Medicament delivery kit

Abstract

Kits and methods may be for treatments with olanzapine or a pharmaceutically acceptable salt thereof. The kit may include a container; at least one tray disposed in the container; a pre-filled syringe containing a diluent comprising a biodegradable polymer excipient, the pre-filled syringe being disposed in a first compartment of the tray; a vial containing a medicament comprising olanzapine, the vial being disposed in a second compartment of the tray; a dosing syringe configured to administer the medicament, the dosing syringe being disposed in a third compartment of the tray; a dosing needle configured to be attached to the dosing syringe, the dosing needle being disposed in a fourth compartment of the tray; a first indicia on the tray corresponding to the first compartment; and a second indicia on the tray corresponding to the second compartment, wherein the second indicia is different than the first indicia. The kit may include a warming pack, and methods of use may include warming the diluent from a substantially solid state using the warming pack. The diluent may further comprise an organic solvent such as dimethyl sulfoxide. The diluent may be transferred to the vial to reconstitute the medicament, and the reconstituted medicament may be stored for up to 24 hours before use.

Description

MEDICAMENT DELIVERY KITTechnical Field

[0001] This disclosure relates generally to kits for use in preparing a medicament comprising olanzapine, or a pharmaceutically acceptable salt thereof and methods of using the kits. More particularly, this disclosure is directed to kits and methods for reconstituting a medicament comprising olanzapine, or a pharmaceutically acceptable salt thereof.Background

[0002] Medicaments are typically packaged with an informational sheet providing technical details of the medicine to the user, instructions for use of the medicine, and / or any relevant cautions and warnings. Medicaments may also be packaged as part of a kit along with any necessary components for preparation and / or delivery.Summary

[0003] The present inventors recognize that certain medicines and delivery devices have complicated instructions that may not be easy to follow. This is especially an issue with medication that needs to be packaged in a first state requiring the user to perform one or more steps to prepare the medication into a second state before administration. The preparation steps often require complicated handling of multiple components for reconstituting the medication in preparation for administration, which can give the user uncertainty and / or cause steps to be incorrectly followed.

[0004] For example, schizophrenia can be treated by a medication named olanzapine. Schizophrenia is a severely debilitating psychotic disorder characterized by positive symptoms (e.g., delusions, hallucinations, and grossly disorganized behavior) and negative symptoms (e.g., affective flattening, alogia, and avolition). Olanzapine has been approved for the treatment of schizophrenia and is available in intramuscular formulations. The present disclosure provides a kit that includes olanzapine in a powder state and additional components for reconstitution. The kit may include packaging with an intuitive layout of the components and clear information specific to the medication, providing confidence to the user during preparation and administration.

[0005] The present inventors further recognize that preparation and administration of a medication to patients with psychotic disorders can be especially challenging. The administration is often performed in a medical facility to ensure that the medication is properly prepared and administered, and the preparation steps can often be time-consuming. However, treating schizophrenic patients can often involve late or missed scheduled appointments. Thus, preparing the medication prior to arrival of the patient can lead to waste due to relatively short shelflife of some reconstituted medications. On the other hand, initiating preparation of the medicament uponarrival of the patient can lead to wait times that may not be suitable for patients with such psychiatric disorders.

[0006] The foregoing needs are met by the various embodiments as disclosed herein.

[0007] A first aspect of the present disclosure is directed to a kit including: a container; at least one tray disposed in the container; a pre-filled syringe containing a diluent (which may also be referred to as a vehicle) comprising a biodegradable polymer excipient, the pre-filled syringe being disposed in a first compartment of the at least one tray; a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof, the vial being disposed in a second compartment of the at least one tray; a dosing syringe configured to administer the medicament, the dosing syringe being disposed in a third compartment of the at least one tray; a dosing needle configured to be attached to the dosing syringe, the dosing needle being disposed in a fourth compartment of the at least one tray; a first indicia on or overlaying the at least one tray visually corresponding to the first compartment; and a second indicia on or overlaying the at least one tray visually corresponding to the second compartment, wherein the second indicia is different than the first indicia.

[0008] In some embodiments, the kit of the first aspect may include one or more of the following features. The kit may include a transfer needle configured to be attached to the pre-filled syringe, the transfer needle being disposed in a compartment of the at least one tray. The second indicia may group the second compartment and the compartment containing the transfer needle. The kit may include a vial adapter configured to be attached to the vial, the vial adapter being disposed in a compartment of the at least one tray. The vial adapter may be further configured to be directly attached to the pre-filled syringe for transferring the diluent from the pre-filled syringe to the vial without use of a transfer needle. The vial adapter may be further configured to be directly attached to the dosing syringe for transferring the medicament from the vial to the dosing syringe without use of a transfer needle. The second indicia may group the second compartment and the compartment containing the vial adapter. The kit may include a second transfer needle configured to be attached to the dosing syringe, the second transfer needle being disposed in a compartment of the at least one tray. A third indicia on or overlaying the at least one tray visually grouping the third compartment and the compartment and the compartment containing the second transfer needle. The transfer needle may be smaller than the second transfer needle. The transfer needle may be 21 gauge, and the second transfer needle may be 19 gauge. The transfer needle and the second transfer needle may both be 19 gauge. The transfer needle, the second transfer needle, and the dosing needle may each be 19 gauge. A third indicia may be on or overlaying the at least one tray visually corresponding to the third compartment, and a fourth indicia may be on or overlaying the at least one tray visually corresponding to the third compartment. The kit may include a first symbol on or overlaying the at least one tray, the first symbol corresponding to the first indicia, a second symbol on or overlaying the at least one tray, the second symbolcorresponding to the second indicia, a third symbol on or overlaying the at least one tray, the first symbol corresponding to the third indicia, a fourth symbol on or overlaying the at least one tray, the fourth symbol corresponding to the fourth indicia, wherein the first, second, third, and fourth symbols are visually progressive. The second indicia may be positioned on or overlaying the at least one tray between the first and third indicia, and the third indicia may be positioned on or overlaying the at least one tray between the second and fourth indicia. The kit may include a plurality of arrows on or overlaying the at least one tray, wherein each of the arrows extends between one of the symbols and the corresponding one of the compartments. The first compartment and the compartment that may contain the transfer needle are on a first portion of the at least one tray, the third compartment and the fourth compartment may be on a second portion of the at least one tray, and the first portion and the second portion may be on opposite sides of the at least one tray. The second compartment and the compartment that may contain the vial adapter are on a third portion of the at least one tray, and the third portion may be between the first portion and the second portion. The first compartment and the compartment containing the transfer needle may be arranged in a parallel orientation. A recess in the at least one tray may connect the first compartment and the second compartment. The third compartment and the fourth compartment may be arranged in a parallel orientation. A recess in the at least one tray may connect the third compartment and the fourth compartment. The kit may include a warming pack disposed over the at least one tray. The warming pack may be disposed over at least a portion of the first compartment. The kit may include a booklet disposed over the at least one tray, the booklet including drug information related to the olanzapine or a pharmaceutically acceptable salt thereof. The kit may include one or more ribs configured to laterally separate and secure the booklet and the warming pack. The kit may include a sheet disposed over the at least one tray, the sheet including a quick reference guide for using the kit. The warming pack may include at least one securement portion configured to secure the warming pack around the pre-filled syringe. The at least one securement portion may include a first portion having a plurality of hook structures and a second portion having a plurality of loop structures. The warming pack may include an insert configured to activate a solution inside of the warming pack to generate an exothermic reaction. The at least one tray may be separable from the container. The container may be a box including an enclosure and a lid, wherein the lid is configured to be opened to access the enclosure. The warming pack and the booklet may be positioned between the tray and the lid when the lid is in a closed configuration. The lid may have at least one panel defining a second enclosure, and the second enclosure is received in the first enclosure when the container is closed. The at least one tray may include a first tray and a second tray, the first tray is received in the enclosure, and the second tray is received in the second enclosure. At least one of the dosing syringe, the dosing needle, the transfer needle, the vial adapter, and the second transfer needle may be separately enclosed by an individual package. The dosing syringe may be in a first package, the dosing needle may be in asecond package, and each of the first package and the second package may have a flat back disposed in a vertical orientation with respect to the at least one tray. The transfer needle may be in a third package having a flat back disposed in a horizontal orientation with respect to the at least one tray. The vial adapter may be in a fourth package having a flat back disposed in a horizontal orientation with respect to the at least one tray. At least one of the individual packages, the first package, and the second package may be a blister pack. The vial may be individually packaged in a box. The first and second indicia may be directly printed onto the tray. For example, the first and second indicia may be directly printed onto the tray via inkjet printing. The kit may further include an insert disposed over the at least one tray and the first indicia and the second indicia may be formed or printed on the insert. The insert may include one or more openings aligned with the compartments. The insert may include a first opening aligned with the first compartment and the compartment including the transfer needle and a second opening aligned with the third compartment and the fourth compartment. The insert may include a third opening aligned with the second compartment and a fourth opening aligned with the compartment containing the vial adapter. The first indicia may include at least one first ring disposed at least partially around at least one of the first compartment and the second compartment, and the second indicia may include at least one second ring disposed at least partially around at least one of the third compartment and the fourth compartment. The at least one first ring may be a first color and / or pattern, and the at least one second ring may be a second color and / or pattern. The at least one first ring may include a ring around the first compartment and the compartment receiving the transfer needle and a ring around the second compartment, and wherein the at least one second ring may include a ring around the compartment receiving the vial adapter and a ring around the third and fourth compartments. The insert may include: a first partition attached at a first perforation and covering the pre-filled syringe and the vial, a second partition attached at a second perforation and covering the dosing syringe and the dosing needle, and the first partition and the second partition are individually openable. The insert may be in the form of a sleeve that receives the at least one tray. The container may have a central panel pivotably attached to the container, the central panel having a third indicia formed or disposed around a first portion, the third indicia corresponding to the first indicia, and a fourth indicia formed or disposed around a second portion, the fourth indicia corresponding to the second indicia. The kit may include a tab disposed over at least one of the compartments, wherein the tab is configured to deflect when a user removes a component from the respective compartment. The at least one tray may include a first tray portion and a second tray portion, the first compartment and the second compartment may be in the first tray portion, the third compartment and the fourth compartment may be in the second tray portion, and the first tray portion and the second tray portion are separable. The first tray portion may at least partially overlay the second tray portion. The dosing needle may be covered with a needle sheath and is attached to a safety shield. The diluent may include an organic solvent. The organic solvent maybe dimethylsulfoxide (DMSO). The diluent may have a melting point above 8°C. The kit and / or the medicament may be for treatment of a psychotic disorder. The kit and / or the medicament may be for the treatment of schizophrenia.

[0009] A second aspect of the present disclosure is directed to a method of preparing a dose of medicament for the treatment of a psychotic disorder, the method comprising: providing a kit, wherein the kit comprises: a container; at least one tray disposed in the container; a pre-fdled syringe containing a diluent comprising a biodegradable polymer excipient, the pre-fdled syringe being disposed in a first compartment of the at least one tray; a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof, the vial being disposed in a second compartment of the at least one tray; a dosing syringe configured to administer the medicament, the dosing syringe being disposed in a third compartment of the at least one tray; a dosing needle configured to be attached to the dosing syringe, the dosing needle being disposed in a fourth compartment of the at least one tray; a first indicia on or overlaying the at least one tray visually corresponding to the first compartment; and a second indicia on or overlaying the at least one tray visually corresponding to the second compartment, wherein the second indicia is different than the first indicia, wherein the method further comprises: transferring the diluent from the pre- filled syringe into the vial to reconstitute the medicament; and transferring a dose of the reconstituted medicament from the vial to the dosing syringe.

[0010] In some embodiments, the method of the second aspect may include one or more of the following features. The kit used in the method may be the kit of the first aspect described above.

[0011] A third aspect of the present disclosure is directed to a kit including: a pre-filled syringe containing a diluent comprising an organic solvent and a biodegradable polymer excipient; a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof; and a warming pack for warming the pre-filled syringe containing the diluent.

[0012] In some embodiments, the kit of the third aspect may include one or more of the following features. The kit may further comprise: a dosing syringe configured to administer the medicament; and a dosing needle configured to be attached to the dosing syringe. The kit may further comprise a container, wherein the pre-filled syringe, the vial, the dosing syringe, the dosing needle and the warming pack are disposed in the container. The kit may further comprises at least one tray disposed in the container, wherein: the pre-filled syringe is disposed in a first compartment of the at least one tray; the vial is disposed in a second compartment of the at least one tray; the dosing syringe is disposed in a third compartment of the at least one tray; and the dosing needle is disposed in a fourth compartment of the at least one tray. The warming pack may be disposed over the at least one tray. The kit and / or the medicament may be for the treatment of a psychotic disorder. The kit and / or the medicament may be for the treatment of schizophrenia.

[0013] The warming pack may include an insert configured to activate a solution inside the warming pack to generate an exothermic reaction. The warming pack may comprise an outerpouch containing the solution and the insert. The outer pouch may be formed at least one of polyvinyl chloride (PVC), polyethylene (PE) and nylon. The solution may be a solution of sodium acetate and water, and the insert may be a flexible metal disc. The solution may comprise from 70 wt% to 90 wt% of sodium acetate, with respect to the total weight of the solution. The flexible metal disc may be formed of stainless steel. The warming pack may include two or more chemical components that are physically separated by a barrier, wherein the barrier is configured to be rupturable to combine the two or more chemical components to bring about an exothermic reaction. The warming pack may include a solid composition configured to bring about an exothermic reaction in the presence of air or oxygen. The warming pack may be configured so that, after activation with the warming pack at a temperature of 20 °C, an outer surface of the warming pack reaches a maximum temperature of from 30 °C to 50 °C, when maintained in a room temperature environment having a temperature of 20 °C. The warming pack may be configured so that, after activation with the warming pack at a temperature of 5 °C, an outer surface of the warming pack reaches a maximum temperature of from 30 °C to 50 °C, when maintained in a room temperature environment having a temperature of 20 °C. The maximum temperature may be from 30 °C to 41 °C or from 40 °C to 50 °C. The warming pack may comprise a first warming pack part and a second warming pack part.

[0014] The kit may further include a transfer needle configured to be attached to the pre-filled syringe, the transfer needle being disposed in a compartment of the at least one tray. The kit may further include a vial adapter configured to be attached to the vial, the vial adapter being disposed in a compartment of the at least one tray. The kit may further include a second transfer needle configured to be attached to the dosing syringe, the second transfer needle being disposed in a compartment of the at least one tray. The first compartment and the compartment containing the transfer needle may be on a first portion of the at least one tray, the third compartment and the fourth compartment may be on a second portion of the at least one tray, and the first portion and the second portion are on opposite sides of the at least one tray. The second compartment and the compartment containing the vial adapter may be on a third portion of the at least one tray, and the third portion may be between the first portion and the second portion. The warming pack may include at least one securement portion configured to secure the warming pack around the pre-filled syringe. The at least one securement portion may include a first portion having a plurality of hook structures and a second portion having a plurality of loop structures. The warming pack may be a substantially planar flexible component and may be configured for wrapping around the pre-filled syringe.

[0015] The biodegradable polymer excipient of the diluent may be a pharmaceutically acceptable biodegradable polymer excipient. The biodegradable polymer excipient of the diluent may comprise poly(lactide), poly(glycolide), poly(lactide-co-glycolide), poly(lactic acid), poly(L- lactic acid), poly(D-lactic acid), ), poly(D,L-lactic acid), polyethylene glycol) and end cappedvariants or a copolymer of one or more of the foregoing, poly(aliphatic carboxylic acids), copolyoxalates, polycaprolactone, polydioxanone, poly(o / 7 / ?o carbonates), poly(acetals), poly(lactic acid-co-caprolactone), poly or thoesters, poly(glycolic acid-co-caprolactone), poly(amino acid), polyesteramide, polyanhydrides, polyphosphazines, poly(alkylene alkylate), biodegradable polyurethane, polyvinylpyrrolidone, polyalkanoic acid, albumin, chitosan, casein, or waxes, or blends and / or copolymers thereof. The biodegradable polymer excipient may be present in the diluent in an amount of from 15 wt% to 35 wt%, with respect to the total weight of the diluent.The organic solvent of the diluent may be dimethylsulfoxide (DMSO). The organic solvent may be present in the diluent in an amount of at least 65 wt% with respect to the total weight of the diluent. The organic solvent may be present in the diluent in an amount of from 65 wt% to 85 wt%, with respect to the total weight of the diluent. The diluent may consist essentially of the biodegradable polymer excipient and the organic solvent. The pre-fdled syringe may contain from 0.73 g to 2.5 g of the diluent. A barrel of the pre-fdled syringe may have an inner diameter of from 6 mm to 9 mm. A barrel of the pre-fdled syringe may be formed of glass. The diluent may have a melting point above 8°C. The diluent may have a melting point of from 12 °C to 18 °C. The diluent may be in a frozen, solid state when stored in a refrigerated environment having a temperature of from 2 °C to 8 °C. The diluent may be in a melted, liquid state in a room temperature environment having a temperature of from 20 °C to 25 °C. The pre-fdled syringe may comprise: a syringe body defining an elongate barrel and a distal tip having a sealed opening; a stopper slidably arranged in the barrel, wherein the syringe body and the stopper define a sealed chamber in which the diluent is contained; and a plunger rod slidably arranged in the barrel, a distal end of the plunger rod being arranged for displacing the stopper and a proximal end of the plunger rod being arranged for manual pressing to dispense the diluent through the opening. The syringe body may be formed of glass and the stopper may be formed of a resilient material, and the stopper may be radially compressed to form a seal with the barrel of the syringe body. The vial may contain from about 150 mg to about 1000 mg of olanzapine or a pharmaceutically acceptable salt thereof. The vial may contain from about 318 mg to about 950 mg of olanzapine or a pharmaceutically acceptable salt thereof.

[0016] A fourth aspect of the present disclosure is directed to a method including: receiving a pre-filled syringe containing a diluent comprising an organic solvent and a biodegradable polymer excipient, a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof, and a warming pack; storing the diluent in a substantially solid state; warming the diluent in the pre-filled syringe with the warming pack; and introducing the diluent into the vial to reconstitute the medicament.

[0017] In some embodiments, the method of the fourth aspect may include one or more of the following features. The method may further comprise transferring a dose of the reconstituted medicament from the vial to a dosing syringe. The method may further comprise administering thedose of the reconstituted medicament from the dosing syringe to a patient. The organic solvent of the diluent may be dimethylsulfoxide (DMSO). The organic solvent may be present in the diluent in an amount of at least 65 wt%, with respect to the total weight of the diluent. The organic solvent may be present in the diluent in an amount of from 65 wt% to 85 wt%, with respect to the total weight of the diluent. The biodegradable polymer excipient of the diluent may be a pharmaceutically acceptable biodegradable polymer excipient. The biodegradable polymer excipient may comprise poly(lactide), poly (glycolide), poly(lactide-co-glycolide), polylactic acid, poly-l(L-lactic acid, poly(D-lactic acid, ), poly(D,L-lactic acid), polyethylene glycol) and end capped variants or a copolymer of one or more of the foregoing, poly(aliphatic carboxylic acids), copolyoxalates, polycaprolactone, polydioxanone, poly(o / 7 / ?o carbonates), poly(acetals), poly(lactic acid-co-caprolactone), poly or thoesters, poly(glycolic acid-co-caprolactone), poly(amino acid), polyesteramide, polyanhydrides, polyphosphazines, poly(alkylene alkylate), biodegradable polyurethane, polyvinylpyrrolidone, polyalkanoic acid, albumin, chitosan, casein, or waxes, or blends and / or copolymers thereof. The biodegradable polymer excipient may be present in the diluent in an amount of from 15 wt% to 35 wt% with respect to the total weight of the diluent. The diluent may consist essentially of the biodegradable polymer excipient and the organic solvent. The pre-fdled syringe may contain from 0.73 g to 2.5 g of the diluent. A barrel of the pre-fdled syringe may have an inner diameter of from 6 mm to 9 mm. A barrel of the pre-fdled syringe may be formed of glass.

[0018] Storing the diluent in a substantially solid state may comprise storing the pre-fdled syringe and the warming pack in a container. The pre-fdled syringe and the warming pack may be removed from the container before warming the diluent in the pre-fdled syringe with the warming pack. Storing the diluent in a substantially solid state may include storing the diluent in a refrigerated environment maintained at or below 8°C, or from 2 °C to 8 °C. Warming the diluent in the-prefdled syringe may include transitioning the diluent from the substantially solid state into a liquid state. Warming the diluent may be to a temperature below body temperature prior to administration. Warming the diluent may be to at least 12°C.

[0019] The method may include manipulating an insert to generate an exothermic reaction in the warming pack. The warming pack may comprise an outer pouch containing the insert and a solution. The outer pouch may be formed at least one of polyvinyl chloride (PVC), polyethylene (PE) and nylon. The solution may be a solution of sodium acetate and water, and the insert may be a flexible metal disc. The flexible metal disc may be formed of stainless steel. The solution may comprise from 70 wt% to 90 wt% sodium acetate, with respect to the total weight of the solution. The warming pack may include two or more chemical components that are physically separated by a barrier, where is the barrier is ruptured to combine the two or more chemical components to bring about an exothermic reaction. The warming pack may include a solid composition which brings about an exothermic reaction in the presence of air or oxygen. Storing the diluent in a substantiallysolid state may comprise storing the diluent in the pre-filled syringe. Warming the diluent in the pre-filled syringe with the warming pack may comprise warming the pre-filled syringe with the warming pack. The method may include securing the warming pack around the pre-filled syringe with at least one securement portion by securing hook structures on a first securement portion onto loop structures on a second securement portion. The warming pack may be a substantially planar flexible component which is wrapped around the pre-filled syringe. An outer surface of the warming pack may reach a maximum temperature of from 30 °C to 50 °C, or from 30 °C to 41 °C, or from 40 °C to 50 °C.

[0020] Warming the diluent in the pre-filled syringe may comprise: removing the pre-filled syringe from the refrigerated environment; and arranging the warming pack at least partially around the pre-filled syringe for a warming period of time that is up to 30 minutes. The warming period of time may be up to 15 minutes. The warming period of time may be at least 5 minutes. The warming period of time may be 15 minutes. The method may further comprise, after the removing the pre-filled syringe from the refrigerated environment and before arranging the warming pack at least partially around the pre-filled syringe, conditioning the pre-filled syringe and the warming pack in a room temperature environment for a conditioning period of time that is up to 45 minutes. The conditioning period of time may be up to 30 minutes. The conditioning period of time may be at least 10 minutes. The conditioning period of time may be 30 minutes. The conditioning period of time may be 15 minutes. The room temperature environment may have a temperature of from about 20 °C to about 25 °C.

