subcutaneous administration of an injectable contraceptive formulation comprising medroxyprogesterone acetate, which is safe, reliable and easy to use for self-administration by a human female in need of contraception.

[00089] The present disclosure provides a pen-type contraceptive drug injection device which can be easily used by patients self-administering medication.

[00090] The present disclosure provides a pen-type contraceptive drug injection device which comprises an injectable medroxyprogesterone acetate contraceptive formulation which provides long term contraceptive effect in human female.

Claims

I Claim:

1. A pen injection device, comprising:

a drug delivery system, comprising:

a cartridge comprising an injectable solution of medroxyprogesterone acetate;

a cartridge housing configured to hold said cartridge; and

an injecting means configured to parenterally deliver a dose of said injectable solution to a human female, and

an electronic system, comprising:

an interface module configured to provide an interaction between a user and the pen injection device;

a monitoring module configured to monitor and record clinically relevant information;

a data storage module configured to store said clinically relevant information;

an indicating module configured to provide said clinically relevant information in a visual format, an auditory format or a combination thereof;

a communication module configured to communicate said clinically relevant information to an external device; and

a processor module configured to process an input received from a user.

2. The pen injection device as claimed in claim 1, wherein said injecting means comprises a hollow needle.

3. The pen injection device as claimed in claim 1, wherein said injecting means comprises an array of hollow micro-needles.

4. The pen injection device as claimed in claim 1, wherein said injecting means comprises a needle free injection system.

5. The pen injection device as claimed in claim 1, wherein said clinically relevant information comprises drug information, dosage of drug, number of doses injected, number of doses remaining and timing and frequency of doses administered to human female.

6. The pen injection device as claimed in claim 1, wherein said communication module communicates said clinically relevant information wirelessly or in a wired mode.

7. The pen injection device as claimed in claim 1, wherein said indicating module provides said clinically relevant information in multiple languages.

8. The pen injection device as claimed in claim 1, wherein said pen injection device further comprises one or more identifiers for tracking the pen injection device.

9. The pen injection device as claimed in claim 1, wherein said cartridge has a capacity of 3 ml.

10. The pen injection device as claimed in claim 1, wherein said cartridge comprises 2.6 ml of said injectable solution.

11. The pen injection device as claimed in claim 1, wherein said injectable solution comprises medroxyprogesterone acetate at a concentration of 104 mg per 0.65 ml of said injectable solution.

12. The pen injection device as claimed in claim 1, wherein said cartridge comprises four doses of said injectable solution, wherein each dose comprises 0.65 ml of said injectable solution.

13. The pen injection device as claimed in claim 12, wherein each dose is administered via subcutaneous route in a once-every-three month dosing regimen.

14. The pen injection device as claimed in claim 1, wherein said injectable solution further comprises one or more pharmaceutically acceptable excipients.

15. A method for providing progestin-only contraception in a human female, comprising subcutaneously administering an injectable solution of medroxyprogesterone acetate to the human female using the pen injection device of claim 1.

16. The method as claimed in claim 15, wherein said injectable solution is administered at a dose of 0.65 ml containing 104 mg of medroxyprogesterone acetate.

17. The method as claimed in claim 16, wherein said dose is administered once every 3 months.