[0021] The method may include attaching a transfer needle to the pre-filled syringe; and puncturing a stopper of the vial with the transfer needle to introduce the diluent into the vial. The container may enclose a vial adapter, and the method further may include securing the vial adapter to the vial containing the reconstituted medicament, and attaching the dosing syringe to the vial adapter to transfer the reconstituted medicament to the dosing syringe. The container may enclose a vial adapter, and the method further may include securing the vial adapter to the vial; attaching the prefilled syringe to the vial adapter to introduce the diluent into the vial; attaching the dosing syringe to the vial adapter after reconstituting the medicament; and transferring a dose of the reconstituted medicament from the vial to a dosing syringe. The pre-filled syringe may comprise: a syringe body defining an elongate barrel and a distal tip having a sealed opening; a stopper slidably arranged in the barrel, wherein the syringe body and the stopper define a sealed chamber in which the diluent is contained; and a plunger rod slidably arranged in the barrel, a distal end of the plunger rod being arranged for engaging the stopper, wherein introducing the diluent into the vial to reconstitute the medicament further comprises pressing a proximal end of the plunger rod to displace the stopper and transfer the diluent into the vial. The syringe body may be formed of glass and the stopper may be formed of a resilient material, and the stopper may be radially compressed to form a seal with the barrel of the syringe body. The method may include equalizing pressure inthe vial after introducing the diluent by pulling back a plunger of the dosing syringe without drawing the diluent. The vial may contain from about 150 mg to about 1000 mg of olanzapine or a pharmaceutically acceptable salt thereof. The vial may contain from about 318 mg to about 950 mg of olanzapine or a pharmaceutically acceptable salt thereof. The medicament may be for the treatment of a psychotic disorder. The medicament may be for the treatment of schizophrenia.

[0022] A fifth aspect of the present disclosure is directed to use of a warming pack for transitioning a diluent for use in reconstituting a powdered medicament from a solid state to a liquid state, the diluent being contained in a pre-filed syringe and comprising an organic solvent and a biodegradable polymer excipient, wherein the warming pack is wrapped around the pre-filled syringe.

[0023] A sixth aspect of the present disclosure is directed to a method including: receiving a prefilled syringe containing a diluent comprising an organic solvent and a biodegradable polymer excipient, the organic solvent being dimethyl sulfoxide (DMSO); receiving a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof; introducing the diluent into the vial to reconstitute the medicament; and storing the reconstituted medicament for up to about 24 hours in a room temperature environment.

[0024] In some embodiments, the method of the sixth aspect may include one or more of the following features. The organic solvent may be present in the reconstituted medicament in an amount of from 30 wt% to 70 wt%, with respect to the total weight of the reconstituted medicament. The organic solvent may be present in the reconstituted medicament in an amount of from 35 wt% to 65 wt%, with respect to the total weight of the reconstituted medicament. The biodegradable polymer excipient may be present in the reconstituted medicament in an amount from 10 wt% to 25 wt%, with respect to the total weight of the reconstituted medicament. Olanzapine or a pharmaceutically acceptable salt thereof may be present in the reconstituted medicament in an amount from 20 wt% to 45 wt%, with respect to the total weight of the reconstituted medicament. The biodegradable polymer excipient of the diluent may be a pharmaceutically acceptable biodegradable polymer excipient. The biodegradable polymer excipient of the diluent may comprise poly(lactide), poly(glycolide), poly(lactide-co-glycolide), poly(lactic acid), poly(L-lactic acid), poly(D-lactic acid), poly(D,L-lactic acid), polyethylene glycol) or end capped variants or a copolymer of one or more of the foregoing, poly(aliphatic carboxylic acids), copolyoxalates, polycaprolactone, polydioxanone, poly(o / 7 / ?o carbonates), poly(acetals), poly(lactic acid-co-caprolactone), polyo / v / iocstcrs. poly(glycolic acid-co- caprolactone), poly(amino acid), polyesteramide, polyanhydrides, polyphosphazines, poly(alkylene alkylate), biodegradable polyurethane, polyvinylpyrrolidone, polyalkanoic acid, albumin, chitosan, casein, or waxes, or blends and / or copolymers thereof. The diluent may consist essentially of the organic solvent and the biodegradable polymer excipient and the organic solvent. The reconstituted medicament may consist essentially of the organic solvent, the biodegradable polymerexcipient and olanzapine or a pharmaceutically acceptable salt thereof. The pre-filled syringe many contain from 0.73 g to 2.5 g of the diluent. The vial may contain from 318 mg to 950 mg of olanzapine or a pharmaceutically acceptable salt thereof.

[0025] The method may include, before introducing the diluent into the vial to reconstitute the medicament, storing the diluent in a solid state in a refrigerated environment of at or below 8°C. The method may further comprise, before introducing the diluent into the vial to reconstitute the medicament, warming the diluent in the pre-fdled syringe. The diluent may be warmed by arranging a warming pack around the pre-fdled syringe. The warming of the diluent in the pre- fdled syringe may cause the diluent to transition from the solid state to a liquid state. Introducing the diluent into the vial to reconstitute the medicament may comprise introducing the diluent into the vial so that the diluent and medicament are present in the vial in a weight ratio of from 2.0 to 2.5.

[0026] The method may include storing the reconstituted medicament for up 18 hours in a room temperature environment. The method may include storing the reconstituted medicament for up to 12 hours in a room temperature environment. The method may include storing the reconstituted medicament for up to 6 hours in a room temperature environment. The method may include storing the reconstituted medicament for at least 1 hour in a room temperature environment. The method may include storing the reconstituted medicament for at least 6 hours in a room temperature environment. The method may include storing the reconstituted medicament for at least 12 hours in a room temperature environment. The method may include storing the reconstituted medicament for at least 18 hours in a room temperature environment. The room temperature environment may have a temperature of from about 20 °C to about 25 °C. The method may include storing the reconstituted medicament in a room temperature environment, with permitted excursions at 15 °C to 30 °C. Storing the reconstituted medicament may comprise storing the reconstituted medicament as a liquid suspension. Storing the reconstituted medicament may comprise storing the reconstituted medicament in the vial.

[0027] The method may further comprise, after storing the reconstituted medicament, transferring a dose of the reconstituted medicament from the vial to a dosing syringe. The method may further comprise, after transferring a dose of the reconstituted medicament from the vial to a dosing syringe, administering the dose of the reconstituted medicament from the dosing syringe to a patient. The method may include attaching a transfer needle to the prefilled syringe, wherein introducing the diluent into the vial comprises piercing a stopper of the vial with the transfer needle. The method may include attaching a second transfer needle to the dosing syringe, wherein transferring the dose of reconstituted medicament comprises piercing the stopper with the second transfer needle. The transfer needle and the second transfer needle may be 21 gauge. The method may include attaching a vial adapter containing a self-sealing valve to the vial, wherein introducing the diluent into the vial comprises attaching the prefilled syringe to the vial adapter, and whereintransferring a dose of the reconstituted medicament from the vial to the dosing syringe comprises attaching the dosing syringe to the vial adapter. The method may include after the storing step, shaking the vial to mix the diluent and the olanzapine or a pharmaceutically acceptable salt thereof. The method may include shaking the vial for about 30 seconds. The medicament may be for the treatment of a psychotic disorder. The medicament may be for the treatment of schizophrenia.

[0028] A seventh aspect of the present disclosure is directed to a kit for reconstituting a medicament, the kit comprising: a pre-filled syringe containing a diluent comprising an organic solvent and a biodegradable polymer excipient, the organic solvent being dimethyl sulfoxide (DMSO); a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof; and either: a transfer needle configured at one end for attaching to the pre-filled syringe and at the other end for piercing a stopper of the vial for introducing the diluent into the vial to reconstitute the medicament; or a vial adapter having a self-sealing valve and configured for attaching the dosing syringe for introducing the diluent into the vial to reconstitute the medicament.

[0029] In some embodiments, the kit of the seventh aspect may include one or more of the following features. The organic solvent may be present in the diluent in an amount of at least 70 wt%, with respect to the total weight of the diluent. The organic solvent may be present in the diluent in an amount of from 70 wt% to 90 wt%, with respect to the total weight of the diluent. The biodegradable polymer excipient of the diluent may be a pharmaceutically acceptable biodegradable polymer excipient. The biodegradable polymer excipient of the diluent may comprises poly(lactide), poly (glycolide), poly(lactide-co-glycolide), poly(lactic acid), poly(L-lactic acid, poly(D-lactic acid, poly(D,L-lactic acid), polyethylene glycol) or end capped variants or a copolymer of one or more of the foregoing, poly(aliphatic carboxylic acids), copolyoxalates, polycaprolactone, polydioxanone, poly(o / 7 / ?o carbonates), poly(acetals), poly(lactic acid-co- caprolactone), polyorthoesters, poly(glycolic acid-co-caprolactone), poly(amino acid), polyesteramide, polyanhydrides, polyphosphazines, poly(alkylene alkylate), biodegradable polyurethane, polyvinylpyrrolidone, polyalkanoic acid, albumin, chitosan, casein, or waxes, or blends and / or copolymers thereof. The biodegradable polymer excipient may be present in the diluent in an amount of from 10 wt% to 30 wt% with respect to the total weight of the diluent. The diluent may consist essentially of the organic solvent and the biodegradable polymer excipient and the organic solvent. The pre-filled syringe may contain from 0.73 g to 2.5 g of the diluent. The vial may contain from 318 mg to 950 mg of olanzapine or a pharmaceutically acceptable salt thereof. The kit may further comprise a warming pack for warming the diluent in the pre-filled syringe. The kit and / or the medicament may be for the treatment of a psychotic disorder. The kit and / or the medicament may be for the treatment of schizophrenia.

[0030] An eighth aspect of the present disclosure is directed to use of a diluent comprising an organic solvent and a biodegradable polymer excipient for extending the shelf life of a reconstituted medicament comprising olanzapine or a pharmaceutically acceptable salt thereof,wherein the organic solvent is dimethyl sulfoxide (DMSO), wherein the diluent is introduced into a vial containing the medicament comprising olanzapine or a pharmaceutically acceptable salt thereof to reconstitute the medicament, and wherein the dimethyl sulfoxide is present in the reconstituted medicament in an amount of from 30 wt% to 70 wt%, with respect to the total weight of the reconstituted medicament. In embodiments, the reconstituted medicament may be stored as a liquid suspension in the vial for at least 1 hour, and thereafter a dose of the reconstituted medicament may be transferred from the vial to a dosing syringe.Brief Description of the Drawings

[0031] The present application is further understood when read in conjunction with the appended drawings. For the purpose of illustrating the subject matter, there are shown in the drawings exemplary embodiments of the subject matter; however, the presently disclosed subject matter is not limited to the specific methods, kits, devices, and systems disclosed. In the drawings:

[0032] FIG. 1 illustrates a first embodiment of a kit according to the present disclosure.

[0033] FIG. 2 illustrates a warming pack and an instruction sheet or booklet packaged into a container of the kit of FIG. 1.

[0034] FIG. 3 illustrates a medicament delivery system packaged into a tray inside of the container of the kit of FIGS. 1 and 2.

[0035] FIG. 4 illustrates an exploded view of the kit of FIGS. 1-3.

[0036] FIG. 5 illustrates a first embodiment of the medicament delivery system of the kit of FIGS. 1-4.

[0037] FIG. 6 illustrates a second embodiment of the medicament delivery system of the kit of FIGS. 1-4.

[0038] FIG. 7 illustrates an exploded view of a vial adapter of the medicament delivery system of FIG. 6.

[0039] FIG. 8 illustrates a cross-section of the vial adapter of FIGS. 6 and 7 in a sealed state.

[0040] FIG. 9 illustrates a cross-section of the vial adapter of FIGS. 6-8 in an actuated state.

[0041] FIG. 10 illustrates the warming pack of the kit of FIGS. 1-9.

[0042] FIG. 11 illustrates a third embodiment of the medicament delivery system of the kit of FIGS. 1-4.

[0043] FIG. 12 illustrates a method of administering a medicament according to the present disclosure.

[0044] FIG. 13 illustrates a second embodiment of a kit according to the present disclosure.

[0045] FIG. 14 illustrates a process of accessing a first opening of the kit of FIG. 13.

[0046] FIG. 15 illustrates a partially exploded view of a first group of medicament delivery components of the kit of FIGS. 13 and 14.

[0047] FIG. 16 illustrates a process of accessing a second opening of the kit of FIGS. 13-15.

[0048] FIG. 17 illustrates a partially exploded view of a second group of medicament delivery components of the kit of FIGS. 13-16.

[0049] FIG. 18 illustrates an exploded view of the kit of FIGS. 13-17.

[0050] FIG. 19 illustrates a third embodiment of a kit according to the present disclosure.

[0051] FIG. 20 illustrates a medicament delivery system packaged inside of a tray inside of a container of the kit of FIG. 19.

[0052] FIG. 21 illustrates a warming pack and an instruction sheet or booklet packaged into the container of the kit of FIG. 19 and 20.

[0053] FIG. 22 illustrates a vial of the medicament delivery system being removed from the tray of the kit of FIGS . 19-21.

[0054] FIG. 23 illustrates an exploded view of the kit of FIGS. 19-22.

[0055] FIG. 24 illustrates a fourth embodiment of a kit according to the present disclosure.

[0056] FIG. 25 illustrates an instruction sheet being removed from the kit of FIG. 24.

[0057] FIG. 26 illustrates the instruction sheet of the kit of FIGS. 24 and 25.

[0058] FIG. 27 illustrates a label of the kit of FIGS. 24-26.

[0059] FIG. 28 illustrates a warming pack packaged into a container of the kit of FIGS. 24-27.

[0060] FIG. 29 illustrates a medicament delivery system packaged into the tray of the kit ofFIGS. 24-28.

[0061] FIG. 30 illustrates an exploded view of the kit of FIGS. 24-29.

[0062] FIG. 31 illustrates a fifth embodiment of a kit according to the present disclosure.

[0063] FIG. 32 illustrates a sixth embodiment of a kit according to the present disclosure.

[0064] FIG. 33 illustrates a tray assembly of the kit of FIG. 32.

[0065] FIG. 34 illustrates a partially exploded view of the kit of FIGS. 32 and 33.

[0066] FIG. 35 illustrates a first partition of the kit of FIGS. 32-34.

[0067] FIG. 36 illustrates, when partially unpacked, the kit of FIGS. 32-35.

[0068] FIG. 37 illustrates a partially exploded view of the kit of FIGS. 32-36.

[0069] FIG. 38 illustrates a second insert of the kit of FIGS. 32-37.

[0070] FIG. 39 illustrates, when partially unpacked, the kit of FIGS. 32-38.

[0071] FIG. 40 illustrates a seventh embodiment of a kit according to the present disclosure.

[0072] FIG. 41 illustrates, when partially unpacked, the kit of FIG. 40.

[0073] FIG. 42 illustrates a first group of components of a medicament delivery system in a first tray of the kit of FIG. 40.

[0074] FIG. 43 illustrates a second group of components of a medicament delivery system in a second tray of the kit of FIG. 41 and 42.

[0075] FIG. 44 illustrates a partially exploded view of the kit of FIGS. 41 and 43.

[0076] FIG. 45 illustrates an eight embodiment of a kit according to the present disclosure.

[0077] FIG. 46 illustrates a ninth embodiment of a kit according to the present disclosure.

[0078] FIG. 47 illustrates a tenth embodiment of a kit according to the present disclosure.

[0079] FIG. 48 illustrates a method of stacking trays of the kit according to FIG. 47.

[0080] FIG. 49 illustrates initiation forces for pre-fdled syringes measured after using different methods for warming the syringes.

[0081] Aspects of the disclosure will now be described in detail with reference to the drawings, wherein like reference numbers refer to like elements throughout, unless specified otherwise.Detailed Description of Illustrative Embodiments

[0082] The present disclosure is directed to various embodiments of a kit for reconstituting a medicament using a diluent (which may also be referred to as a vehicle). The kit may provide structural features and / or indicia that ensure that clear navigation is provided to the user throughout the process of preparing and administering the medicament. The kit may draw attention to key steps. The kit may aid in or simplify handling the components, doing more than just housing the components. For example, the kit may arrange and / or orient the components of the medicament delivery system laterally and / or vertically in an intuitive manner, clarifying an order of operation of the components. In some embodiments, the kit may include indicia and / or numbering (e.g., colorcoding) to provide a clear indication of the order of operation. For example, the indicia may include rings that visually indicate the order of operation of the components. The kit may, additionally or alternatively, at least partially hide or obscure components to provide a visual indication of the order of operation of the components. For example, components that are intended to be used early in an injection process may be more prominently displayed than components intended to be used later in the process. Additionally or alternatively, components may be at least partially layered, such that one component or another part of the kit may need to be removed to gain access to another component. The present disclosure is also directed to various embodiments of a method of using the kit.

[0083] The kit may be adapted for packaging medicament for the treatment of a psychotic disorder, such as schizophrenia. Thus, the kit of the present disclosure may include a warming pack that expedites transition of the components from refrigerated storage to shorten required medication preparation times to better accommodate uncertainty in patient attendance of scheduled appointments at medical facilities.

[0084] Furthermore, the present disclosure is directed to various embodiments of a kit that includes a warming pack that expedites transition of a diluent in a pre-filled syringe from refrigerated storage to shorten required medication preparation times to better accommodate uncertainty in patient attendance of scheduled appointments at medical facilities. The warming pack may expedite the transition of the diluent from a substantially solid state to a liquid state in which the diluent can be transferred from the pre-filled syringe. Use of the warming pack in this way may also result in reduced initiation forces when transferring the diluent from the pre-filledsyringe. The present disclosure is also directed to various embodiments of a method of using a warming pack to expedite transition of a diluent in a pre-fdled syringe from refrigerated storage to shorten required medication preparation times to better accommodate uncertainty in patient attendance of scheduled appointments at medical facilities.

[0085] Furthermore, the present disclosure is directed to various embodiments of a method that may provide for a medicament to be reconstituted using a diluent comprising an organic solvent in the form of dimethyl sulfoxide (DMSO). Upon reconstitution, the reconstituted medicament may have a shelf life at room temperature of up to 24 hours, thus accounting for unintended delays of administering the medicament. In some embodiments, the diluent may be stored in a solid state at refrigerated temperatures less than or equal to 8°C (e.g., 2°C to 8°C). Pharmaceutical compositions and methods of the present disclosure are provided in WO2023 / 139531A1 (entitled “Olanzapine, compositions thereof and methods of use thereof’) and US2024 / 0238308A1 (entitled “Olanzapine compositions and methods of use”), both applications are expressly incorporated herein by reference.

[0086] FIGS. 1-4 illustrate a first embodiment of a kit 100 for a medicament delivery system. The kit 100 may include a container 102, a tray 130, an insert 150, and a medicament delivery system. As illustrated, the medicament delivery system may include a pre-filled syringe 200, a transfer needle 220, a vial 230, a vial adapter 240 (or 240’), a dosing syringe 260, and a dosing needle 270. The kit 100 may further include at least one sheet or booklet 190 including information such as instructions for use (IFU) and / or a warming pack 280.

[0087] As illustrated, the container 102 may be a box formed by a plurality of panels and having an enclosure that receives the tray 130. The panels may include a plurality of vertical panels extending vertically from a bottom panel (not shown) to define the enclosure. The vertical panels may include a front panel 104, a pair of side panels 106, and a rear panel (not shown). The container 102 may further include a panel in the form of a lid 108 configured to cover the enclosure during storage and shipment. The lid 108 may be pivotably attached to the rear panel. A flap 110 may be pivotably attached to the lid 108 and be configured to attach to the front panel 104 to secure the container 102 in a closed configuration. The flap 110 may be releasably secured to the front panel, for example, with an adhesive and / or a heat seal that may be broken by the user to pivot the lid 108 into an open configuration. However, in alternative embodiments, the lid 108 may not be pivotably attached, but rather be opened in a vertical direction similar to a shoe box. The front panel 104 and the rear panel may have the same length, and the side panels 106 may have the same length to form a square or rectangular cross-section. In some embodiments, the length of the front panel 104 and the rear panel may be greater than the length of the side panels 106 to provide a favorable rectangular layout of the components, as illustrated in FIGS. 1-4. For example, the container 102 when closed may have a length of about 190 mm defined by the front panel 104 and the rear panel and a width of about 140 mm defined by the side panels 106. The container 102 mayhave a height ranging from about 32 to 40 mm defined by the vertical panels. The container 102 may be made of cardboard due to the light weight and recyclability.

[0088] The tray 130 may have a plurality of compartments to receive components of the medicament delivery system. The tray 130 may have a first compartment 132 receiving the prefilled syringe 200, a second compartment 134 receiving the transfer needle 220, and a third compartment 136 receiving the vial 230. The tray 130 may further have a fourth compartment 138 receiving the vial adapter 240, a fifth compartment 140 receiving the dosing syringe 260, and a sixth compartment 142 receiving the dosing needle 270. One or more of the pre-filled syringe 200, the transfer needle 220, the vial 230, the vial adapter 240, the dosing syringe 260, and / or the dosing needle 270 may be individually packaged inside of the tray 130, for example in a blister pack. The compartments may be sized and shaped according to a profile of the component and / or packaging. The compartments may be arranged to conserve space and reduce the size of the container 102. The compartments may include peripheral recesses to provide additional space to receive fingers around the components to facilitate grasping by the user. The first compartment 132 and the second compartment 134 may be approximated and extend substantially parallel. The first compartment 132 and the second compartment 134 may be in communication with each other or connected, for example, with a recess in a wall of the tray 130 between the first compartment 132 and the second compartment 134 to facilitate grasping of the components. The fifth compartment 140 and the sixth compartment 142 may be approximated and extend substantially parallel. The fifth compartment 140 and the sixth compartment 142 may be in communication with each other or connected, for example, with a recess in a wall of the tray 130 between the fifth compartment 140 and the sixth compartment 142 to facilitate grasping of the components. The insert 150 may overlay the tray 130 and have one or more openings that align with one or more of the compartments 132-142. For example, as illustrated in FIG. 4, the insert 150 may include a first opening 160 aligned with the first and second compartments 132, 134, a second opening 162 aligned with the third compartment 136, a third opening 164 aligned with the fourth compartment 138, and a fourth opening 166 aligned with the fifth and sixth compartments 140, 142. Each of the compartments 132-142 may have an upper opening to be readily accessible to the user, for example through one of the openings in the insert 150.

[0089] The tray 130 and / or the insert 150 may provide an intuitive layout of the medicament delivery system to provide a clear navigation through the preparation and administration of the medicament. The layout may also organize the components of the medicament delivery system into at least two separate groups. The first group may include components for preparing the medicament, such as reconstituting the powder or lyophilized medicament. The second group may include components for administering the reconstituted medicament. For example, the first group may include the pre-filled syringe 200, the transfer needle 220, and the vial 230, and the second group may include the vial adapter 240, the dosing syringe 260, and the dosing needle 270.However, additional groupings are contemplated as further discussed with reference to the eighth embodiment (Fig. 45) and the ninth embodiment (Fig. 46), as expressly incorporated herein. The layout may further indicate an order of operation for the components to minimize a possibility of the user performing steps out of order.

[0090] In some embodiments, the tray 130 may spatially indicate the order of operation based on the layout of the components of the medicament delivery system, for example from left to right. The first compartment 132 and the second compartment 134 may be on a first portion 144 of the tray 130, the third compartment 136 and the fourth compartment 138 may be on a second portion 146 of the tray 130, and the fifth compartment 140 and the sixth compartment 142 may be on a third portion 148 of the tray 130. The first portion 144 and the third portion 148 may be on opposite sides of the tray 130, for example on opposite sides with respect to the long dimension defined by the front panel 104 and the rear panel. In some embodiments, the second portion 146 may be between the first portion 144 and the third portion 148 spatially separating the first portion 144 and the third portion 148. The layout may approximate the pre-filled syringe 200 and the transfer needle 220 and approximate the dosing syringe 260 and the dosing needle 270 to clarify that the pre-filled syringe 200 and the transfer needle 220 are to be used together and the dosing syringe 260 and the dosing needle 270 are to be used together. The layout may spatially separate the pre-filled syringe 200 and the dosing syringe 260 and spatially separate the transfer needle 220 and the dosing needle 270 to prevent confusion of the user in the operation of each component. Furthermore, the first portion 144 may be on a left side of the tray 130, the second portion 146 may be on a central portion of the tray 130, and the third portion 148 may be on a right side of the tray 130, when the container 102 is opened by the user in a proper orientation (for example indicated by the orientation of text). Furthermore, the third compartment 136 may be above the fourth compartment 138, and a central axis of the third compartment 136 may be shifted laterally toward the first portion 144 relative to a central axis of the fourth compartment 138. Thus, the spatial layout of the components may indicate to the user to first remove the pre-filled syringe 200 and the transfer needle 220 from the tray 130, followed by the vial 230 and then the vial adapter 240, and then the dosing syringe 260 and the dosing needle 270.

[0091] An additional or alternative indication of the order of operation may be the orientation of one or more of the components in the respective compartments. In some embodiments, the prefilled syringe 200 and / or the transfer needle 220 may be more prominently displayed in the tray 130 than the dosing syringe 260 and / or the dosing needle 270 to indicate to the user that the prefilled syringe 200 and the transfer needle 220 should be used first. For example, the dosing syringe 260 and / or the dosing needle 270 may each be disposed in an individual packaging, for example in a blister pack. The blister pack may include a backing and a shell. The backing may be a foil, paper, and / or cardboard forming a back portion of the blister pack, and the shell may be made of a clear semi-rigid plastic protruding from the backing and forming a front portion of the blister pack.The individual packaging for one or more of the components may form a substantially rectangular shape having a shorter axis and a longer axis, for example defined by a planar surface of the backing of the packaging. The individual packaging of the dosing syringe 260 and / or the dosing needle 270 may be placed on its side, such that the backing extends vertically through the respective compartment to reduce visibility while positioned in the tray 130 to the user. Thus, only the side profile of the packaging would be visible to the user upon opening of the container 102, making the dosing syringe 260 and / or the dosing needle 270 less prominent in the tray 130. On the other hand, the transfer needle 220 and / or the vial adapter 240 may be oriented in the tray 130 with the backing in a horizontal orientation with the back of the backing laying flat on the bottom of the respective compartment 134, 138, such that substantially the entire shell and / or component may be visible to the user when opening the container 102, making the transfer needle 220 and / or the vial adapter 240 more prominent to the user. Thus, the individual packaging of the transfer needle 220 and / or the vial adapter 240 may have a different orientation than the individual packaging of the dosing syringe 260 and / or the dosing needle 270 to display the transfer needle 220 and / or the vial adapter 240 more prominently than the dosing syringe 260 and / or the dosing needle 270, as illustrated in FIGS. 1 and 3.

[0092] The kit 100 may, additionally or alternatively, include one or more indicia printed, formed, or otherwise disposed on or overlaying the tray 130 (z.e., on the insert 150) that visually groups the components of the medicament delivery system and / or indicates an order of operation of the components. The one or more indicia may include distinct colors, lines, letters, numbers, patterns, ribs, and / or grooves. The kit 100 may have a first indicia associated with the first group of components of the medicament delivery system and a second indicia associated with the second group of components of the medicament delivery system. For example, the first indicia corresponds to components of the kit 100 associated with reconstitution of the medicament, whereas the second indicia corresponds to components of the kit 100 associated with delivery of the medicament. The first indicia may embody a first color and / or pattern and the second indicia may embody a second color and / or pattern, where the first color and / or pattern and the second color and / or pattern are different. For example, the first indicia may be purple and the second indicia may be orange, however any distinct set of colors may be used. The first indicia may, additionally or alternatively, embody one or more first lines forming one or more rings 152, 154, and the second indicia may further include one or more second lines forming one or more second rings 156, 158. Thus, the first indicia may include at least one first ring 152, 154 of the first color and / or pattern disposed at least partially around at least one of the first compartment 132, the second compartment 134, and the third compartment 136. As illustrated, the at least one first ring 152, 154 may include a ring 152 around the first compartment 132 and the second compartment 134 and a ring 154 around the third compartment 136. The ring 152 extending around both the first compartment 132 and the second compartment 134 may be due to space conservation in joining ofthe first compartment 132 and the second compartment 134, while facilitating grasping of the components by orienting the first compartment 132 and the second compartment 134 in communication with each other, as discussed above. However, in alternative embodiments, the second compartment 134 and the third compartment 136 may be encircled by distinct rings 154. The second indicia may similarly include at least one second ring 156, 158 disposed at least partially around at least one of the fourth compartment 138, the fifth compartment 140, and the sixth compartment 142. The at least one second ring may include a ring 156 around the fourth compartment 138 and a ring 158 around the fifth compartment 140 and the sixth compartment 142. The ring 158 extending around both the fifth compartment 140 and the sixth compartment 142 may be due to space conservation in joining of the fifth compartment 140 and the sixth compartment 142, while facilitating grasping of the components by orienting the fifth compartment 140 and the sixth compartment 142 in communication with each other, as discussed above. However, in alternative embodiments, the fifth compartment 140 and the sixth compartment 142 may be encircled by distinct rings 158. In some embodiments, the rings 152-158 may be raised forming a lip around the compartments 162-72 that physically and visually guides the components in each of the compartments 132-142. Each of the rings 152-158 may be continuous or discontinuous (e.g., formed by a dashed or broken line). As illustrated in FIGS. 1, 3, and 4, the first indicia may include a first hatching or cross-hatching pattern and / or the second indicia may include a second hatching or cross-hatching pattern, where the first hatching or cross-hatching pattern is different from the second hatching or cross-hatching pattern.

[0093] The indicia may, additionally or alternatively, include symbols 170 associated with the components indicating the order of operation. The symbols 170 may include letters and / or numbers sequentially and / or progressively associated with the components based on the order of operation. The numbers may include natural numbers, integers, roman numerals, triangular numbers, decimals, fractions, and / or dot accumulations. The letters may be based on an alphabet of any language, including the English alphabet, the Latin alphabet, and / or the Greek alphabet. The symbols 170 may, additionally or alternatively, include warning signs cautioning the user on the use of the pre-filled syringe 200 containing the diluent 201 and / or the vial 230 containing the medicament, due to the pre-filled nature. An arrow or line 172 may extend between and / or visually connect the symbol 170 and the respective compartment. The symbols 170 and / or line 172 may be coded based on the first and second indicia, such as in the first color and / or pattern and the second color and / or pattern. For example, the first compartment 132 may be indicated by a symbol 170 comprising a number “1” in the first color and / or pattern, the second compartment 134 may be indicated by a symbol 170 comprising a number “2” in the first color and / or pattern, and the third compartment 136 may be indicated by a symbol 170 comprising a number “3” in the first color. The fourth compartment 138 may be indicated by a symbol 170 comprising a number “4” in the second color and / or pattern, the fifth compartment 140 may be indicated by a symbol 170comprising a number “5” in the second color and / or patern, and the sixth compartment 142 may be indicated by a symbol 170 comprising a number “6” in the second color and / or patern.

[0094] The indicia may be formed, printed, or otherwise disposed on the insert 150 positioned in the container 102 overlying the tray 130. The insert 150 may be a standalone flat sheet or panel, as illustrated in FIG. 4. Alternatively, the insert 150 may be a flat sheet or panel of a three- dimensional structure, such as a sleeve that receives the tray 130 as illustrated in FIG. 18. The insert 150 may be attached to the tray 130, such as through adhesive, or rest upon the surface of the tray 130. In some embodiments, the insert 150 may be omited or be a part of the tray 130, such that the indicia may be formed or printed directly on the tray 130 itself. The insert 150 may, additionally or alternatively, be directly atached to the container 102, such as being pivotably atached to the front panel 104, as illustrated with a central panel 416 in FIGS. 19-20. The insert 150 may be made of paper of a card stock or plastic, and the tray 130 may be made of a plastic, Paperfoam, or a Styrofoam material.

[0095] The lid 108 may have an inner surface that is exposed to the user when the container 102 is opened. The inner surface may have a first region 174 including information associated with the first group of components, such as the pre-filled syringe 200, the transfer needle 220, and / or the vial 230, for example including instructions for preparing the medicament. The inner surface may have a second region 176 including information associated with the second group of components including the vial adapter 240, the dosing syringe 260, and / or the dosing needle 270, for example including instructions for administering the medicament. The first region 174 may include the first indicia similar to the insert 150, and the second region 176 may include the second indicia similar to the insert 150. As illustrated, the first region 174 may include a one or more first lines 175 forming a box around the instructions for preparing the medicament, where the one or more lines175 may be correlated to the first indicia of the insert 150 (e.g., matching the first ring 152, 154). The second region 176 may include a one or more second lines 177 forming a box around the instructions for administering the medicament, where the one or more lines 177 may be correlated to the second indicia of the insert 150 (e.g., matching the second ring 156, 158). The line(s) 175 of the first region 174 may be the first color and / or patern and the line(s) 177 of the second region176 may be the second color and / or patern. When the lid 108 is opened, the first region 174 may be substantially aligned with the first compartment 132, the second compartment 134, and / or the third compartment 136, and the second region 176 may be substantially aligned with the fourth compartment 138, the fifth compartment 140, and / or the sixth compartment 142. Thus, the user may readily associate the information from the first region 174 of the lid 108 with the first group of components and the information from the second region 176 of the lid 108 with the second group of components. The information from the first region 174 and the second region 176 may provide a quick reference guide to the user.

[0096] In some embodiments, as illustrated in FIG. 26, the second region 176 may include a printed or textured swatch 596 that may visually communicate optimal and / or suboptimal consistencies of the reconstituted medicament. For example, the swatch 596 may illustrate color variations of the reconstituted medicament to indicate the grades for various optimal and / or suboptimal consistencies. The swatch 596 may include one or more bands of color visually indicating a consistency of the reconstituted medicament that is graded to be very good, good, fair, lightly dehydrated, dehydrated, very dehydrated, and / or severely dehydrated. The swatch 596 may be especially useful for a medicament like olanzapine that has a clear color variation based on reconstitution.

[0097] As illustrated in FIG. 5 and FIG. 6, the pre-fdled syringe 200 may include a syringe body 202 and a plunger rod 204. The syringe body 202 may have a syringe barrel 207 extending from a proximal end to a distal end along a longitudinal direction. The syringe body 202 may further have a syringe tip 203 on a distal portion, a flange 205 on a proximal portion and a shoulder 209, where the shoulder 209 extends between the syringe tip 203 and the syringe barrel 207, and the syringe barrel 207 extends between the shoulder 209 and the flange 205. The syringe barrel 207 may be substantially tubular or cylindrical having an inner surface extending along the longitudinal direction to define a chamber. The syringe barrel 207 may include a lubricant coating on the inner surface. For example, the lubricant can be a silicone oil, an example of which is polydimethylsiloxane. In an embodiment, the syringe may contain at most 1.0 mg of the lubricant. However, it is also contemplated that the syringe may contain at most 0.9 mg, 0.8 mg, 0.7 mg, 0.6 mg, 0.5 mg, 0.4 mg, 0.3 mg, 0.2 mg, or 0. 1 mg of the lubricant. In an embodiment, the lubricant is applied to the syringe via spraying. However, other methods of lubricant application are contemplated.

[0098] The chamber may be configured to store the diluent 201 for dispensing through a distal opening of the syringe tip 203. The syringe body 202 can have a length Li measured longitudinally from the proximal end of the flange 205 to the distal end of the syringe tip 203 and the syringe barrel 207 may have a length L2 measured longitudinally from the proximal end of the flange 205 to the proximal end of the shoulder 209. In an embodiment, the length Li may be 55 mm to 80 mm. In other embodiments, the length Li may be 60 mm to 75 mm, or 65 mm to 70 mm. In additional embodiments, the length Li may be 65 mm, 66 mm, 67 mm, 68 mm, 69 mm, or 70 mm. In a particular embodiment, the length Li may be 66.8 mm. In an embodiment, the length L2 may be 45 mm to 65 mm. In other embodiments, the length L2 may be 48 mm to 62 mm, or 50 mm to 60 mm, or 52 mm to 58 mm. In additional embodiments, the length L2 may be 52 mm, 53 mm, 54 mm, 55 mm, 56 mm, or 57 mm. In a particular embodiment, the length L2 may be 54.40 mm.

[0099] The syringe barrel 207 may also define a substantially constant outer diameter D (i.e. , between the shoulder 209 and the flange 205). In an embodiment, the outer diameter D may be 10.50 mm to 11.50 mm. In other embodiments, the outer diameter D may be 10.75 mm to 10.95mm or 10.80 mm to 10.90 mm. In a particular embodiment, the outer diameter D may be 10.85 mm. The syringe barrel 207 may also define a wall thickness T (z.e., between the shoulder 209 and the flange 205). However, it is also contemplated that the entire syringe body 202 may have a constant wall thickness throughout a substantial entirety of its length. In an embodiment, the wall thickness T may be 0.8 to 1.4, or 0.9 mm to 1.3 mm, or 1.0 mm to 1.2 mm. In additional embodiments, the thickness T may be 1.0 mm, 1.1 mm, or 1.2 mm. As described further below, the diluent 201 stored within the pre-filled syringe 200 may require defrosting from a frozen state. In comparison to other conventional pre-filled syringes of a comparable size (capacity), the relatively small outer diameter T of the barrel 207 may provide for a relatively high surface area to volume ratio, which may allow thermal energy to be transferred to the diluent 201 stored within the pre-filled syringe at a relatively faster rate for defrosting purposes. The relatively small wall thickness T may also assist in this regard.

[0100] The syringe body 202 may be formed of glass. In an embodiment, the glass may be borosilicate glass. As described further below, the diluent 201 stored within the pre-filled syringe 200 may require defrosting from a frozen state. In comparison to other conventional pre-filled syringe materials (z.e., polymers), glass is a better thermal conductor. Whereas polymers typically used for syringes (polypropylene, polycarbonate, polyethylene, etc.) have a thermal conductivity of between about 0.1 to 0.3 W / m-K, glass, such as borosilicate glass, has a thermal conductivity of about 1.1 W / m-K or higher. As such, utilizing glass as opposed to polymer for the pre-filled syringe 200 can enable more effective heat transfer from a room temperature environment and / or a warming pack 280 (as described further below), and thus quicker defrosting of the diluent 201.

[0101] A cap 206 may releasably cover the syringe tip and seal the diluent. The plunger rod 204 may be an elongated body and have a flange at a proximal end configured to be actuated. The plunger rod 204 may have a stopper 208 at a distal end for sealing the proximal end of the chamber and be configured to push the diluent 201 from the chamber and into the vial 230.

[0102] The diluent 201 may include an organic solvent. Organic solvents suitable for use in compositions of this disclosure include benzyl alcohol, benzyl benzoate, diethylene glycol dimethyl ether (Diglyme), diethylene glycol monoethyl ether (DEGMEE), dimethyl isosorbide (DMI), dimethyl sulfoxide (DMSO), ethyl acetate, ethyl benzoate, ethyl lactate, ethylene glycol monoethyl ether acetate, glycerol formal, methyl ethyl ketone, methyl isobutyl ketone, N-ethyl-2 -pyrrolidone, N-methyl-2-pyrrolidinone (NMP), pyrrolidone-2, tetraglycol, triacetin, tributyrin, tripropionin, or triethylene glycol dimethyl ether (triglyme), or mixtures of the foregoing solvents. In an embodiment, the diluent 201 may include dimethyl sulfoxide (DMSO), N-methyl-2-pyrrolidinone (NMP), or a mixture thereof. The diluent 201 may include dimethyl sulfoxide (DMSO).

[0103] The diluent 201 may comprise from 70 wt% to 85 wt% of the organic solvent. In some embodiments, the diluent may comprise from 70 wt% to 80 wt% of the organic solvent, 73 wt% to 80 wt% of the organic solvent, 71 wt% to 79 wt% of the organic solvent, 72 wt% to 78 wt% of theorganic solvent, or 73 wt% to 77 wt% of the organic solvent. In some embodiments, the diluent may comprise greater than 70 wt% of the organic solvent, or greater than 71 wt%, greater than 72 wt%, greater than 73 wt%, greater than 74 wt%, greater than 75 wt%, greater than 76 wt%, greater than 77 wt%, greater than 78 wt%, greater than 79 wt%, or greater than 80 wt% of the organic solvent.

[0104] The diluent 201 may further include a pharmaceutically acceptable excipient of a polymer and / or non-polymer. In some embodiments, the excipient comprises a polymer, which may be a biodegradable polymer comprising poly(lactide), poly (glycolide), poly(lactide-co- glycolide), poly(lactic acid), poly(L-lactic acid, poly(D-lactic acid, poly(D,L-lactic acid), polyethylene glycol) or end capped variants or a copolymer of one or more of the foregoing, poly(aliphatic carboxylic acids), copolyoxalates, polycaprolactone, polydioxanone, poly(o / 7 / ?o carbonates), poly(acetals), poly(lactic acid-co-caprolactone), poly or Koesters, poly(glycolic acid- co-caprolactone), poly(amino acid), polyesteramide, polyanhydrides, polyphosphazines, poly(alkylene alkylate), biodegradable polyurethane, polyvinylpyrrolidone, polyalkanoic acid, albumin, chitosan, casein, or waxes, or blends and / or copolymers thereof.

[0105] In an embodiment, the biodegradable polymer excipient may include a triblock copolymer and a diblock copolymer. For example, the biodegradable polymer excipient may include a diblock copolymer comprising polylactic acid (PLA) and polyethylene glycol (PEG) and having a number average molecular weight of 6 to 15 kg / mol and comprising 70% - 90% by weight (w / w) polylactic acid; and a triblock copolymer comprising polylactic acid (PLA) and polyethylene glycol (PEG) and having a number average molecular weight of 6 to 19 kg / mol and comprising 80% - 90% by weight (w / w) polylactic acid.

[0106] The polylactic acid (PLA) in the diblock copolymer may be composed of randomly distributed D-lactic acid and L-lactic acid monomeric units. The polyethylene glycol (PEG) in the diblock copolymer may be capped at one end by a Ci-Ce alkyl group, such as, for example -CHs, - CH2CH3, and the like. That is, the terminal hydroxyl group at one end of the polyethylene glycol (PEG) chain may be capped with a Ci-Ce alkyl group, and the terminal hydroxyl group at the other end of the PEG chain forms an ester bond to the polylactide (PLA) chain. In some embodiments, the polyethylene glycol (PEG) in the diblock copolymer is capped at one end by -CH3. Such capped PEG may be designated as mPEG. That is, the terminal hydroxyl group at one end of the polyethylene glycol (PEG) chain is capped with -CH3, and the terminal hydroxyl group at the other end of the PEG chain forms an ester bond to the polylactide (PLA) chain. The diblock copolymer may be obtained by ring -opening polymerization of D,L-lactide initiated by the terminal hydroxyl group of the mPEG chain.

[0107] In some aspects, the diblock copolymer in the compositions of the present disclosure has the following structure:

[0108]

[0109] wherein n is the number of ethylene oxide units in the PEG, and m is the number of lactic acid units in the PLA. The theoretical molecular weight of the diblock copolymer can be calculated using the molar masses of lactic acid unit (M(LA) = 72 g / mol) and ethylene oxide unit (M(E0) = 44 g / mol) and the number of repeat units of each block as follow: M(mPEG-PLA) = n * 44 + m * 72 + 32. Typically, the diblock copolymer in the composition of the disclosure has a theoretical molecular weight of 6 to 15 kg / mol. In one embodiment, the diblock copolymer has a theoretical molecular weight of 8.0 to 12.5 kg / mol or 6.0 to 9.5 kg / mol.

[0110] In some embodiments, the triblock copolymer in the compositions of the disclosure is an A-B-A copolymer in which the A groups are polylactic acid and the B group is polyethylene glycol (PEG). In these embodiments, the terminal hydroxyl group at either end of the polyethylene glycol (PEG) chain forms an ester bond to the polylactide (PLA) chain. The triblock copolymer may be obtained by ring -opening polymerization of D,L-lactide initiated by the terminal hydroxyl group of the PEG chain.

[0111] In some aspects, the triblock copolymer in the compositions of the present disclosure has the structure:

[0112]

[0113] wherein n is the number of ethylene oxide units in the PEG, and each m is the number of lactic acid units in the PLA group to which it refers. The theoretical molecular weight of the triblock copolymer can be calculated using the molar masses of lactic acid unit (M(LA), 72 g / mol) and ethylene oxide unit (M(E0), 44 g / mol) and the number of repeat units of each m positions of the disclosure has a theoretical molecular weight of 6 to 19 kg / mol. In one embodiment the triblock copolymer has a theoretical molecular weight of 6.5 to 9.0 kg / mol or 10.0 to 17.0 kg / mol.

[0114] The diluent 201 may comprise from 15 wt% to 30 wt% of the biodegradable polymer excipient. In some embodiments, the diluent may comprise from 20 wt% to 30 wt% of the biodegradable polymer excipient, or from 20 wt% to 27 wt% of the biodegradable polymer excipient, or from 11 wt% to 19 wt% of the biodegradable polymer excipient, or from 12 wt% to18 wt% of the biodegradable polymer excipient, or from 13 wt% to 17 wt% of the biodegradable polymer excipient.

[0115] The pre-fdled syringe 200 may contain about 0.73-2.5 grams of the diluent 201. In some embodiments, the pre-fdled syringe 200 may contain about 1.3-2.5 grams of the diluent 201. In other embodiments, the pre-fdled syringe 200 may contain about 0.9-2.1 grams of the diluent 201. In further embodiments, the pre-fdled syringe may contain 0.73, 0.8, 0.9, 1.0, 1.1, 1.2, 1.26, 1.3,1.4, 1.5, 1.50, 1.6, 1.7, 1.74, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, or 2.5 grams of the diluent. The diluent 201 may comprise an organic solvent, a diblock copolymer, or a triblock copolymer. In another embodiment, the diluent 201 may comprise a mixture of organic solvent, a diblock copolymer, and a triblock copolymer.

[0116] In some aspects, the diluent 201 may comprise about 0.73 - about 2.5 grams, optionally about 1.3 - about 2.5 grams, of the diluent 201, such as, for example, about 0.73, about 0.8, about 0.9, about 1.0, about 1.1, about 1.2, about 1.26, about 1.3, about 1.4, about 1.5, about 1.50, about 1.6, about 1.7, about 1.74, about 1.8, about 1.9, about 2.0, about 2.1, about 2.2, about 2.3, about2.4, or about 2.5 grams of the diluent.

[0117] In some aspects, the diluent 201 may comprise 0.73 - 2.5 grams of a mixture of an organic solvent that is dimethyl sulfoxide (DMSO), N-methyl-2-pyrrolidinone (NMP), or a combination thereof, a diblock copolymer comprising polylactic acid and polyethylene glycol and having a number average molecular weight of 6.5 to 15 kg / mol and comprising 70% - 90% by weight (w / w) of polylactic acid, and a triblock copolymer comprising polylactic acid and polyethylene glycol and having a number average molecular weight of 7 to 15 kg / mol and comprising 80% - 90% by weight (w / w) of polylactic acid. The organic solvent may be dimethyl sulfoxide (DMSO).

[0118] In some embodiments, the pre-fdled syringe 201 containing the mixture of organic solvent, the diblock copolymer, and the triblock copolymer contains about 0.73 grams of the mixture.

[0119] In some embodiments, the pre-fdled syringe 201 containing the mixture of organic solvent, the diblock copolymer, and the triblock copolymer contains about 1.4 grams of the mixture.

[0120] In some embodiments, the pre-fdled syringe 201 containing the mixture of organic solvent, the diblock copolymer, and the triblock copolymer contains about 1.5 grams of the mixture.

[0121] In some embodiments, the pre-fdled syringe 201 containing the mixture of organic solvent, the diblock copolymer, and the triblock copolymer contains about 1.7 grams of the mixture.

[0122] In some embodiments, the pre-filled syringe 201 containing the mixture of organic solvent, the diblock copolymer, and the triblock copolymer contains about 2.0 grams of the mixture.

[0123] The diluent 201 may have a melting point above 8°C, such that the diluent is in a frozen, solid state when stored in a refrigerated environment (2°C to 8°C). For example, the diluent may have a melting point of about 12°C to 18°C.

[0124] The diluent 201 may increase the shelf life of the medicament after reconstitution, facilitating administration. In embodiments, the diluent may comprise an organic solvent in the form of dimethyl sulfoxide (DMSO), which has been found to inhibit microbial activity of the reconstituted medicament. The shelflife of the reconstituted medicament at room temperature may thus be 24 hours for example when the organic solvent is present in the reconstituted medicament in a percent weight with respect to the total weight of the reconstituted medicament as described herein. Further discussion of the diluent 201 is provided in WO2023 / 139531A1 and / or US2024 / 0238308A1, as expressly incorporated herein by reference.

[0125] As further illustrated in FIG. 5, the transfer needle 220 may include a hub 222 configured to be attached to the distal end of the pre-filled syringe 200, for example through a Luer connection. A hollow needle 224 may extend from the hub 222. A needle shield 226 may releasably cover the hollow needle 224 and retain the hollow needle 224 in a sterile state prior to use. In use, the hub 222 may be attached to the distal end of the pre-filled syringe 200, the needle shield 226 may be removed to expose the hollow needle 274, and the hollow needle 274 may then be used to pierce a septum 238 of the vial 230 and introduce the diluent 201 into the vial 230. After use, the needle shield 226 may be reattached to the hub 222 to cover the hollow needle 224 for disposal. The transfer needle 220 may additionally include a safety shield 278, as further discussed with regard to the dosing needle 270.

[0126] The vial 230 may include a bottle 232 having a neck 234 and a crown 236 with an opening sealed by a septum 238. The bottle 232 may contain the medicament in a lyophilized or powder state prior to reconstitution. The septum 238 may be composed of a rubber puncturable by the hollow needle 224 of the transfer needle 220. The pre-filled syringe 200 may then introduce the diluent 201 through the hollow needle 224 into the bottle 232 to reconstitute the medicament. The septum 238 may self-seal upon removal of the hollow needle 224. The hollow needle 224 may be 21 gauge to accommodate the viscosity of the diluent 201 while preventing microparticle generation during puncturing the septum 238 and also minimizing the opening of the septum 238 generated by the puncturing to allow for resealing. After reconstitution, the vial adapter 240 may be snapped over the crown 236 onto the neck 234 for removal of the reconstituted medicament from the vial 230. In some embodiments, as illustrated in FIG. 6, the vial adapter 240’ may be attached the vial 230 before introduction of the diluent 201 into the vial 230 and be retained on the vial 230 during reconstitution, such that the vial adapter 240’ may be used to introduce the diluent 201 andthen remove the reconstituted medicament. The vial adapter 240’ may thus, in some embodiments, replace the function of the transfer needle 220, and the transfer needle 220 may be omitted from the kit 100.

[0127] The medicament may include olanzapine or a pharmaceutically acceptable salt thereof having at least one of the following properties: a particle size distribution characterized by a D(90) of from about 20 to about 37 pm, or a particle size distribution characterized by a D(3,2) of from about 5.5 to about 7.5 pm, or a tapped density from about 0.35 to 0.44 g / ml; or any combination thereof. The olanzapine or a pharmaceutically acceptable salt thereof exhibits a flow function of about 2.0 or less and / or an RSD of fdling weight (%) of about 1.5% or less and / or a fdling speed of 14% or higher. In some embodiments, the olanzapine or a pharmaceutically acceptable salt thereof exhibits a flow function of about 2.0 or less or from about 1.0 to about 2.0, or from 1.4 to about 2.0. In some embodiments, the olanzapine or a pharmaceutically acceptable salt thereof exhibits an RSD of fdling weight (%) of about 1.5% or less or about from 1.0% to about 1.5%. In some embodiments, the olanzapine or a pharmaceutically acceptable salt thereof exhibits a fdling speed of 14% or higher or about 14% to about 20%. In some embodiments the olanzapine is olanzapine base. In some embodiments the olanzapine is an olanzapine salt. In some embodiments, the olanzapine is olanzapine polymorph. In some embodiments, the olanzapine is olanzapine Form II.

[0128] The term “olanzapine”, refers to the compound having the chemical name 2-methyl-4-(4- methyl-l-piperazinyl)-10H-thieno[2,3-b] [l,5]benzodiazepine and the chemical structure:

[0129]

[0130] The vial 230 may contain from about 318 mg to about 950 mg of olanzapine or a pharmaceutically acceptable salt of olanzapine. In some embodiments, the vial 230 may contain from about 400 mg to about 950 mg of olanzapine or a pharmaceutically acceptable salt of olanzapine, or from about 550 mg to about 950 mg of olanzapine or a pharmaceutically acceptable salt of olanzapine, or from about 450 mg to about 800 mg of olanzapine or a pharmaceutically acceptable salt of olanzapine.

[0131] In some aspects, the kits of the disclosure comprise a container containing 318 mg - 950 mg, optionally 400 - 900 mg, optionally 450 mg - 800 mg of olanzapine, such as, for example, 318 mg, 320 mg, 325 mg, 330 mg, 335 mg, 340 mg, 345 mg, 350 mg, 355 mg, 360 mg, 365 mg, 370 mg, 375 mg, 380 mg, 385 mg, 390 mg, 395 mg, 400 mg, 405 mg, 410 mg, 415 mg, 420 mg, 425mg, 430 mg, 435 mg, 440 mg, 445 mg, 450 mg, 455 mg, 460 mg, 465 mg, 470 mg, 475 mg, 480 mg, 485 mg, 490 mg, 495 mg, 500 mg, 505 mg, 510 mg, 515 mg, 520 mg, 525 mg, 530 mg, 531 mg, 535 mg, 540 mg, 545 mg, 550 mg, 555 mg, 560 mg, 565 mg, 570 mg, 575 mg, 580 mg, 585 mg, 590 mg, 595 mg, 600 mg, 605 mg, 610 mg, 615 mg, 620 mg, 625 mg, 630 mg, 635 mg, 637 mg, 640 mg, 645 mg, 650 mg, 655 mg, 660 mg, 665 mg, 670 mg, 675 mg, 680 mg, 685 mg, 690 mg, 695 mg, 700 mg, 705 mg, 710 mg, 715 mg, 720 mg, 725 mg, 730 mg, 735 mg, 740 mg, 743 mg, 745 mg, 750 mg, 755 mg, 760 mg, 765 mg, 770 mg, 775 mg, 780 mg, 785 mg, 790 mg, 795 mg, 800 mg, 805 mg, 810 mg, 815 mg, 820 mg, 825 mg, 830 mg, 835 mg, 840 mg, 845 mg, 850 mg, 855 mg, 860 mg, 865 mg, 870 mg, 875 mg, 880 mg, 885 mg, 890 mg, 895 mg, 900 mg, 905 mg, 910 mg, 915 mg, 920 mg, 925 mg, 930 mg, 935 mg, 940 mg, 945 mg, or 950 mg of olanzapine.

[0132] In some aspects, the kits of the disclosure comprise a container containing about 318 mg - about 950 mg, optionally about 550 - 950 mg, optionally 450 mg - 800 mg of olanzapine, such as, for example, about 318 mg, about 320 mg, about 325 mg, about 330 mg, about 335 mg, about 340 mg, about 345 mg, about 350 mg, about 355 mg, about 360 mg, about 365 mg, about 370 mg, about 375 mg, about 380 mg, about 385 mg, about 390 mg, about 395 mg, about 400 mg, about 405 mg, about 410 mg, about 415 mg, about 420 mg, about 425 mg, about 430 mg, about 435 mg, about 440 mg, about 445 mg, about 450 mg, about 455 mg, about 460 mg, about 465 mg, about 470 mg, about 475 mg, about 480 mg, about 485 mg, about 490 mg, about 495 mg, about 500 mg, about 505 mg, about 510 mg, about 515 mg, about 520 mg, about 525 mg, about 530 mg, about 531 mg, about 535 mg, about 540 mg, about 545 mg, about 550 mg, about 555 mg, about 560 mg, about 565 mg, about 570 mg, about 575 mg, about 580 mg, about 585 mg, about 590 mg, about 595 mg, about 600 mg, about 605 mg, about 610 mg, about 615 mg, about 620 mg, about 625 mg, about 630 mg, about 635 mg, about 637 mg, about 640 mg, about 645 mg, about 650 mg, about 655 mg, about 660 mg, about 665 mg, about 670 mg, about 675 mg, about 680 mg, about 685 mg, about 690 mg, about 695 mg, about 700 mg, about 705 mg, about 710 mg, about 715 mg, about 720 mg, about 725 mg, about 730 mg, about 735 mg, about 740 mg, about 743 mg, about 745 mg, about 750 mg, about 755 mg, about 760 mg, about 765 mg, about 770 mg, about 775 mg, about 780 mg, about 785 mg, about 790 mg, about 795 mg, about 800 mg, about 805 mg, about 810 mg, about 815 mg, about 820 mg, about 825 mg, about 830 mg, about 835 mg, about 840 mg, about 845 mg, about 850 mg, about 855 mg, about 860 mg, about 865 mg, about 870 mg, about 875 mg, about 880 mg, about 885 mg, about 890 mg, about 895 mg, about 900 mg, about 905 mg, about 910 mg, about 915 mg, about 920 mg, about 925 mg, about 930 mg, about 935 mg, about 940 mg, about 945 mg, or about 950 mg of olanzapine.

[0133] In some aspects of the kit, the vial 230 may contain a pharmaceutically acceptable salt of olanzapine in the amount equivalent to 318 mg to about 950 mg of olanzapine free base. In other embodiments, the vial 230 may contain a pharmaceutically acceptable salt of olanzapine in theamount equivalent to 550 mg to about 950 mg of olanzapine free base or about 450 to about 800 mg of olanzapine free base.

[0134] Further discussion of the medicament is further provided in WO2023 / 139531A1 and / or US2024 / 0238308A1, as expressly incorporated herein by reference. In some embodiments, the vial 230 may be individually packaged in its own box for shaking and / or mixing during reconstitution.

[0135] As illustrated in FIG. 5, the vial adapter 240 may include a first housing 242 and a second housing 244. The first housing 242 and the second housing 244 may be permanently secured to each other by an ultrasonic weld, an adhesive, and / or a mechanical attachment, and in some embodiments, the first housing 242 and the second housing 244 may be integrally formed as one-piece component, such as through injection molding. The first housing 242 and the second housing 244 may define a lumen 245 therebetween to transfer fluid between a syringe (e.g., the dosing syringe 260) and the vial 230. In embodiments, the vial adapter 240 may be valve-less, such that the vial adapter 240 does not have a component coupled to the lumen 245 impeding the flow therethrough. In some embodiments, as illustrated in FIGS. 6-9, the vial adapter 240’ may have a valve 246’, and the first housing 242 and the second housing 244 may receive the valve 246’ in the lumen 245. The valve 246’ may be self-sealing. The vial adapter 240 and the vial adapter 240’ may be identical except for the valve 246’ in the vial adapter 240’.

[0136] As illustrated in FIGS. 7-9, the first housing 242 may be substantially tubular and have an opening 248 that receives a tip of a syringe, such as the dosing syringe 260. The opening 248 may be in an upper portion 249 in the first housing 242. The upper portion 249 may be threaded to releasably secure a distal end of the pre-filled syringe 200 and / or the dosing syringe 260 to the vial adapter 240. The second housing 244 may have a skirt 250 that extends downwardly for telescopic mounting over the crown 236 and the neck 234 of the vial 230. The skirt 250 may have an upper surface 259 extending at a first angle relative to the longitudinal axis of the vial adapter 240 and a circumferential wall 251 extending at a second angle relative to the longitudinal axis of the vial adapter 240. The circumferential wall 251 may surround a cannula 252 configured to puncture the septum 238 of the vial 230. The cannula 252 may have a lumen in fluid communication with the lumen 245. The cannula 252 may terminate at a distal point positioned proximal to the distal end of the skirt 250. The skirt 250 may include one or more lugs 253 extending inwardly to snap over the crown 236 and onto the neck 234 of vial 230 to releasably retain the vial 230 to the vial adapter 240 with the cannula 252 puncturing the septum 238. In some embodiments, the vial adapter 240 may be permanently attachable to the vial 230, such that the vial adapter 240 cannot removed from the vial 230 without breaking the vial adapter 240 (e.g., the lugs 253) and / or the vial 230. The one or more lugs 253 may be pivotably attached to an inner surface of the circumferential wall 251 of the skirt 250. The one or more lugs 253 may be configured to elastically deflect radially outwardly as the crown 236 passes through the skirt 250 and deflect back inwardly to fit underneath the crown236. Additionally or alternatively, the circumferential wall 251 may elastically radially expand and retract to retain the crown 236 of the vial 230 with the one or more lugs 253. One or more openings 254 may extend through the skirt 250. The one or more openings 254 may be longitudinally aligned with one or more of the lugs 253 for visibility purposes. As illustrated, the skirt 250 may have three lugs 253 and three openings 254 equidistantly spaced around the longitudinal axis of the skirt 250. However, it is contemplated that the skirt 250 may have more or less lugs 253 and openings 254 as desired. The skirt 250 may further have one or more ribs 255 extending longitudinally along an inner surface of the circumferential wall 251. The one or more ribs 255 may be radially spaced between adjacent lugs 253 and / or openings 254. The one or more ribs 255 may aid in guiding the second housing 244 as the vial adapter 240 engages the vial 230. The one or more openings 254 may extend substantially the entire longitudinal length of the circumferential wall 251 and through the upper surface 259 of the skirt 250. Each of the one or more openings 254 may have a width extending through at least about one twelfth of the circumference of the skirt 250, at least at the widest portion of opening 254. In some embodiments, each of the one or more openings 254 may extend at least about one tenth (or 30°) of the circumference of the skirt 250, at least at the widest portion of opening 254. In some embodiments, each of the one or more openings 254 may extend at least about one eighth (or 45°) of the circumference of the skirt 250, at least at the widest portion of opening 254. In some embodiments, each of the one or more openings 254 may extend for about one sixth (or 60°) of the circumference of the skirt 250, at least at the widest portion of opening 254.

[0137] As further illustrated in the embodiment of FIGS. 6-9, the valve 246’ may have a tubular body 256’ defining a lumen, a shoulder 257’ extending upwardly from the tubular body 256’, and an upper surface 258’ above the shoulder 257. The upper surface 258’ may be exposed through the opening 248. The upper surface 258’ may have a through-slit that is normally-closed to preclude fluid flow through the opening 248. The tip of the dosing syringe 260 may be inserted through the opening 248 of the first housing 242 and push the upper surface 258 downwardly and outwardly to buckle the tubular body 256. The lumen 245 of the vial adapter 240 may include a lateral recess 247 that receives outwardly deflected portions of the valve 246’ as the tubular body 256’ buckles. The buckling of the tubular body 256’ may open the slit on the upper surface 258’, and the slit may receive the tip of the syringe 260 to put the lumen of the syringe 260 in communication with the lumen of the valve 246’ and form a first seal around the periphery of the tip of the syringe 260. A second seal may be formed between an outer surface of the tip of the syringe 260 and an inner surface of the upper portion 249. Upon removal of the tip of the syringe from the opening, the elastomeric properties of the valve 246’ may resiliently return the upper surface 258 to its normally-closed position within the upper portion, such that the valve is self-sealing. The upper surface 258’ may be received by the opening 248 and / or be exposed through the opening 248 in its relaxed state for cleaning by allowing a user to swab the upper surface 258 for sterility purposes.

[0138] The vial adapter 240 may have a short fluid length from the fluid connection with the syringe 260 to the fluid connection with the vial 230 reducing fluid dead space and thus waste. The vial adapter 240 may be unvented, such that the lumen through the cannula 252 and the tubular body 256 is the only passage out of the vial 230 when attached to the vial adapter 240. The present inventors have found that when removing air from the vial 230 through a vented vial adapter with a syringe to equalize the pressure in the vial 230, the diluent 201 and / or medicament often floods the vents of the vial adapter. Thus, the vial adapter 240 may be unvented to avoid this possibility.

[0139] The vial adapter 240 may be made of one or more materials that is compatible with organic solvents, such as dimethyl sulfoxide (DMSO). For example, the first and second housings 242, 244 may be made of polyethylene, polypropylene, polypropylene copolymer, polyester, copolyester, polycarbonate, polymethylpentene, and copolymers thereof. In some embodiments, the first and second housings 242, 244 may be made of a copolyester (e.g., a Tritan™ copolyester) or other copolymer (e.g., a TOPAS® copolymer) for the compatibility with dimethyl sulfoxide (DMSO), to facilitate ultrasonic welding of the first and second housings 242, 244, and for a favorable cannula resistance to breakage. The valve 246’ may be made of silicone for the elastomeric properties and compatibility with dimethyl sulfoxide (DMSO).

[0140] Returning to FIG. 5, like the pre-filled syringe 200, the dosing syringe 260 may include a syringe body 262 and a plunger rod 264. The syringe body 262 may have a syringe barrel extending from a proximal end to a distal end along a longitudinal direction. The syringe body 262 may further have a syringe tip on a distal portion and a flange on a proximal portion. The syringe barrel may be substantially tubular or cylindrical having an inner surface extending along the longitudinal direction to define a chamber. The plunger rod 264 may be an elongated body and have a flange at a proximal end configured to be actuated. The plunger rod 264 may have a stopper 268 at a distal end for sealing the proximal end of the chamber. The chamber of the syringe body 262 may be empty when packaged in the container 102.

[0141] The dosing needle 270 may include a hub 272 configured to be attached to the distal end of the dosing syringe 260. A hollow needle 274 may extend from the hub 272. The dosing needle 270 may be a shielded needle. For example, a needle shield 276 may releasably cover the hollow needle 274 and retain the hollow needle 274 in a sterile state. The needle shield 276 may have a cutout that receives a safety shield 278 in a retracted configuration prior to use of the dosing needle 270. In use, the hub 272 may be attached to the dosing syringe 260, and the needle shield 276 may be removed to expose the hollow needle 274 to inject the medicament into the patient. After administration, the safety shield 278 may be extended over the hollow needle 274 to be safely disposed of. The safety shield 278 may have a one-hand design that can be extended using a thumb, a finger, or a flat surface. The safety shield 278 may lock into the extended configuration preventing re-exposure of the hollow needle 274 after user. The hollow needle 274 may be 21 gauge to be sufficient size to accommodate the viscosity of the reconstituted medicament, whilereducing discomfort to the patient. In alternative embodiments, the transfer needle 220 and the dosing needle 270 can be identical (e.g., 21 gauge or 19 gauge).

[0142] The warming pack 280 and the at least one sheet or booklet 190 may overlay the tray 130 and / or the insert 150 and be positioned in the container 102, underneath the lid 108 when closed. As illustrated in FIG. 2, the warming pack 280 and sheet(s) or booklet 190 may be positioned adjacent to each other in the container 102. The warming pack 280 may overlay at least part of the first compartment 132, the second compartment 134, and / or the third compartment 136. Removing the warming pack 280 from the tray 130 may uncover components of the first group including the pre-filled syringe 200, the transfer needle 220, and / or the vial 230. The sheet(s) or booklet 190 may overlay at least part of the fourth compartment 138, the fifth compartment 140, and / or the sixth compartment 142. Removing the sheet(s) or booklet 190 from the tray 130 may uncover components of the second group including the vial adapter 240, the dosing syringe 260, and / or the dosing needle 270. However, in alternative arrangements the positions of the warming pack 280 and the sheet or booklet 190 may be reversed. The warming pack 280 and / or the sheet(s) or booklet 190 may be laterally retained in place or supported by one or more ribs 192 extending from the tray 130 and / or the insert 150. The one or more ribs 192 may extend between the tray 130 and the lid 108 to prevent the warming pack 280 and / or the at least one sheet or booklet 190 from sliding laterally. For example, the one or more ribs 192 may be integrated into the tray 130 and extend upwardly through holes (not shown) of the insert 150. The insert 150, the warming pack 280 and / or sheet(s) or booklet 190 may be recessed inside of the container 102, such as in a space formed circumferentially inside of a raised peripheral edge or rim 194 of the tray 130. For example, the peripheral rim 194 may extend from an upper surface of the tray 130 and at least one of the ribs 192 may form a broken line extending inside of the peripheral rim 194 such that the ribs 192 and the peripheral rim 194 collectively form two or more recessed spaces. Thus, the peripheral rim 194 and the one or more ribs 192 may form a raised surface separating the warming pack 280 and sheet(s) or booklet 190 and define separate spaces for each of the warming pack 280 and sheet(s) or booklet 190. The warming pack 280 and sheet(s) or booklet 190 may be displayed to the user immediately when opening the lid 108 of the container 102.

[0143] Olanzapine may be for extended-release injectable suspension and the diluent 201 should be stored in an environment below 8°C (e.g., between 2°C and 8°C). At the prescribed storage conditions the active pharmaceutical ingredient (API, in this case olanzapine) is a yellow powder, and the diluent 201 is an opaque solid (having a melting point of about 12°C to 18°C). Prior to reconstitution, the diluent 201 needs to be conditioned above the storage temperature (e.g., at room temperature), and at those conditions, the diluent 201 is a clear, colorless liquid solution. After reconstitution of a medicament product (z.e., medicament substance powder with diluent), an opaque yellow suspension is obtained. Conventionally, the diluent may be brought up to room temperature by removing the diluent from refrigeration for a period of time (e.g. , an hour or more)and placed in the ambient environment prior to planned administration in order to allow for the diluent to defrost sufficiently to enable reconstitution. However, the substantial amount of time required for melting the diluent at ambient temperatures requires removing the diluent from refrigeration well prior to a planned patient appointment and administration. As a result, should a patient not attend a planned appointment, doses of the API may be wasted.

[0144] The warming pack 280 may be provided to expedite the defrosting of the diluent 201 from the solid state when stored in an environment between 2°C and 8°C. The warming pack 280 may warm the diluent to at least its melting point (e.g., about 12°C to 18°C) to defrost the diluent 201 in less than 30 minutes (e.g., about 10-15 minutes), while defrosting the diluent 201 at room temperature without the warming pack 280 may take up to 12 hours. The warming pack 280 may also warm the diluent to room temperature (e.g. , about 20°C to 25 °C) to defrost the diluent 201 in less than 30 minutes (e.g., about 10-15 minutes). The warming pack 280 may warm the diluent 201 to a temperature at or below body temperature (37°C). For example, the warming pack 280 may warm the diluent 201 to a temperature below body temperature (37°C), and the diluent 201 remains below body temperature prior to administration. This significantly reduced time for diluent warming allows for warming to commence after a patient has arrived for an appointment, significantly reducing the risk of unnecessarily wasted API. Additionally, it has been found that the increased rate of warming the diluent 201 using the warming pack 280 does not lead to a deterioration in product quality when compared to warming at room temperature, and in fact decreases the initiation force required to transfer the diluent 201 to the vial from the pre-filled syringe 200.

[0145] As illustrated in FIG. 10, the warming pack 280 may include an outer pouch 282 and an activator 284 contained in the outer pouch 282. The outer pouch 282 may also contain a solution of sodium acetate and water. The solution may comprise 70-90% (w / w) sodium acetate. The sodium acetate may be a supercooled liquid that can stay liquid at temperatures below its freezing point. The activator 284 may trigger the sodium acetate to spontaneously change from the liquid state to a solid state formed by sodium acetate crystals. The activator 284 may be a solid, flexible strip or disc having one or more fissures or slits extending therethrough. The activator 284 may be made of a ferrous material, e.g., a metal such as stainless steel. When flexed or bent, the activator 284 may cause the sodium acetate solution when supercooled to crystalize with ensuing evolution of heat into a hydrated salt. Flexing the activator 284 may produce minute continuances or extensions of fracturing to initiate crystallization, which radially emanates from the activator 284 throughout the outer pouch 282. In some embodiments, the activator 284 may be vented and initially contain solid particles of sodium acetate, such that the activator 284 may be bent and / or broken to expose and / or release the solid particles and trigger the reaction to solidify the solution. For example, manipulating or clicking the activator 284 may release a small number of crystals of sodium acetate which act as nucleation sites for the crystallization of the sodium acetate. Thisreaction is exothermic, releasing energy from the crystal lattice and producing heat, which can be used to defrost the diluent 201. In an embodiment, this exothermic reaction may cause the warming pack 280 to heat up to 30-45° C within a couple of minutes, and maintain an elevated temperature for up to 1.5 hours. In another embodiment, the warming pack 280 may heat up to 54° C and last 15-30 minutes. The outer pouch 282 may be polyvinyl chloride (PVC), polyethylene (PE), and / or nylon. In some embodiments, a portion of the activator 284 may be anchored to a portion of the warming pack 280, for example, bonded to an inner surface of the warming pack 280 with an epoxy resin that will not adversely affect the sodium acetate solution.

[0146] In another embodiment, the warming pack 280 may include two or more chemical components that are physically separated prior to use by a barrier. Activation of the heat source may thus be achieved by rupture of the physical barrier to permit combination of separate chemical components. In another embodiment, the warming pack 280 may include an exothermic solid composition e.g., a metal powder, brings about an exothermic reaction in the presence of air or oxygen. The exothermic heat-generating component may include a particulate solid, for example, of granules, pellets or slugs. The exothermic heat-generating component may include iron, carbon, metal salts and / or water. The heat-generating component may be placed within an oxygen permeable containment or enclosure. The containment may be segmented into small pockets to keep the heat-generating component evenly distributed throughout the containment. Alternately, the heat-generating component may be free flowing within the containment. The permeable layer may include, for example, a non-woven material or alternately a microporous fdm. The permeable layer may include one or more of the surfaces of the containment.

[0147] The warming pack 280 may further include at least one securement portion 286, 288 configured to secure the warming pack 280 around the pre-filled syringe 200. For example, the securement portions 286, 288 may include a first securement portion 286 of a first fastener and a second securement portion 288 of a second fastener. One of the first and second fasteners may include a plurality of hook structures and another of the first and second fasteners may include a plurality of loop structures to be releasably secure the warming pack 280 in a hook and loop attachment, such as a Velcro attachment. However, in alternative embodiments, the at least one securement portion 286, 288 may include other mechanical attachments (e.g., a clip or snaps), magnetic fasteners, and / or a releasable adhesive. The warming pack may be a substantially planar flexible component configured for wrapping around the pre-filled syringe.

[0148] In some aspects, following activation of the warming pack 280, the outer surface of the warming pack 280 (e.g., the outer pouch 282) may reach a maximum temperature of 30-50° C, optionally 30-41° C, optionally 40-50° C such as, for example, 30° C, 30.5° C, 31° C, 31.5° C, 32° C, 32.5° C, 33° C, 33.5° C, 34° C, 34.5 ° C, 35° C, 35.5° C, 36° C, 36.5° C, 37° C, 37.5° C, 38° C, 38.5° C, 39° C, 39.5° C, 40° C, 40.5° C, 41° C, 41.5° C, 42° C, 42.5° C, 43° C, 43.5° C, 44° C, 44.5 ° C, 45° C, 45.5° C, 46° C, 46.5° C, 47° C, 47.5° C, 48° C, 48.5° C, 49° C, 49.5° C, or 50° C.In an embodiment, after activation with the warming pack 280 at a temperature of 20 °C, the outer surface of the warming pack 280 may reach the aforementioned maximum temperatures when the warming pack 280 is maintained in a room temperature environment of 20° C. In another embodiment, after activation with the warming pack 280 at a temperature of 5 °C, the outer surface of the warming pack 280 may reach the aforementioned temperatures when the warming pack 280 is maintained in a room temperature environment of 20° C.

[0149] In some aspects, following activation of the warming pack 280, the outer pouch 282 of the warming pack 280 may reach a maximum temperature of about 30-50° C, optionally about 30- 41° C, optionally about 40-50° C such as, for example, about 30° C, about 30.5° C, about 31° C, about 31.5° C, about 32° C, about 32.5° C, about 33° C, about 33.5° C, about 34° C, about 34.5 ° C, about 35° C, about 35.5° C, about 36° C, about 36.5° C, about 37° C, about 37.5° C, about 38° C, about 38.5° C, about 39° C, about 39.5° C, about 40° C, about 40.5° C, about 41° C, about 41.5° C, about 42° C, about 42.5° C, about 43° C, about 43.5° C, about 44° C, about 44.5 ° C, about 45° C, about 45.5° C, about 46° C, about 46.5° C, about 47° C, about 47.5° C, about 48° C, about 48.5° C, about 49° C, about 49.5° C, or about 50° C.

[0150] In an embodiment, the kit according to the present disclosure may include one warming pack 280. In other embodiments, the kit may include more than one warming pack (e.g. , two, three, or more) warming packs 280.

[0151] It has been found that the use of a warming pack 280 to expedite defrosting of the diluent 201 contained in pre-filled syringe 200 does not have adverse effects on the physical or chemical stability of the diluent. Table 1 below shows quality data for different examples of syringes 200 containing a diluent 201 according to the present disclosure, after defrosting from a substantially solid state.

[0152] Syringe types A and B each contained a diluent that included 73 wt% - 77 wt% of an organic solvent in the form of dimethyl sulfoxide (DMSO) and 23 wt% - 27 wt% of a biodegradable polymer excipient. The syringe types A and B differed only by the amount of the diluent they contained: syringe type A was filled with approximately 1.24 g of the diluent, and syringe type B was filled with approximately 1.74 g of the diluent 201. Multiple samples of each syringe type containing the diluent were stored in a refrigerated environment of 2 °C 8 °C with the diluent in a solid state. The syringes were then removed from the refrigerated environment and kept at room temperature for 2 hours. The diluent in the syringes was transitioned from the solid state to a liquid state to facilitate subsequent transfer of the diluent for reconstituting a medicament. Two alternative warming methods were used to transition the diluent from a solid to liquid state: in a first method, a first group of syringe types A and B were held in the room temperature environment for 2 hours to melt the diluent, whereas in a second method for each of a second group of syringe types A and B, a warming pack was wrapped around each of the syringes for 30 minutes to accelerate the melting of the diluent. The warming pack was at room temperature whenactivated, and the maximum temperature developed at an outer surface of the warming pack was 42 °C. With respect to the data in Table 1, appearance was assessed visually. Number average molecular weight (Mn) was assessed using gel permeation chromatography (GPC). Molecular weights are expressed in Daltons (Da), also known as atomic mass units (amu). Viscosity was measured using rotational rheometry at a shear rate of 100 s1and temperature of 15 °C to 25 °C. As the diluent is a Newtonian fluid, its viscosity remains constant with differing shear rates. Volume was determined by weight measurement of the sample and by dividing the weight by the sample density, where sample density was determined using a pycnometer.Warming Using a Warming Pack

[0153] The quality data in Table 1 indicates that the warming method used for transitioning the diluent from the solid state to the liquid state had no effect on the appearance of the diluent in the liquid state. According to visual inspection, the diluent remained clear, colorless and viscous whether or not a warming pack was used to accelerate the process. There was also no difference in the viscosity of the diluent, as measured by rotational rheometry, and no measurable difference in the number average molecular weight of the diluent, regardless of whether or not a warming pack was used to accelerate the diluent melting process.

[0154] Additionally, it was found that the storage of the pre-fdled syringe 200 in a refrigerated environment, and also the method used for subsequently melting the diluent 201 in the pre-fdled syringe 200, has an effect on the initiation force needed to transfer the melted diluent 201 from the pre-fdled syringe. The initiation force is the force required at the syringe plunger rod to initiate transfer of the diluent 201 from the pre-fdled syringe 200. Without wishing to be bound by theory,it is believed that this effect arises partially from unavoidable variations in physical features of components of the pre-fdled syringe 200 resulting from manufacture (e.g., within tolerances). For example, different production batches of the syringe body 202, plunger rod 204, and / or the stopper 206 can include small variations in physical features (dimensions, coating, etc.). The effect of these variations on the functional performance of the pre-fdled syringe 200 can then be exacerbated by storing the pre-fdled syringe in a refrigerated environment (e.g., at or below 8°C or between 2°C and 8°C) and subsequently warming the pre-fdled syringe 200 for transfer of the diluent 201, possibly owing to thermal expansion and contraction of the pre-fdled syringe components and its contents.

[0155] Additionally, it is believed that this effect arises partially from pockets of diluent 201, particularly in the vicinity of the stopper 208, remaining relatively chilled or even frozen for extended periods of time after the majority of the diluent 201 appears defrosted. This can cause the effective viscosity of the diluent 201 in the vicinity of the stopper 208 to be elevated relative to diluent 201 located elsewhere within the pre-filled syringe 200, thus leading to the requirement of an elevated initiation force to begin diluent transfer. Use of a warming pack to expedite heating can reduce or eliminate the risk of diluent pockets remaining fully or partially frozen.

[0156] FIG. 49 illustrates initiation forces for pre-filled syringes measured after using different methods for warming the syringes. In particular, initiation forces are illustrated for pre-filled syringes in which the diluent was melted solely by a prolonged period (3 hours) at room temperature and for pre-filled syringes in which the diluent was melted using warming packs. As shown in FIG. 49, warming the pre-filled syringe after refrigeration using a warming pack as opposed to solely by a prolonged period at room temperature reduces the subsequent initiation force of the syringe.

[0157] The pre-filled syringes to which FIG. 49 relates were filled with 1.24 g of a diluent including an organic solvent in the form of dimethyl sulfoxide (DMSO) and a biodegradable polymer excipient according to an embodiment of the present disclosure and were stored in a refrigerated environment (i.e. , between 2°C and 8°C) with the diluent in a solid state. The prefilled syringes were then removed from the refrigerated environment and different samples were (i) defrosted at room temperature for 3 hours; (ii) defrosted using Warming Pack A activated from a refrigerated state (to reflect storing with the pre-filled syringe 201 in the refrigerated environment) for 15 minutes; (iii) defrosted using Warming Pack B activated from a refrigerated state for 15 minutes; (iv) defrosted using Warming Pack A activated from room temperature i.e., between 20°C and 25°C) for 15 minutes; and (v) using Warming Pack B activated from room temperature for 15 minutes.

[0158] For each warming method, 30 pre-filled syringes were tested. Warming Pack A was configured to reach a lower outer surface maximum temperature than Warming Pack B, both when activated form a refrigerated state and from room temperature. In particular, the outer surface ofWarming Pack A was configured to reach a maximum temperature of 37-41 °C when activated from room temperature and 30-32 °C when activated from a refrigerated state, whereas Warming Pack B was configured to reach a maximum temperature of 43-46.5 °C when activated from room temperature and 40-41 °C when activated from a refrigerated state.

[0159] The data shown in FIG. 49 was obtained by using a motorized test stand to move the plunger rod of each pre-filled syringe at a constant speed of 100 mm / min and recording the initiation force required to move the stopper within the barrel of the pre-filled syringe. For prefilled syringes warmed solely in a room temperature environment, without utilizing a warming pack, the measured initiation forces varied from about 10 N to over 70 N, with the interquartile range extending from about 14 N to about 51 N. In contrast, for pre-filled syringes warmed using either of the warming packs, the measured initiation forces were lower overall, regardless of the temperature at which the warming packs were activated. In particular, use of the warming packs significantly narrowed and lowered the interquartile range of the measured initiation forces. For pre-filled syringes warmed using Warming Pack A activated from a refrigerated state, initiation forces ranged from about 5N to 66N, with the interquartile range extending from about 16N to 35N. For pre-filled syringes warmed using Warming Pack B activated from a refrigerated state, initiation forces ranged from about 5N to 34N, with the interquartile range extending from about 7N to 18N. For pre-filled syringes warmed using Warming Pack A activated from room temperature, initiation forces ranged from about 6N to 40N, with the interquartile range extending from about 10N to 39N. For pre-filled syringes warmed using Warming Pack B activated from room temperature initiation forces ranged from about 4N to 36N, with the interquartile range extending from about 7N to 10N.

[0160] FIG. 11 illustrates an alternative embodiment of the medicament delivery system including the pre-filled syringe 200, first and second transfer needles 220’, 220”, the vial 230, the dosing syringe 260, and the dosing needle 270. Thus, the medicament delivery system of this embodiment may include three needles 220’, 220”, 270. The delivery system of FIG. 11 may be similar to the delivery system of FIG. 5, except replacing the vial adapter 240 with the second transfer needle 220”. The first transfer needle 220’ may be attachable to the pre-filled syringe 200 to introduce the diluent 201 into the vial 230 through the septum 238. The second transfer needle 220” may be attachable to the dosing syringe 260 to remove the reconstituted medicament from the vial 230 through the septum 238, as discussed herein. The first transfer needle 220’ may have a smaller diameter than the second transfer needle 220” to reduce particulate generation during the initial puncturing of the septum 238 and to prevent generating holes in the septum 238 that cannot reseal upon removal of the first transfer needle 220’. The resealing of the septum 238 allows for storage of the reconstituted medicament for up to 24 hours, as discussed herein. The second transfer needle 220” may be larger than the first transfer needle 220’ because the septum 238 does not need to be resealed after transfer of the reconstituted medicament from the vial 230 to thedosing syringe 260. The larger diameter of the second transfer needle 220” may accommodate the more viscous solution after reconstitution. For example, the first transfer needle 220’ may be 21 gauge, and the second transfer needle 220” may be 19 gauge. Alternatively, the first and second transfer needles 220’, 220” may have same diameters. For example, the first transfer needle 220’ and the second transfer needle 220” may be 21 gauge. Additionally, the dosing needle 270 may have the same diameter as the first and second transfer needles 220’,such as 21 gauge. In some embodiments, the first and / or second transfer needles 220’, 200” may have the same structure as the transfer needle 220 (as illustrated in and discussed with reference to FIG. 5). In some embodiments (as illustrated in FIG. 11), the first and / or second transfer needles 220’, 200” may have the same structure as the dosing needle 270 (as illustrated in and discussed with reference to FIG. 5). Therefore, in some embodiments, the first transfer needle 220’, the second transfer needle and the dosing needle 270 may be identical.

[0161] Thus, each embodiment of the kit as disclosed herein may include a medicament delivery system having a transfer needle 220 (or 220’) and a vial adapter 240 as illustrated in FIG. 5, a vial adapter 240’ without a transfer needle as illustrated in FIG. 6, or two transfer needles 220’, 220” without a vial adapter as illustrated in FIG. 11. The constant components of the embodiments of the kit may include the pre-filled syringe 200, the vial 230, the dosing syringe 260, and the dosing needle 270.

[0162] FIG. 12 illustrates a method 1000 for preparing and / or administering the medicament. Step 1002 may include receiving the kit 100, 300, 400, 500, 500’, 600, 700, 800, 900, 1100 including the container 102 enclosing the medicament delivery system and the warming pack 280. The kit 100, 300, 400, 500, 500’, 600, 700, 800, 900, 1100 may be stored in a refrigerated state (e.g., at or below 8°C or between 2°C and 8°C), where the medicament is olanzapine or a pharmaceutically acceptable salt thereof in a yellow powder, and the diluent 201 is in a frozen, opaque solid state. The kit 100 may configured as any embodiment as discussed herein, and the components of the medicament delivery system may have a layout and be unpackaged, as further discussed herein.

[0163] Step 1004 may include warming the diluent 201 in the pre-filled syringe 200 and / or the medicament in the vial 230 with the warming pack 280. As such, step 1004 may include removing the kit 100 from the refrigerated state. Warming the diluent 201 in the pre-filled syringe may include warming the diluent 201 from at or below 8°C (e.g., 2°C and 8°C) up to at least a melting point of about 12°C to 18°C, in order to defrost the diluent 201 from the solid state into a liquid state. For example, the defrosting may be warming the diluent 201 to room temperature (20°C to 25 °C). Warming the diluent 201 may be stopped when the diluent 201 is defrosted, when the diluent 201 reaches at room temperature, or when the diluent 201 reaches a temperature slightly above room temperature (e.g. at about 30°C). Thus, warming the diluent 201 may be to a temperature below body temperature (37°C), and the diluent 201 may remain below bodytemperature prior to administration. In some embodiments, warming the diluent 201 may be to body temperature (37°C).

[0164] Prior to step 1004, the kit 100 may be conditioned at room temperature for a conditioning period of time prior to activating the warming pack 280. Conditioning the pre-fdled syringe 200 and the warming pack 280 for a conditioning period of time at room temperature prior to activating the warming pack 280 may allow the warming pack 280 and the pre-fdled syringe 200 to warm initially from the refrigerated state. In particular, allowing the warming pack 280 to warm to an extent from the refrigerated state and prior to activation can increase the maximum temperature achieved by the warming pack 280 following activation. In an embodiment, the conditioning period of time can be up to 45 minutes, up to 30 minutes, or up to 15 minutes, and the conditioning period of time can be at least 5 minutes or at least 10 minutes. Optionally, the conditioning period of time can be 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes, or 45 minutes. The pre-fdled syringe 200 and the warming pack 280 may be conditioned within a container of any of the kits of the present disclosure (i.e. , prior to opening the kit). In another embodiment, the pre-fdled syringe 200 and the warming pack 280 can be removed from the kit upon removal of the kit from the refrigerated state, such that the prefdled syringe 200 and the warming pack 280 are conditioned external to the kit.

[0165] Additionally, prior to or during step 1004, the warming pack 280 may be activated in order to initiate heating of the warming pack. In an embodiment, the warming pack 280 may be activated by manipulating the activator 284 to generate an exothermic reaction. In some embodiments, the activator 284 is to release a small number of crystals of sodium acetate which act as nucleation sites for the crystallization of the sodium acetate into a hydrated salt in an exothermic reaction. In some embodiments, the warming pack 280 may be secured with the at least one securement portion 286, 288 around the pre-fdled syringe 200 and / or vial 230 to ensure uniform heat transfer and / or facilitate handling. For example, warming the diluent 201 may include placing the diluent 201 in a center of the warming pack 280, and wrapping the warming pack 280 around the pre-fdled syringe 200 with the ends of the warming pack 280 placed over each other to be secured with the securement portions 286, 288 (e.g., a hook and loop fastener). The warming pack 280 may be activated with the warming pack being at a temperature of 5°C. In such an embodiment, the warming pack is activated immediately after being removed from a refrigerated state. In an embodiment, the warming pack may be activated with the warming pack being at a temperature of from 5°C to 15°C. In such an embodiment, the warming pack may be conditioned for a period of time at room temperature after being removed from the refrigerated state. In an embodiment, the warming pack may be activated with the warming pack being at a temperature of 20°C. In such an embodiment, the warming pack is activated after storage at room temperature, or conditioning at room temperature for a sufficient period of time to allow the warming pack to reach room temperature.

[0166] In an embodiment, defrosting the diluent 201 with the warming pack 280 may take up to 30 minutes. In another embodiment, defrosting the diluent 201 with the warming pack 280 may take up to 15 minutes. In a particular embodiment, defrosting the diluent 201 with the warming pack 280 may take about 10-15 minutes. In a particular embodiment, defrosting the diluent 201 with the warming pack 280 can take about 15 minutes. Alternatively, the diluent 201 may be defrosted to room temperature (20°C to 25°C) without the warming pack 280 for up to about 3 hours. In other embodiments, the diluent 201 may be defrosted to room temperature without the warming pack 280 for up to about 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, or 12 hours. The medicament may also be loosened by inverting the vial 230 and tapping the vial 230 gently on a table. In some embodiments, the vial 230 may be individually packaged in a box for protection during tapping.

[0167] Step 1006 may include introducing the diluent 201 into the vial 230 to reconstitute the medicament. In some embodiments, step 1006 may include attaching the transfer needle 220 (or 220’) to the pre-fdled syringe 200. The cap 206 may be initially removed from the pre-fdled syringe 200, and the attachment of the transfer needle 220 to the pre-fdled syringe 200 may be with a Luer connection. A cap may be initially removed from the vial 230, and the septum 238 of the vial 230 may be sterilized, such as with an alcohol wipe. The diluent 201 may be introduced by puncturing the septum 238 with the transfer needle 220 and depressing the plunger rod 204 to push the diluent 201 into the vial 230. The septum 238 may reseal the vial 230 after removal of the transfer needle 220 due to the size of the transfer needle 220. In some embodiments, the vial adapter 240’ may be attached to the vial 230 and the pre-filled syringe 200 may be attached to the vial adapter 240’. The vial adapter 240 may be attached to the vial 230 by peeling back the backing of the blister package to expose a bottom opening of the skirt 250 while holding the vial adapter 240 at the plastic shell of the blister packaging. The skirt 250 of the vial adapter 240 may be then pressed onto the vial 230 to puncture the septum 238 with the cannula 252 of the vial adapter 240. The plastic shell may then be removed from the vial adapter 240, with the vial adapter 240 attached to the vial 230 in a sterile condition. The diluent 201 may be introduced into the vial 230 through the vial adapter 240’ by depressing the plunger rod 204 to push the diluent 201 into the vial 230 to deform the valve 246’. The valve 246’ may seal the vial adapter 240’ after the syringe 200 is removed.

[0168] After introducing the diluent 201, the method 1000 may include a step of equalizing pressure in the vial 230 by pulling back on the plunger rod 204 about 1 to 2 centimeters to draw air into the pre-filled syringe 200 without drawing diluent 201. The method 1000 may further include fully depressing the plunger again to reintroduce the air into the vial 230, and pulling back on the plunger rod 204 about 1 to 2 centimeters a second time to withdraw air into the pre-filled syringe 200 without drawing diluent 201. The vial 230 may be unvented to prevent the diluent 201 from escaping the vial 230.

[0169] Step 1008 may include reconstituting the medicament. The reconstitution of the medicament may be performed by placing a soft surface (e.g., a soft pad on a table) and tapping the vial 230 on the soft surface until no dry powder remains. For example, this tapping step may take approximately 2 minutes. After the tapping, the user may visually check the vial 230 for any dry powder. If dry powder remains, the user may continue to tap the vial 230. Once all of the dry powder is suspended in the diluent 201, the user may vigorously shake the vial 230 for 30 seconds to further mix the medicament into the diluent. After mixing, the reconstituted medicament should be an opaque yellow suspension. In some embodiments, the user may compare the color of the reconstituted medicament to a swatch on the 596 on the kit 100 to ensure that the medicament has been properly reconstituted.

[0170] In some aspects, the disclosure provides pharmaceutical compositions for administration by subcutaneous injection wherein the compositions comprise 20%-45% (w / w) of olanzapine; 35% - 65% (w / w) of an organic solvent comprising dimethyl sulfoxide (DMSO), N-methyl-2- pyrrolidinone (NMP), or a mixture thereof; and 10% -25% by weight (w / w) the composition of diblock copolymer and triblock copolymer together.

[0171] In some aspects, the compositions of the disclosure comprise 20%-45%, optionally 22%- 34%, optionally 30%-32%, by weight (w / w) of olanzapine, such as, for example, 20.0%, 20.5%, 21.0%, 21.5%, 22.0%, 22.5%, 23.0%, 23.5%, 24.0%, 24.5%, 25.0%, 25.5%, 26.0%, 26.5%, 27.0%,27.5%, 28.0%, 28.5%, 29.0%, 29.5%, 30.0%, 30.5%, 31.0%, 31.5%, 32.0%, 32.5%, 33.0%, 33.5%.34.0%, 34.5%, 35.0%, 35.5%, 36.0%, 36.5%, 37.0%, 37.5%, 38.0%, 38.5%, 39.0%, 39.5% 40.0%.41.0%, 41.5%, 42.0%, 42.5%, 43.0%, 43.5%, 44.0%, 44.5%, or 45.0% by weight (w / w) of olanzapine.

[0172] In some aspects, the compositions of the disclosure (i.e. the reconstituted medicament) comprise about 20%- about 45% by weight (w / w) of olanzapine, such as, for example, about 20%, about 21%, about 22%, about 23%, about 24%, about 25%, about 26%, about 27%, about 28%, about 29%, about 30%, about 31%, about 32%, about 33%, about 34%, about 35%, about 36%, about 37%, about 38%, about 39%, about 40%, about 41.0%, about 41.5%, about 42.0%, about42.5%, about 43.0%, about 43.5%, about 44.0%, about 44.5%, or about 45.0% by weight (w / w) of olanzapine. In some embodiments, the compositions of the disclosure comprise 22%-34% by weight (w / w) olanzapine, such as, for example, 22.0%, 22.5%, 23%, 23.5%, 24.0%, 24.5%, 25.0%,25.5%, 26.0%, 26.5%, 27.0%, 27.5%, 28.0%, 28.5%, 29.0%, 29.5%, 30.0%, 30.5%, 31.0%, 31.5%.32.0%, 32.5%, 33.0%, 33.5% or 34.0% by weight (w / w) of olanzapine.

[0173] In some aspects, the compositions of the disclosure (i.e., the reconstituted medicament) comprise 35%-65%, optionally 50%-55%, by weight (w / w) of the organic solvent, such as, for example, 35.0%, 35.5%, 36.0%, 36.5%, 37.0%, 37.5%, 38.0%, 38.5%, 39.0%, 39.5%, 40.0%.40.5%, 41.0%, 41.5%, 42.0%, 42.5%, 43.0%, 43.5%, 44.0%, 44.5%, 45.0%, 45.5%, 46.0%, 46.5%,47.0%, 47.5%, 48.0%, 48.5%, 49.0%, 49.5%, 50.0%, 50.5%, 51.0%, 51.5%, 52.0%, 52.5%, 53.0%,53.5%, 54.0%, 54.5%, 55.0%, 55.5%, 56.0%, 56.5%, 57.0%, 57.5%, 58.0%, 58.5%, 59.0%, 59.5%, 60.0%, 60.5%, 61.0%, 61.5%, 62.0%, 62.5%, 63.0%, 63.5%, 64.0%, 64.5%, or 65.0% by weight (w / w) of an organic solvent.

[0174] In some aspects, the compositions of the disclosure comprise about 35% to about 65% by weight (w / w) of the organic solvent, such as, for example, about 35%, about 36%, about 37%, about 38%, about 39%, about 40%, about 41%, about 42%, about 43%, about 44%, about 45%, about 46%, about 47%, about 48%, about 49%, about 50%, about 51%, about 52%, about 53%, about 54%, about 55%, about 56%, about 57%, about 58%, about 59%, about 60%, about 61%, about 62%, about 63%, about 64%, or about 65% by weight (w / w) of an organic solvent.

[0175] In some aspects, the compositions of the disclosure (i.e., the reconstituted medicament) comprise 15%- 17.5% by weight (w / w) of the biodegradable polymer excipient.

[0176] Step 1010 may include optionally storing the vial 230 containing the reconstituted medicament at room temperature (20°C to 25°C) for up to 24 hours. The vial 230 containing the reconstituted medicament may be stored at room temperature (20 °C to 25 °C) for up to 24 hours, with excursions permitted at 15 °C to 30 °C. During storing, the self-sealing nature of the vial 230 septum 238 and / or the valve 246’ of the vial adapter 240’ may prevent contaminants from entering the vial 230. For example, the vial 230 containing the reconstituted medicament may be stored for at least 15 minutes in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for at least 5 minutes in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for at least 30 minutes in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for at least 1 hour in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for at least 2 hours in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for at least 3 hours in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for at least 6 hours in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for at least 12 hours in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for at least 18 hours in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for at least 20 hours in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for up to 30 minutes in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for up to 1 hour in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for up to 2 hours in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for up to 3 hours in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for up to 6 hours in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for up to 12 hours in a room temperatureenvironment. The vial 230 containing the reconstituted medicament may be stored for up to 18 hours in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored for up to 20 hours in a room temperature environment. The vial 230 containing the reconstituted medicament may be stored anywhere at room temperature including on a counter and / or in a cabinet. Additionally or alternatively, the vial 230 containing the reconstituted medicament may be stored such that the reconstituted medicament is maintained in the form of a liquid suspension. If not used immediately after reconstitution, the user may shake the vial 230 vigorously for 30 seconds before being transferred.

[0177] In embodiments, the diluent 201 may comprises an organic solvent in the form of dimethyl sulfoxide (DMSO), which may increase the shelflife of the medicament after reconstitution, thus facilitating administration. In particular, moderate concentrations of dimethyl sulfoxide (DMSO) have been found to inhibit microbial activity of the reconstituted medicament. For example, when the organic solvent is present in the reconstituted medicament in an amount of from 30 wt% to 70 wt%, with respect to the total weight of the reconstituted medicament, the shelf life of the reconstituted medicament may be extended. Extension of the shelf life in this way can be advantageous for medicaments that need to be prepared prior to arrival of the patient, since waste resulting from late or missed scheduled appointments can be avoided. This may be particularly advantageous when treating patients with psychiatric disorders, such as schizophrenia. In such cases, initiating preparation of the medicament upon arrival of the patient can lead to wait times that may not be suitable for patients with such psychiatric disorders.

[0178] The shelflife of the reconstituted medicament may be extended to 24 hours, for example when an organic solvent in the form of dimethyl sulfoxide (DMSO) is present in the reconstituted medicament in an amount of from 30 wt% to 70 wt%, with respect to the total weight of the reconstituted medicament. In embodiments, the organic solvent may be present in the reconstituted medicament in an amount of from 35 wt% to 65 wt%, or from 40 wt% to 65 wt%, or from 45 wt% to 65 wt%, or from 50 wt% to 60 wt%, or from 52 wt% to 54 wt%, with respect to the total weight of the reconstituted medicament. In embodiments, the diluent and medicament may be present in the reconstituted medicament in the vial in a weight ratio of from 2.0 to 2.5, or from 2. 1 to 2.4. The diluent and medicament may be present in the reconstituted medicament in the vial in a weight ratio of 2.0, or 2.1, or 2.2 or 2.3 or 2.4, or 2.5.

[0179] Table 2 below sets out the results of a microbial growth promotion study carried out on different examples of reconstituted medicaments according to the present disclosure. Each example of the reconstituted medicament was composed of an organic solvent in the form of dimethyl sulfoxide (DMSO), a biodegradable polymer excipient and olanzapine. The dimethyl sulfoxide (DMSO) was present in the reconstituted medicament in an amount of 52 wt% - 54 wt%, with respect to the total weight of the reconstituted medicament. In particular, the composition of the reconstituted medicament comprised 30 wt% - 32 wt% olanzapine, 52 wt% - 54 wt% DMSO,and 15 wt% - 17.5 wt% biodegradable polymer excipient. The examples differed from each other in that Example 1 comprised about 0.9 m of the reconstituted medicament, Example 2 comprised about 1.2 mb of the reconstituted medicament, and Example 3 comprised about 1.5 mb of the reconstituted medicament. Example 4 was a control sample that omitted the biodegradable polymer excipient to confirm that precipitation of the biodegradable polymer excipient upon contact with an aqueous solution had no effect on the results. As such, Example 4 comprised 61 wt% - 65 wt% DMSO and 35 wt% - 39 wt % olanzapine.

[0180] The examples were inoculated with microorganisms according to US Pharmacopeia (USP) chapter 51 (Staphylococcus aureus ATCC 6538, Pseudomonas aeruginosa ATCC 9027, Escherichia coli ATCC 8739, Candida albicans ATCC 10231, Aspergillus brasiliensis ATCC 16404) and one in house microorganism representative of typical skin microflora (Micrococcus luteus). Counts of surviving microorganisms were visually determined immediately after inoculation, after storing at room temperature (15 °C to 25 °C) for 24 hours, and after storing at room temperature for 48 hours. Measurements are shown in colony-forming units (CFU) per milliliter (mL).Table 2: Results of Microbial Growth Promotion Study

[0181] The data in Table 2 demonstrates that the reconstituted medicament according to the present disclosure does not support microbial growth due to adventitious contamination and that the medicament can be stored after reconstitution for at least 24 hours at room temperature (15 °C to 25 °C). Additionally, the reconstituted medicament is strongly bactericidal, fungicidal and yeasticidal.

[0182] In addition to its antimicrobial properties, the reconstituted medicament according to the present disclosure may remain shelf-stable for at least 24 hours at room temperature (15 °C to 25 °C). Table 3 below sets out the results of stability testing of an example reconstituted medicament according to an embodiment of the present disclosure. In particular, the composition of the example reconstituted medicament of Table 3 comprised 30 wt% - 32 wt% olanzapine, 52 wt% - 54 wt% DMSO, and 15 wt% - 17.5 wt% biodegradable polymer excipient.

[0183] The example reconstituted under the stability study was reconstituted in a 10 mb glass vial and stored at a room temperature environment of 15 °C to 25 °C for 24 hours. Various aspects of the reconstituted medicament were tested upon immediately after reconstitution and at a time 24 hours following reconstitution. Appearance was tested visually. Viscosity was tested using rotational rheometry at a shear rate of 100 s1and temperature of 15 °C to 25 °C. As the reconstituted medicament is a non-Newtonian shear thinning fluid, its viscosity decreases with increased shear rates. The proportion of olanzapine in comparison to the intended dosage (Assay Olanzapine) and total impurities were tested using ultra performance liquid chromatography (UPLC). Impurities tested were based on United Stated Pharmacopeia (USP) monographs forOlanzapine. Number average molecular weight (Mn) was tested using gel permeation chromatography (GPC) and molecular weight is expressed in Daltons (Da).

[0184] As shown by the data in Table 3, the stability of the example reconstituted medicament was maintained during storage at room temperature for 24 hours. In particular, the property values depicted in Table 3 illustrate the continued chemical and physical stability of the example reconstituted medicament after storage for 24 hours at room temperature.

[0185] Step 1012 may include transferring a dose of the reconstituted medicament from the vial 230 to the dosing syringe 260. In some embodiments, step 1010 may be performed by attaching the vial adapter 240 to the vial 230 (if the vial adapter 240 is not already attached to the vial 230) and attaching the dosing syringe 260 to the vial adapter 240. In some embodiments, step 1012 may be performed by attaching the second transfer needle 220” to the dosing syringe 260 to puncture the septum 238 of the vial 230. Once the dosing syringe 260 is attached to the vial 230, either via the vial adapter 240 or the transfer needlethe dosing syringe 260 can be filled with the reconstituted medicament by first inverting the dosing syringe 260 and the vial 230. If using the transfer needlethe user must ensure that the tip of the transfer needle 220” is below the level of the reconstituted medicament. Reconstituted medicament can then be drawn into the dosing syringe 260 by pulling the plunger rod 204 until the dosing syringe 260 contains the desired dose. This step can also include repeatedly pulling and depressing the plunger rod 204 to remove air bubbles from the reconstituted medicament.

[0186] After removing the transfer needle 220’ ’ from the dosing syringe 260 or detaching the dosing syringe 260 form the vial adapter 240, step 1014 may include administering the dose of the reconstituted medicament from the dosing syringe 260 to the patient. The administering may be performed by attaching the dosing needle 270 to the dosing syringe 260 and removing the removing the needle shield 276. The medicament may then be administered with the hollow needle 274 to the subject parenterally, for example intramuscularly or subcutaneously, particularlysubcutaneously. The medicament may be injected in a site at an abdomen or upper arm. After removal of the hollow needle 274 from the subject, the safety shield 278 may then be extended over the hollow needle 274. Extending the safety shield 278 may include placing the safety shield 278 on a flat surface and pulling the dosing syringe 260 backward until the safety shield 278 is extended to cover the hollow needle 274. Alternatively, extending the safety shield 278 may include pressing the safety shield 278 with a thumb or finger forward until the safety shield 278 is extended to cover the hollow needle 274. The safety shield 278 may generate an audible click when locked in the extended configuration. The dosing syringe 260 and the dosing needle 270 may then be safely disposed of in a sharps container

[0187] The method 1000 may be performed to treat a subject suffering from a neuropsychiatric disease or otherwise in need of the treatment, comprising administering to the subject the olanzapine or the pharmaceutical composition disclosed herein, wherein the olanzapine or the pharmaceutical composition provides a therapeutically effective plasma concentration of olanzapine for a period of at least about 14 days or at least 21 days or for about 14 days, about 21 days, about 28 days, about 30 days, about 42 days or about 56 days following administration to a patient. In some embodiments, the neuropsychiatric disease is schizophrenia or bipolar disorder.

[0188] Further discussion of pharmaceutical compositions, methods of preparation, and / or methods of treatment are further provided in WO2023 / 139531A1 and / or US2024 / 0238308A1, as expressly incorporated herein by reference.

[0189] FIGS. 13-18 illustrate a second embodiment of a kit 300. Similar to the first embodiment of FIGS. 1-4, the kit 100 may include a container 302, a tray 330, an insert 350, and the medicament delivery assembly. The tray 330 and the insert 350 may be packaged in the container 302. The tray 330 may have a plurality of compartments containing the components of the medicament delivery system. The tray 330 may include a first compartment 332 containing the pre-filled syringe 200, a second compartment 334 containing the transfer needle 220 (or 220’), and a third compartment 336 containing the vial 230. The tray 330 may further include a fourth compartment 338 containing the vial adapter 240 (or 240’), a fifth compartment 340 containing the dosing syringe 260, and a sixth compartment 342 containing the dosing needle 270. The kit 300 may provide a clear, intuitive layout of the medicament delivery system to ensure that the user has a clear understanding of the medicament and to provide a clear navigation through the administration of olanzapine, as discussed above with respect to the first embodiment, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0190] As further illustrated, the insert 350 may include a first partition 360 overlaying a first enclosure of the tray 330 including the first, second, and third compartments 332-336 (containing the first group of the components) and a second partition 362 overlaying a second enclosure of the tray 330 including the fourth, fifth, and sixth compartments 338-342 (containing the second group of the components). The first enclosure of the tray 330 may also receive the warming pack 280overlying one or more of the first, second, and third compartments 332-336. The first and second partitions 360, 362 may include one or more indicia providing information to the user. The first partition 360 may include a first indicia, and the second partition 362 may include a second indicia, where at least part of the first indicia and the second indicia are different. For example, the first indicia may readily identify the first group of components and their intended use of preparing the medicament. The second indicia may readily identify the second group of components and their intended use of dosing the medicament. The indicia may include distinct colors, lines, letters, numbers, patterns, ribs, and / or grooves, as discussed with respect to the first embodiment, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0191] The first partition 360 may be attached to the remainder of the insert 350 at a first portion 361 that is weakened or perforated and extending at least partially around the first partition 360 in a first, closed configuration. The first partition 360 may also be attached to the insert 350 at a second portion. The second portion may form a pivot as the first partition 360 is opened to expose the first, second, and third compartments of the tray 330 in a second, open configuration, as illustrated in FIGS. 14 and 15. Thus, in the open configuration, the first partition 360 may enable removal of the pre-filled syringe 200, the transfer needle 220, the vial 230, and / or the warming pack 280 for preparing the medicament. A first side of the first partition 360 visible when in the closed configuration may provide a surface for the first indicia providing information on the first stage of preparing the medicament. For example, the first side of the first partition 360 may display information identifying the preparation step and / or identifying the first group of components. A second side of the first partition 360 visible in the open configuration may provide a surface for third indicia providing information on the first stage of preparing the medicament. The second side of the first partition 360 may display instructions for reconstituting the medicament and / or one or more checkboxes for each step of the reconstitution to induce an affirmative action of a checklist for the user to ensure that the steps are correctly followed. For example, the first partition 360 may include instructions on preparation due to the position overlaying the pre-filled syringe 200, the transfer needle 220, the vial 230, and / or the warming pack 280.

[0192] The second partition 362 may be attached to the remainder of the insert 350 at a first portion 363 that is weakened or perforated and extending at least partially around the second partition 362. The second partition 362 may also be attached to the insert 350 at a second portion in a first, closed configuration. The second portion may form a pivot as the second partition 362 is opened or removed from the fourth, fifth, and sixth compartments of the tray 330 into a second, open configuration, as illustrated in FIGS. 16 and 17. Thus, in a second, open configuration, the second partition 362 may enable removal of the vial adapter 240, the dosing syringe 260, and / or the dosing needle 270 for dosing the medicament. A first side of the first partition 360 exposed in the closed configuration may provide a surface for the first indicia providing information on the second stage of preparing the medicament. For example, the first side of the first partition 360 maydisplay information identifying the administration or dosing step and / or identifying the second group of components. The first side of the second partition 362 may, additionally or alternatively, include a warning to prompt the user to open the first partition 360 before the second partition 362. Similar to the first partition 360, a second side of the second partition 362 visible in the open configuration may provide a surface for fourth indicia providing information on the second stage of dosing the medicament. The second partition 362 may include information on the dosing due to the position overlaying the vial adapter 240, the dosing syringe 260, and the dosing needle 270. For example, the second side of the second partition 362 may display instructions for reconstituting the medicament and / or more checkboxes for each step of the reconstitution to induce an affirmative action in a checklist for the user to ensure that the steps are correctly followed.

[0193] For each of the first and second partitions 360, 362, the insert 350 may include a cutout 364 for access of a finger of the user to facilitate lifting of the first and second partitions 360, 362. The first and second partitions 360, 362 may be individually openable. The opening experience of the first and second partitions 360, 362 may reduce visual confusion, in that the components are revealed by a sequence. The first and second partitions 360, 362 may include warnings and check prompts next to the components and / or include a check list used in graphics.

[0194] As further discussed with respect to the first embodiment (as expressly incorporated herein), a further indication of the order of operation may be in the orientation of one or more of the components in the respective compartment. As illustrated in FIG. 17, the vial adapter 240 may at least partially overlay the dosing syringe 260 and / or the dosing needle 270. The overlay of the vial adapter 240 may display the components to the user prior to the dosing syringe 260 and the dosing needle 270, such that the vial adapter 240 is removed from the tray 330 prior to the dosing syringe 260 and the dosing needle 270. The vial adapter 240 may be oriented with the backing of the packaging disposed in a horizontal configuration above the plastic of the packaging, such that the vial adapter 240 extends between the dosing syringe 260 and the needle 270. As discussed with respect to the first embodiment, the individual packaging of the dosing syringe 260 and / or the dosing needle 270 may be placed on its side, such that the backing extends vertically through the respective compartment to reduce visibility while positioned in the tray 130 to the user. Thus, only the side profile of the packaging would be visible to the user upon opening of the container 102 and removing the vial adapter 240. Thus, the packaging may be less visible to the user, making the dosing syringe 260 and / or the dosing needle 270 less prominent in the tray 330. The overlay of the vial adapter 240 may further reduce visibility of the dosing syringe 260 and / or the dosing needle 270 when packaged in the tray 330.

[0195] As further illustrated in FIG. 18, the insert 350 may be a three-dimensional structure, for example in the form of a sleeve. An upper horizontal panel 366 of the insert 350 may be configured to overlay the tray 330 and include the first partition 360 and the second partition 362. The insert 350 may include first and second vertical side panels 367 and / or a lower horizontal panel368. Thus, the insert 350 may be configured to receive the tray 330 by sliding the tray 330 into a side opening of the insert 350 before the tray 330 and the insert 350 are inserted into the container 302.

[0196] FIGS. 19-23 illustrate a third embodiment of a kit 400. Similar to the first and / or second embodiments, the kit 400 may include a container 402, a tray 430, an insert 450, and the medicament delivery system. The tray 430 and the insert 450 may be packaged in the container 402. The tray 430 may have a plurality of compartments containing the components of the medicament delivery system. The tray 430 may include a first compartment 432 containing the pre-filled syringe 200, a second compartment 434 containing the transfer needle 220 (or 220’), and a third compartment 436 containing the vial 230. The tray 430 may further include a fourth compartment 438 containing the vial adapter 240 (or 240’), a fifth compartment 440 containing the dosing syringe 260, and a sixth compartment 442 containing the dosing syringe 260. The kit 400 may provide a clear, intuitive layout of the medicament delivery system to ensure that the user has a clear understanding of the medicament and to provide a clear navigation through the administration of olanzapine, as discussed above with respect to the first and / or second embodiments, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0197] As illustrated, the container 402 may include a central panel 416 having a first configuration covering the tray 430 and / or the insert 450 (as illustrated in FIG. 19) and a second configuration removed from the tray 430 and / or the insert 450 (as illustrated in FIG. 20). The central panel 416 may be pivotably attached to the front panel 404 of the container 401 to be pivoted between the first configuration and the second configuration. The central panel 416 may provide a large fold down panel for a quick reference guide, including a check list. In some embodiments, the central panel 416 may include a first portion 416a and a second portion 416b pivotably attached to each other, where the first portion 416a has a length at least about the same as a length of the front panel 404 such that in the second configuration, the first portion 416a extends vertically along the front panel 404 and the second portion 416b lays flat on a table, as illustrated in FIGS. 20 and 21. The first and / or second portion 416a, 416b may include information on the preparing and / or dosing of the medicament, as discussed in the first and / or second embodiment, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0198] As further illustrated, the insert 450 may include one or more tabs 470 associated with one or more of the compartments 432-442 including information for the respective component 432- 442. For example, the insert 450 may include a tab 470 for each of the compartments 432-442 to include information for the components disposed therein. The tabs 470 may extend laterally from the insert 450 over at least portion of the compartment 432-442 and / or the component inside of the compartment 432-442 to provide visual information in the line of site of the user when viewing the component. Thus, the tabs 470 may, additionally or alternatively, help retain the component in the respective compartment because the tabs extend over the component when positioned in the tray430, for example in a flagged configuration. As illustrated in FIG. 22, the tabs 470 may be configured to deflect or pivot away from the tray 430 when the component is removed from the compartment 432-442. In some embodiments, the tabs 470 may remain deflected after the component is removed to indicate to the user that the respective component was removed from the compartment 432-442. The deflection of the tabs 470 may thus visually indicate a progress of the reconstitution or dosing of the medicament. The tabs 470 of the first group of the compartments may include a first indicia, and the tabs 470 of the second group of the compartments may include a second indicia, where the first indicia and the second indicia are different. For example, the first indicia may readily identify the first group of components and their intended use in preparing the medicament. The second indicia may readily identify the second group of components and their intended use in dosing the medicament. The indicia may include distinct colors, lines, letters, numbers, patterns, ribs, and / or grooves. The indicia of one or more of the name of the component, the order of operation of the component, the grouping of the component, and / or toxicity, as discussed with respect to the first and / or second embodiments, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0199] Thus, the kit 400 may provide an opening experience that reduces confusion by revealing the sequence of the components. The central panel 416 may provide a large fold down panel for a quick reference guide. The kit 400 may further provide key stage gates prompted by a check list.

[0200] FIGS. 24-30 illustrate a fourth embodiment of a kit 500. FIG. 31 illustrates a fifth embodiment of a kit 500’ . Similar to the first, second and / or third embodiments, the kit 500, 500’ may include a container 502, a tray 530, and the medicament delivery assembly. The tray 530 may be packaged in the container 502. The tray 530 may have a plurality of compartments containing the components of the medicament delivery system. The tray 530 may include a first compartment 532 containing the pre-filled syringe 200, a second compartment 534 containing the transfer needle 220 (or 220’), and a third compartment 536 containing the vial 230. The tray 530 may further include a fourth compartment 538 containing the vial adapter 240 (or 240’), a fifth compartment 540 containing the dosing syringe 260, and a sixth compartment 542 containing the dosing syringe 260. The kit 500 may provide a clear, intuitive layout of the medicament delivery system to ensure that the user has a clear understanding of the medicament and to provide a clear navigation through the administration of olanzapine, as discussed above with respect to the first, second, and / or third embodiments, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0201] As illustrated, the kit 500 may include a sheet 590 having a first, folded configuration to be retained in the container 502 and at least one second, unfolded configuration. For example, the sheet 590 may include a plurality of panels 592 joined by a plurality of creases 594 configured to enable the sheet 590 to be folded and unfolded between the first configuration and the second configuration. The creases 594 may extend in a number of directions, including vertically andlaterally producing panels 592 of different sizes and shapes, as illustrated in FIG. 26. In the second configuration, the sheet 590 may provide a large, illustrative quick reference guide with illustrations that visually navigate each step of using the medicament delivery system. The sheet 590 may include a printed and / or textured swatch 596 to allow the user to visually compare to the reconstituted medicament to ensure that the medicament has a proper consistency and / or efficacy. The swatch 596 may illustrate color variations of the reconstituted medicament to indicate the grades for various optimal and / or suboptimal consistencies. For example, the swatch 596 may include one or more bands of color visually indicating a consistency of the reconstituted medicament that is graded to be very good, good, fair, lightly dehydrated, dehydrated, very dehydrated, and / or severely dehydrated.

[0202] Similar to the third embodiment, the kit 500 may further include tabs 570 associated with one or more of the components. The tabs 570 may have indicia of one or more of the name of the component, the order of operation of the component, the grouping of the component, and / or toxicity. The indicia on the tabs 570 may include one or more of colors, lines, letters, numbers, patterns, ribs, and / or grooves to indicate one or more of the name of the component, the grouping of the component, and / or toxicity, as discussed herein. The tabs 570 may have one or more of a flagged configuration directly attached to an insert (as illustrated in the embodiment of FIGS. 20- 23), a label or tape secured (e.g., adhered) directly or indirectly to the component or its packaging optionally in a flagged configuration (as illustrated in FIGS. 27-30), a label or tape secured (e.g., adhered) directly or indirectly to the tray 530 (570’ as illustrated in the embodiment of FIG. 31), and / or combinations thereof.

[0203] FIGS. 32-39 illustrate a sixth embodiment of a kit 600. Similar to one or more of the first through fifth embodiments, the kit 600 may include a container 602, a tray 630, and the medicament delivery assembly. The tray 630 may be packaged in the container 602. The tray 630 may have a plurality of compartments containing the components of the medicament delivery system. The tray 630 may include a first compartment 632 containing the pre-filled syringe 200, a second compartment 634 containing the transfer needle 220 (or 220’), and a third compartment 636 containing the vial 230. The tray 630 may further include a fourth compartment 638 containing the vial adapter 240 (or 240’), a fifth compartment 640 containing the dosing syringe 260, and a sixth compartment 642 containing the dosing syringe 260. The kit 600 may provide a clear, intuitive layout of the medicament delivery system to ensure that the user has a clear understanding of the medicament and to provide a clear navigation through the administration of olanzapine, as discussed above with respect to one or more of the first through fifth embodiments, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0204] As illustrated, the tray 630 may include a first tray portion 630a and a second tray portion 630b detachably coupled. The assembly of the first tray portion 630a and the second tray portion 630b may separate the components of the medicament delivery system by function and phase. Thefirst tray portion 630a and the second tray portion 630b may provide vertical and horizontal arrangements of the components to ensure access of the components in the intended sequence. Thus, the first tray portion 630a may be for preparation and reconstitution of the medicament, and the second tray portion 630b may be for dosing the medicament. The first tray portion 630a may receive the first group of components, such as the pre-filled syringe 200, the transfer needle 220, and / or the vial 230, and the second tray portion 630b may receive the second group of components, such as the vial adapter 240, the dosing syringe 260, and / or the dosing needle 270.

[0205] The first tray portion 630a may at least partially overlay the second tray portion 630b when assembled in the container 602 to ensure that the components of the first group are accessed before the components of the second group. For example, only a part of the first tray portion 630a may overlay a part of the second tray portion 630b to provide the vertical and horizontal arrangement, as illustrated in FIGS. 32-39. The first tray portion 630a may include a lateral protrusion 644, and the second tray portion 630b may include a recess 645, where the lateral protrusion 644 is received in the recess 645 when the first tray portion 630a and the second tray portion 630b are assembled together. The first tray portion 630a may further include a lip 646 extending from the lateral protrusion 644 and configured to extend over a part of the second tray portion 630b. The lip 646 may facilitate removal of the first tray portion 630a by providing a surface for a finger grip, while leaving the second tray portion 630b in the container 602. The overlay of the first tray portion 630a with respect to the second tray portion 630b may physically hinder the second group of components from being removed prior to the first group of components and / or the first tray portion 630a. The overlay of the first tray portion 630a with respect to the second tray portion 630b may additionally or alternatively provided a clear visual indicator to the user of the order of operation.

[0206] The kit 600 may include one or more partitions 660, 662, 664 configured to provide information and / or further indicate the order of operation of the medicament delivery system. The kit 600 may include a first partition 660 and a second partition 662 in the first tray portion 630a and a third partition 664 in the second tray portion 630b. As illustrated in FIG. 34, the first partition 660 may overlay the warming pack 280, which may overlay the pre-filled syringe 200 and the second partition 662. The second partition 662 may overlay the transfer needle 220 and the vial 230. The first tray portion 630a may overlay the second partition 662, and as further illustrated in FIG. 37, the third partition 664 may overlay the vial adapter 240, the dosing syringe 260, and / or the dosing needle 270.

[0207] Similar to the first and second partitions 360, 362, the partitions 660-664 may include one or more indicia providing information to the user. The first partition 660 may include a first indicia, and the third partition 664 may include a third indicia, where the first indicia and the third indicia are different. For example, the first indicia may readily identify the first group of components and their intended use in preparing the medicament. The third indicia may readilyidentify the second group of components and their intended use in dosing the medicament. The indicia may include distinct colors, lines, letters, numbers, patterns, ribs, and / or grooves, as discussed with respect to at least one of the first through fifth embodiments, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0208] The first partition 660 and / or the second partition 662 may include information such as instructions on the preparation and / or reconstitution of the medicament. For example, the first partition 660 may include instructions on preparation due to the position overlaying the warming pack 280 and the pre-filled syringe 200. The first partition 660 and / or the second partition 662 may include instructions on reconstitution due to the position overlaying the transfer needle 220 and the vial 230. The third partition 664 may include information on the dosing due to the position overlaying the vial adapter 240, the dosing syringe 260, and the dosing needle 270.

[0209] Thus, the kit 600 may separate the components of the medicament delivery device by function and phase of use into at least two separate tray portions 630a, b. The tray portions 630a, b use vertical and horizontal arrangements to ensure components are accessed in sequence through the tray portions 630a, b and / or partitions 660, 662, 664 uncovering components in a sequence according to the intended use.

[0210] FIGS. 40-44 illustrate a seventh embodiment of a kit 700. Similar to at least one of the first through sixth embodiments, the kit 700 may include a container 702, a first tray 730, a second tray 731, and the medicament delivery assembly. The first tray 730 and the second tray 731 may be packaged in the container 702. The trays 730, 731 may have a plurality of compartments containing the components of the medicament delivery system. The first tray 730 may include a first compartment 732 containing the pre-filled syringe 200, a second compartment 734 containing the transfer needle 220 (or 220’), and a third compartment 736 containing the vial 230. The second tray 731 may further include a fourth compartment 738 containing the vial adapter 240 (or 240’), a fifth compartment 740 containing the dosing syringe 260, and a sixth compartment 742 containing the dosing needle 270. The kit 700 may provide a clear, intuitive layout of the medicament delivery system to ensure that the user has a clear understanding of the medicament and to provide a clear navigation through the administration of olanzapine, as discussed above with respect to at least one of the first through sixth embodiments, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0211] As illustrated, the container 702 may include a box formed by a plurality of panels and having a first enclosure that receives the first tray 730 and a second enclosure that receives the second tray 731. The panels may include a plurality of vertical panels extending vertically from a bottom panel (not shown) to define the enclosure. The vertical panels may include a front panel 704, a pair of side panels 706, and a rear panel (not shown).

[0212] The container 702 may further include a panel in the form of a lid 708 configured to cover the enclosure during storage and shipment. The lid 708 may be pivotably attached to one ofthe side panels 706. A flap 710 may be pivotably attached to the lid 708 and be configured to attach to the front panel 704 to secure the container 102 in a closed configuration. The flap 710 may be releasably secured to one or more of the front panel 704 and / or side panels 706, for example, with an adhesive and / or a heat seal that can be broken by the user to pivot the lid 708 into an open configuration. The lid 708 may include additional panels to form the second enclosure. The second enclosure may be formed by first and second side panels 712 extending from the lid 708 and a horizontal panel 714 extending between the side panels 712. As illustrated in FIG. 44, the second enclosure of the lid 708 may be in the form of a sleeve that slidably receive the second tray 731. The horizontal panel 714 may overlay at least a portion of the second tray 731 to retain the second tray 731 in the second enclosure, while allowing access to the compartments 738-742. The ends of the second enclosure may further be closed by additional panels or flaps 716 that prevent the second tray 731 from sliding out of the second enclosure. The front panel 704 and the rear panel may have the same length, and the side panels 706 may have the same length to form a square or rectangular cross-section. In some embodiments, the length of the front panel 704 and the rear panel may be shorter than the length of the side panels 706 to provide a favorable rectangular layout of the components, as illustrated in FIG. 41. For example, the container 702 when closed may have a width of about 140 mm defined by the front panel 704, and a length of about 190 mm defined by the side panels 706.

[0213] An insert 750 may be in the form of a panel pivotably attached to the container 702, for example at one of the side panels 706. The insert 750 may have an open configuration pivoted away from the container 702 for access to the first enclosure, for example for insertion of the first tray 730. The insert 750 may have a closed configuration covering the first tray 730 when inserted in the first enclosure. After insertion of the first tray 730, the insert 750 may be secured to prevent removal of the first tray 730 in the closed configuration, for example with an adhesive and / or a heat seal. The insert 750 may be attached to an intermediate panel 718 at a first pivot, and the intermediate panel 718 may be attached to the container 702 at a second pivot, allowing the insert 750 to be recessed in the first enclosure in the closed configuration and the lid 708 to be received in the first enclosure in a closed configuration. The insert 750 may include one or openings 760 aligned with the compartments 732-736 of the first tray 730, and the horizontal panel 714 may include one or openings 715 aligned with the compartments 738-742 of the second tray 731.

[0214] The insert 750 and the horizontal panel 714 may include one or more indicia providing information to the user. The insert 750 may include a first indicia, and the horizontal panel 714 may include a second indicia, where the first indicia and the second indicia are different. For example, the first indicia may readily identify the first group of components and their intended use in preparing the medicament. The second indicia may readily identify the second group of components and their intended use in dosing the medicament. The indicia may include distinct colors, lines, letters, numbers, patterns, ribs, and / or grooves, as discussed with respect to at leastone of the first through sixth embodiments, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0215] Thus, the kit 700 provides a fold out box format that exploits both format and indicia to logically guide the user through the reconstitution and administration process. The kit 700 provides an improved opening experience that opens in a familiar order from left to right. The indicia may provide a graphic quick reference guide next to each component and color and graphics to highlight and differentiate key stages.

[0216] FIG. 45 illustrates an eighth embodiment of a kit 800. Similar to at least one of the first through seventh embodiments, the kit 800 may include a container 802, at least one tray 830, an insert 850, and a medicament delivery system. The at least one tray 830 may be packaged in the container 802. The medicament delivery system may be as illustrated and discussed with reference to FIG. 11. The at least one tray 830 may have a plurality of compartments containing the components of the medicament delivery system. The at least one tray may include a first compartment 832 containing the pre-filled syringe 200, a second compartment 834 containing the first transfer needle 220 (or 220’), and a third compartment 836 containing the vial 230. The at least one tray may further include a fourth compartment 838 containing the second transfer needle 220”, a fifth compartment 840 containing the dosing syringe 260, and a sixth compartment 842 containing the dosing needle 270. The kit 800 may provide a clear, intuitive layout of the medicament delivery system to ensure that the user has a clear understanding of the medicament and to provide a clear navigation through the administration of olanzapine, as discussed above with respect to at least one of the first through seventh embodiments, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0217] As further discussed with reference to the first embodiment, the tray 830 and / or the insert 850 may provide an intuitive layout of the medicament delivery system to provide a clear navigation through the preparation and administration of the medicament. The layout may also organize the components of the medicament delivery system into multiple distinct groups corresponding to respective steps in the preparation, reconstitution, and delivery of olanzapine. A first group may include components for preparing the diluent. A second group may include components for preparing the medicament, such as reconstituting the powder or lyophilized medicament. A third group may include components for transferring the prepared medicament to a syringe. A fourth group may include components for administering the reconstituted medicament. For example, the first group may include the pre-filled syringe 200, and the second group may include the first transfer needle 220’ and the vial 230. The third group may include the second transfer needle 220’ and the dosing syringe 260, and the fourth group may include the dosing needle 270. The layout may further indicate an order of operation for the components to minimize a possibility of the user performing steps out of order.

[0218] In some embodiments, the at least one tray 830 may spatially indicate the order of operation based on the layout of the components of the medicament delivery system, for example from left to right. The first compartment 832 may be on a first portion of the tray 130. The second compartment 834 and the third compartment 836 may be on a second portion of the tray 830. The fourth compartment 838 and the fifth compartment 840 may be on a third portion of the tray 830. The sixth compartment 842 may be on a fourth portion of the tray 830. The first portion and the fourth portion may be on opposite sides of the tray 830, for example on opposite sides with respect to the long dimension defined by the front panel 804 and the rear panel. In some embodiments, the second portion and the third portion may be between the first portion and the fourth portion spatially separating the first portion and the fourth portion. The layout may approximate the prefilled syringe 200 and the transfer needle 220 and approximate the dosing syringe 260 and the dosing needle 270 to clarify that the pre-filled syringe 200 and the transfer needle 220 are to be used together and the dosing syringe 260 and the dosing needle 270 are to be used together. The layout may spatially separate the pre-filled syringe 200 and the dosing syringe 260 and spatially separate the transfer needle 220 and the dosing needle 270 to prevent confusion of the user in the operation of each component. Furthermore, when the container 102 is opened by the user in a proper orientation (for example indicated by the orientation of text), the first portion may be on a left side of the tray 830. The second portion may be between the first portion and the third portion. The third portion may be between the second portion and the fourth portion, and the fourth portion may be on a right side of the tray 830. Thus, the spatial layout of the components may indicate to the user to first remove the pre-filled syringe 200 from the tray 830, followed by the first transfer needle 220’, followed by the vial 230 and then the second transfer needleand then the dosing syringe 260 and the dosing needle 270.

[0219] The kit 100 may, additionally or alternatively, include one or more indicia 852-858 printed, formed, or otherwise disposed on or overlaying the tray 830 (z.e., on the insert 850) that visually groups the components of the medicament delivery system and / or indicates an order of operation of the components. The one or more indicia may include distinct colors, lines, letters, numbers, patterns, ribs, and / or grooves. The kit 800 may have a first indicia 852 associated with the first group of components of the medicament delivery system, a second indicia 854 associated with the second group of components of the medicament delivery system, a third indicia 856 associated with the third group of components, a fourth indicia 858 associated with the fourth group of components. The indicia may embody distinctive colors and / or patterns. For example, the first indicia 852 may be purple, the second indicia 854 may be green, the third indicia 856 may be red, and the fourth indicia 858 may be orange, however any distinct set of colors may be used. The indicia 852-858 may be solid colors on the tray 830 around the respective compartments 832- 842. Alternatively, the indicia 852-858 may be patterns, such as hatching or cross-hatching ofdistinctive patterns. The indicia 852-858 may collectively cover substantially the entire surface of the insert 850 around the respective groups of components.

[0220] The indicia may, additionally or alternatively, include symbols 870 associated with the components indicating the order of operation. The symbols 870 may include letters and / or numbers sequentially and / or progressively associated with the components based on the order of operation. The numbers may include natural numbers, integers, roman numerals, triangular numbers, decimals, fractions, and / or dot accumulations. The letters may be based on an alphabet of any language, including the English alphabet, the Latin alphabet, and / or the Greek alphabet. The symbols 870 may be coded based on the indicia. For example, the first group may be indicated by a symbol 870 comprising a number “1”, the second group may be indicated by a symbol 870 comprising a number “2”, and the third group may be indicated by a symbol 870 comprising a number “3”, and the fourth group may be indicated by a symbol 870 comprising a number “4”.

[0221] The indicia may be formed, printed, or otherwise disposed on the insert 850 positioned in the container 802 overlying the tray 830. The insert 850 may be a standalone flat sheet or panel, as illustrated in FIG. 4. Alternatively, the insert 850 may be a flat sheet or panel of a three- dimensional structure, such as a sleeve that receives the tray 830 as illustrated in FIG. 18. The insert 850 may be attached to the tray 830, such as through adhesive, or rest upon the surface of the tray 830. In some embodiments, the insert 850 may be omitted or be a part of the tray 830, such that the indicia may be formed or printed directly on the tray 830 itself. The insert 850 may, additionally or alternatively, be directly attached to the container 802, such as being pivotably attached to the front panel 804, as illustrated with a central panel 416 in FIGS. 19-20. The insert 850 may be made of paper of a card stock or plastic, and the tray 830 may be made of a plastic, Paperfoam, or a Styrofoam material.

[0222] As illustrated, the container 802 may include a box formed by a plurality of panels and having a first enclosure that receives the at least one tray. The panels may include a plurality of vertical panels extending vertically from a bottom panel (not shown) to define the enclosure. The vertical panels may include a front panel 804, a pair of side panels, and a rear panel (not shown). The container 802 may further include a panel in the form of a lid 808 configured to cover the enclosure during storage and shipment. The lid 808 may be pivotably attached to the rear panel.

[0223] The lid 808 may have an inner surface that is exposed to the user when the container 802 is opened. The inner surface may have a first region 873 including information associated with the first group of components, such as the pre-filled syringe 200, for example including instructions for preparing (i.e., warming) the diluent. The inner surface may have a second region 874 including information associated with the second group of components, the transfer needle 220, and / or the vial 230, for example including instructions for preparing (i.e., reconstituting) the medicament. The inner surface may have a third region 875 including information associated with the third group of components including the second transfer needle 220” and the dosing syringe 260, forexample including instructions for withdrawing the medicament from the vial 230. The inner surface may have a fourth region 876 including information associated with the fourth group of components including the dosing needle 270, for example including instructions for administering the medicament. The first region 873 may include the first indicia similar to the insert 150, the second region 874 may include the second indicia similar to the insert 150, the third region 875 may include the third indicia similar to the insert 150, and the fourth region 876 may include the fourth indicia similar to the insert 150. As illustrated, the first region 873 may include a one or more first lines forming a box around the instructions for preparing the diluent, where the one or more first lines may be correlated to the first indicia of the insert 850 (e.g., matching the color of the first indicia). The second region 874 may include a one or more second lines forming a box around the instructions for preparing the medicament, where the one or more second lines may be correlated to the second indicia of the insert 850 (e.g., matching the color of the second indicia). The third region 875 may include a one or more third lines forming a box around the instructions for withdrawing the medicament, where the one or more third lines may be correlated to the third indicia of the insert 850 (e.g. , matching the color of the third indicia). The fourth region 876 may include a one or more fourth lines forming a box around the instructions for preparing the medicament, where the one or more fourth lines may be correlated to the second indicia of the insert 850 (e.g., matching the color of the second indicia). When the lid 808 is opened, the first region 873 may be substantially aligned with the first compartment 832, the second region 874 may be substantially aligned with the second compartment 834 and / or the third compartment 836, the third region 875 may be substantially aligned with the fourth compartment 838 and / or the fifth compartment 840, and the fourth region 876 may be substantially aligned with the sixth compartment 842. Thus, the user may readily associate the information from the first region 873 of the lid 808 with the first group of components, the information from the second region 874 of the lid 808 with the second group of components, the information from the third region 875 of the lid 808 with the third group of components, and the information from the fourth region 876 of the lid 808 with the fourth group of components. The information from the regions 873-876 may provide a quick reference guide to the user.

[0224] The kit 800 may, additionally or alternatively, include a sheet 191 providing a quick reference guide. The sheet 191 may include one or more regions similar to the regions 873-876 of the lid 808, and include similar indicia as discussed with reference to the lid 808. For example, the sheet 191 may include four regions 191A-D corresponding to the number of groups of components. In some embodiments, the regions of the sheet 191 may not include instructions but rather include the groupings of the components. For example, the regions 191A-D of the sheet may include visual representation and / or descriptions of the components in each of the respective groups of components. For example, a first region 191 A of the sheet 191 may include a first region including a visual representation and / or description of the pre-filled syringe 200, a second region 19 IBincluding a visual representation and / or description of the first transfer needle 220’ and the vial 230, a third region 191C including a visual representation and / or description of the second transfer needle 220” and the dosing syringe 260, and a fourth region 191D including a visual representation and / or description of the dosing needle 270. The sheet 191 may be placed inside the container 802 between the tray 830 and the lid 808, for example, above the warming pack 280 and the information sheet or booklet 191 and underneath the lid 808. The sheet 191 may provide additional clarity to the user of the order of processes with respect to the components. The regions 191A-D of the sheet 191 may be laterally arranged similar to the regions 873-876 of the lid 808. Thus, the user may lay the sheet 191 underneath or above the container 802 such that the regions of the sheet 191 may be vertically aligned with the respective groups of components.

[0225] FIG. 46 illustrates a ninth embodiment of a kit 900. Similar to at least one of the first through eighth embodiments, the kit 900 may include a container 902, at least one tray 930, an insert 950, and a medicament delivery system. The at least one tray may be packaged in the container 902. The medicament delivery system may be as illustrated and discussed with reference to FIG. 6. The at least one tray 930 may have a plurality of compartments containing the components of the medicament delivery system. The at least one tray may include a first compartment 932 containing the pre-filled syringe 200, a second compartment 934 containing the vial 230, and a third compartment 936 containing the vial adapter 240. The at least one tray may further include a fourth compartment 938 containing the dosing syringe 260 and a fifth compartment 940 containing the dosing needle 270. The kit 900 may provide a clear, intuitive layout of the medicament delivery system to ensure that the user has a clear understanding of the medicament and to provide a clear navigation through the administration of olanzapine, as discussed above with respect to at least one of the first through eighth embodiments, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0226] As further discussed with reference to the eighth embodiment, the tray 930 and / or the insert 950 may provide an intuitive layout of the medicament delivery system to provide a clear navigation through the preparation and administration of the medicament. The layout may also organize the components of the medicament delivery system into multiple distinct groups. A first group may include components for preparing (i.e., warming) the diluent. A second group may include components for preparing the medicament, such as reconstituting the powder or lyophilized medicament. A third group may include components for transferring the prepared medicament to a syringe. A fourth group may include components for administering the reconstituted medicament. For example, the first group may include the pre-filled syringe 200, and the second group may include the vial 230 and the vial adapter 240. The third group may include the dosing syringe 260, and the fourth group may include the dosing needle 270. The layout may further indicate an order of operation for the components to minimize a possibility of the user performing steps out of order.

[0227] As further discussed with reference to the eighth embodiment, the at least one tray 930 may spatially indicate the order of operation based on the layout of the components of the medicament delivery system, for example from left to right. The kit 900 may, additionally or alternatively, include one or more indicia 952-958 printed, formed, or otherwise disposed on or overlaying the tray 930 (z.e., on the insert 950) that visually groups the components of the medicament delivery system and / or indicates an order of operation of the components. The indicia may, additionally or alternatively, include symbols 970 associated with the components indicating the order of operation. A lid 908 of the container 902 may have an inner surface that includes regions 973-976 including information associated with the respective group of components, such as instructions for use. The kit 900 may, additionally or alternatively, include a sheet 191 providing a quick reference guide, such groupings of the components.

[0228] FIGS. 47-48 illustrate a tenth embodiment of a kit 1100 according to the present disclosure. Similar to at least one of the first through ninth embodiments, the kit 1100 may include a container 1102, at least one tray 1130, and a medicament delivery system. The at least one tray 1130 may be packaged in the container 1102. The medicament delivery system may be as illustrated and discussed with reference to FIG. 6. The at least one tray 1130 may have a plurality of compartments containing the components of the medicament delivery system. The at least one tray may include a first compartment 1132 containing the pre-filled syringe 200, a second compartment 1134 containing the vial 230, and a third compartment 1136 containing the vial adapter 240. The at least one tray may further include a fourth compartment 1138 containing the dosing syringe 260 and a fifth compartment 1140 containing the dosing needle 270. The kit 1100 may provide a clear, intuitive layout of the medicament delivery system to ensure that the user has a clear understanding of the medicament and to provide a clear navigation through the administration of olanzapine, as discussed above with respect to at least one of the first through eighth embodiments, the entire disclosure of which is expressly incorporated herein for sake brevity.

[0229] As further discussed with reference to the eighth and ninth embodiments, the tray 1130 may provide an intuitive layout of the medicament delivery system to provide a clear navigation through the preparation and administration of the medicament. The layout may also organize the components of the medicament delivery system into multiple distinct groups. A first group may include components for preparing (i.e., warming) the diluent. A second group may include components for preparing the medicament, such as reconstituting the powder or lyophilized medicament. A third group may include components for transferring the prepared medicament to a syringe. A fourth group may include components for administering the reconstituted medicament. For example, the first group may include the pre-filled syringe 200, and the second group may include the vial 230 and the vial adapter 240. The third group may include the dosing syringe 260,and the fourth group may include the dosing needle 270. The layout may further indicate an order of operation for the components to minimize a possibility of the user performing steps out of order.

[0230] However, the kit 1100 does not include an insert attached to or overlaying the tray 1150. Instead of an insert, the indicia that visually groups the components of the medicament delivery system and / or indicates an order of operation of the components may be printed directly on the tray 1150, for example by inkjet printing. Omission of a separate insert containing the indicia provides several benefits. For example, printing the indicia directly on the tray 1150 simplifies construction and assembly of the kit, as well as obviates the risk of an insert detaching from the tray 1150 prior to or during use of the kit 1100. Further, printing the indicia directly onto the tray 1150 and omitting an insert allows for stacking of the trays 1150 (see FIG. 48) prior to assembly of the kit 1100, providing significant space savings during storage and delivery prior to kit assembly.

[0231] As further discussed with reference to the eighth and ninth embodiments, the at least one tray 1130 may spatially indicate the order of operation based on the layout of the components of the medicament delivery system, for example from left to right. The kit 1100 may, additionally or alternatively, include one or more indicia 1152-1158 printed on the tray 1150 (see FIG. 47) that visually groups the components of the medicament delivery system and / or indicates an order of operation of the components. The indicia 1152-1158 may comprise areas having different colors and / or patterns. In FIG. 48, the different areas are shown as areas of different shading to represent different colors, and boundaries between the areas are indicated with a broken line. The indicia may, additionally or alternatively, include symbols 1170 associated with the components indicating the order of operation. A lid 1108 of the container 1102 may have an inner surface that includes regions 1173-1176 including information associated with the respective group of components, such as instructions for use. The kit 1100 may, additionally or alternatively, include a sheet 1191 providing a quick reference guide, such groupings of the components.

[0232] Additionally, the third compartment 1136 of the tray may include a first recessed area 1136a and a second recessed area 1136b, where each of the first and second recessed areas 1136a, 1136b are configured to receive distinct portions of packaging 275 of the vial adapter 240. Packaging 275 can include a first section 275a configured to substantially receive the vial adapter 275. The first section 275a can be substantially rigid and transparent. The second section 275b can comprise paper or a similar material configured to seal the vial adapter 240 within the first section 275a. When disposed within the tray 1130, the first section 275a of the packaging can be received within the first recessed area 1136a, and the second section 275b of the packaging can be received within the second recessed area 1136b. This allows the second section 275b of the packaging to lay substantially flush with the upper surface of the tray, while allowing a user to view any instructions or labels printed on the second section 275b.

[0233] While systems and methods have been described in connection with the various embodiments of the various figures, it will be appreciated by those skilled in the art that changescould be made to the embodiments without departing from the broad inventive concept thereof. It is understood, therefore, that this disclosure is not limited to the particular embodiments disclosed, and it is intended to cover modifications within the spirit and scope of the present disclosure as defined by the claims.

[0234] Throughout this disclosure, numerical values have been used. Each such numerical value should be interpreted as meaning the numerical value itself or as meaning the numerical value qualified by the term “about”. For example, a numerical range of “from X to Y” is to be interpreted according to this disclosure as meaning “from X to Y” or “from about X to about Y”.

[0235] The following further embodiments form part of the present disclosure:1. A kit comprising: a container; at least one tray disposed in the container; a pre-filled syringe containing a diluent comprising a biodegradable polymer excipient, the pre-filled syringe being disposed in a first compartment of the at least one tray; a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof, the vial being disposed in a second compartment of the at least one tray; a dosing syringe configured to administer the medicament, the dosing syringe being disposed in a third compartment of the at least one tray; a dosing needle configured to be attached to the dosing syringe, the dosing needle being disposed in a fourth compartment of the at least one tray; a first indicia on or overlaying the at least one tray visually corresponding to the first compartment; and a second indicia on or overlaying the at least one tray visually corresponding to the second compartment, wherein the second indicia is different than the first indicia.2. The kit of embodiment 1, further comprising a transfer needle configured to be attached to the pre-filled syringe, the transfer needle being disposed in a compartment of the at least one tray.3. The kit of embodiment 2, wherein the second indicia groups the second compartment and the compartment containing the transfer needle.4. The kit of at least one of the preceding embodiments, further comprising a vial adapter configured to be attached to the vial, the vial adapter being disposed in a compartment of the at least one tray.5. The kit of embodiment 4, wherein the second indicia groups the second compartment and the compartment containing the vial adapter.6. The kit of embodiment 4 or 5, wherein the second compartment and the compartment containing the vial adapter are on a third portion of the at least one tray, and the third portion is between a first portion having the first compartment and the compartment containing the transfer needle and a second portion having the third compartment and the fourth compartment.7. The kit of at least one of embodiments 1-3, further comprising a second transfer needle configured to be attached to the dosing syringe, the second transfer needle being disposed in a compartment of the at least one tray.8. The kit of embodiment 7, further comprising a third indicia on or overlaying the at least one tray visually grouping the third compartment and the compartment and the compartment containing the second transfer needle.9. The kit of embodiment 7 or 8, wherein the transfer needle is smaller than the second transfer needle.10. The kit of embodiment 9, wherein the transfer needle is 21 gauge, and the second transfer needle is 19 gauge.11. The kit of embodiment 7 or 8, wherein the transfer needle and the second transfer needle are both 19 gauge.12. The kit of embodiment 11, wherein the transfer needle, the second transfer needle, and the dosing needle are each 19 gauge.13. The kit of at least one of the preceding embodiments, further comprising: a third indicia on or overlaying the at least one tray visually corresponding to the third compartment, and a fourth indicia on or overlaying the at least one tray visually corresponding to the third compartment.14. The kit of embodiment 13, wherein the third indicia is positioned on or overlaying the at least one tray between the first and second indicia, and the third indicia is positioned on or overlaying the at least one tray between the second and fourth indicia.15. The kit of at least one of the preceding embodiments, further comprising: a first symbol on or overlaying the at least one tray, the first symbol corresponding to the first indicia; a second symbol on or overlaying the at least one tray, the second symbol corresponding to the second indicia; a third symbol on or overlaying the at least one tray, the first symbol corresponding to the third indicia; and a fourth symbol on or overlaying the at least one tray, the fourth symbol corresponding to the fourth indicia.16. The kit of embodiment 15, further comprising a plurality of arrows on or overlaying the at least one tray, wherein each of the arrows extends between one of the symbols and the corresponding one of the compartments.17. The kit of at least one of the preceding embodiments, wherein the first compartment and the compartment containing the transfer needle are on a first portion of the at least one tray, thethird compartment and the fourth compartment are on a second portion of the at least one tray, and the first portion and the second portion are on opposite sides of the at least one tray.18. The kit of at least one of the preceding embodiments, wherein the first compartment and the compartment containing the transfer needle are arranged in a parallel orientation.19. The kit of at least one of the preceding embodiments, wherein a recess in the at least one tray connects the first compartment and the second compartment.20. The kit of at least one of the preceding embodiments, wherein the third compartment and the fourth compartment are arranged in a parallel orientation.21. The kit of at least one of the preceding embodiments, wherein a recess in the at least one tray connects the third compartment and the fourth compartment.22. The kit of at least one of the preceding embodiments, further comprising a warming pack disposed over the at least one tray.23. The kit of embodiment 22, wherein the warming pack is disposed over at least a portion of the first compartment.24. The kit of embodiment 22 or 23, further comprising a booklet disposed over the at least one tray, the booklet including instructions for using the kit.25. The kit of embodiment 24, further comprising one or more ribs configured to laterally separate and secure the booklet and the warming pack.26. The kit of at least one of the preceding embodiments, further comprising a sheet disposed over the at least one tray, the sheet including a quick reference guide for using the kit.27. The kit of at least one of embodiments 22-26, wherein the warming pack includes at least one securement portion configured to secure the warming pack around the pre-filled syringe.28. The kit of embodiment 27, wherein the at least one securement portion includes a first portion having a plurality of hook structures and a second portion having a plurality of loop structures.29. The kit of claim at least one of embodiments 22-28, wherein the warming pack includes an insert configured to activate a solution inside of the warming pack to generate an exothermic reaction.30. The kit of at least one of the preceding embodiments, wherein the at least one tray is separable from the container.31. The kit of at least one of the preceding embodiments, wherein the container is a box including an enclosure and a lid, wherein the lid is configured to be opened to access the enclosure.32. The kit of at least one of the preceding embodiments, wherein the warming pack and the sheet are positioned between the tray and the lid when the lid is in a closed configuration.33. The kit of embodiment 31 or 32, wherein the lid has at least one panel defining a second enclosure, and the second enclosure is received in the first enclosure when the container is closed.34. The kit of embodiment 33, wherein the at least one tray includes a first tray and a second tray, the first tray is received in the enclosure, and the second tray is received in the second enclosure.35. The kit of at least one of the preceding embodiments, wherein at least one of the dosing syringe, the dosing needle, the transfer needle, the vial adapter, and the second transfer needle are separately enclosed by an individual package.36. The kit of embodiment 35, wherein the dosing syringe is in a first package, the dosing needle is in a second package, and each of the first package and the second package have a flat back disposed in a vertical orientation with respect to the at least one tray.37. The kit of embodiment 36, wherein the transfer needle is in a third package having a flat back disposed in a horizontal orientation with respect to the at least one tray.38. The kit of embodiment 36 or 37, wherein the vial adapter is in a fourth package having a flat back disposed in a horizontal orientation with respect to the at least one tray.39. The kit of at least one of the preceding embodiments, wherein at least one of the individual package, the first package, and the second package are a blister pack.40. The kit of at least one of the preceding embodiments, wherein the vial is individually packaged in a box.41. The kit of at least one of the preceding embodiments, further comprising an insert disposed over the at least one tray, and the first indicia and the second indicia are formed or printed on the insert.42. The kit of embodiment 41, wherein the insert includes one or more openings aligned with the compartments.43. The kit of embodiment 41 or 42, wherein the insert includes a first opening aligned with the first compartment and the compartment including the transfer needle and a second opening aligned with the third compartment and the fourth compartment.44. The kit of at least one of embodiments 41-43, wherein the insert includes a third opening aligned with the second compartment and a fourth opening aligned with the compartment containing the vial adapter.45. The kit of at least one of the preceding embodiments, wherein the first indicia includes at least one first ring disposed at least partially around at least one of the first compartment and the second compartment, and the second indicia includes at least one second ring disposed at least partially around at least one of the third compartment and the fourth compartment.46. The kit of at least one of embodiments 41-45, wherein the at least one first ring is a first color and / or pattern, and the at least one second ring is a second color and / or pattern.47. The kit of embodiment 45 or 46, wherein the at least one first ring includes a ring around the first compartment and the compartment receiving the transfer needle and a ring around the second compartment, andwherein the at least one second ring includes a ring around the compartment receiving the vial adapter and a ring around the third and fourth compartments.48. The kit of at least one of embodiments 41-47, wherein the insert includes: a first partition attached at a first perforation and covering the pre-filled syringe and the vial, a second partition attached at a second perforation and covering the dosing syringe and the dosing needle, and the first partition and the second partition are individually openable.49. The kit of at least one of the preceding embodiments, wherein the insert is in the form of a sleeve that receives the at least one tray.50. The kit of at least one of the preceding embodiments, wherein the container has a central panel pivotably attached to the container, the central panel having a third indicia formed or disposed around a first portion, the third indicia corresponding to the first indicia, and a fourth indicia formed or disposed around a second portion, the fourth indicia corresponding to the second indicia.51. The kit of at least one of the preceding embodiments, further comprising a tab disposed over at least one of the compartments, wherein the tab is configured to deflect when a user removes a component from the respective compartment.52. The kit of at least one of the preceding embodiments, wherein the at least one tray includes a first tray portion and a second tray portion, the first compartment and the second compartment are in the first tray portion, the third compartment and the fourth compartment are in the second tray portion, and the first tray portion and the second tray portion are separable.53. The kit of embodiment 52, wherein the first tray portion at least partially overlies the second tray portion.54. The kit of at least one of the preceding embodiments, wherein the dosing needle is covered with a needle sheath and is attached to a safety shield.55. The kit of at least one of the preceding embodiments, wherein the diluent includes an organic solvent.56. The kit of embodiment 55, wherein the organic solvent is dimethylsulfoxide (DMSO).57. The kit of at least one of the preceding embodiments, wherein the diluent has a melting point above 8°C.58. A kit comprising : a container; at least one tray disposed in the container; a pre-filled syringe containing a diluent comprising a biodegradable polymer excipient, the pre-filled syringe being disposed in a first compartment of the at least one tray;a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof, the vial being disposed in a second compartment of the at least one tray; a dosing syringe configured to administer the medicament, the second syringe being disposed in a third compartment of the at least one tray; a dosing needle configured to be attached to the dosing syringe, the dosing needle being disposed in a fourth compartment of the at least one tray; and a warming pack.59. The kit of embodiment 58, wherein the warming pack is disposed over the at least one tray.60. The kit of embodiment 58 or 59, wherein the warming pack includes an insert configured to active a solution inside of the warming pack to generate an exothermic reaction.61. The kit of at least one of embodiments 58-60, further comprising a transfer needle configured to be attached to the pre-filled syringe, the transfer needle being disposed in a compartment of the at least one tray.62. The kit of at least one of embodiments 58-61, further comprising a vial adapter configured to be attached to the vial, the vial adapter being disposed in a compartment of the at least one tray.63. The kit of at least one of embodiments 58-62, further comprising a second transfer needle configured to be attached to the dosing syringe, the second transfer needle being disposed in a compartment of the at least one tray.64. The kit of at least one of embodiments 58-63, wherein the first compartment and the compartment containing the transfer needle are on a first portion of the at least one tray, the third compartment and the fourth compartment are on a second portion of the at least one tray, and the first portion and the second portion are on opposite sides of the at least one tray.65. The kit of at least one of embodiments 58-64, wherein the second compartment and the compartment containing the vial adapter are on a third portion of the at least one tray, and the third portion is between the first portion and the second portion.66. The kit of at least one of embodiments 58-65, wherein the warming pack includes at least one securement portion configured to secure the warming pack around the pre-filled syringe.67. The kit of embodiment 66, wherein the at least one securement portion includes a first portion having a plurality of hook structures and a second portion having a plurality of loop structures.68. The kit of at least one of embodiments 58-67, wherein the diluent includes an organic solvent.69. The kit of embodiment 68, wherein the organic solvent is dimethylsulfoxide (DMSO).70. The kit of at least one of embodiments 58-69, wherein the diluent has a melting point above 8°C.71. A method comprising :receiving a pre-filled syringe containing a diluent comprising a biodegradable polymer excipient, a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof, and a warming pack; storing the diluent in a substantially solid state; warming the diluent in the pre-filled syringe with the warming pack; introducing the diluent into the vial to reconstitute the medicament; transferring a dose of the reconstituted medicament from the vial to a dosing syringe; and administering the dose of the reconstituted medicament from the dosing syringe to a patient.72. The method of embodiment 71, wherein the diluent includes an organic solvent.73. The method of embodiment 72, wherein the organic solvent is dimethylsulfoxide (DMSO).74. The method of at least one of embodiments 71-73, wherein storing the diluent in a substantially solid state comprises storing the diluent in an environment at or below 8°C, wherein warming the diluent in the-prefilled syringe includes transitioning the diluent from the substantially solid state into a liquid state.75. The method of one of embodiments 71-74, wherein warming the diluent is to a temperature below body temperature prior to administration.76. The method of embodiments 71-75, wherein warming the diluent is to at least 12°C.77. The method of at least one of embodiments 71-76, further comprising manipulating an insert to generate an exothermic reaction in the warming pack.78. The method of at least one of embodiments 71-77, further comprising securing the warming pack around the pre-filled syringe with at least one securement portion by securing hook structures on a first securement portion onto loop structures on a second securement portion.79. The method of at least one of embodiments 71-78, further comprising: attaching a transfer needle to the pre-filled syringe; and puncturing a stopper of the vial with the transfer needle to introduce the diluent into the vial.80. The method of at least one of embodiments 71-79, wherein the container encloses a vial adapter, and the method further comprises: securing the vial adapter to the vial containing the reconstituted medicament, and attaching the dosing syringe to the vial adapter to transfer the reconstituted medicament to the dosing syringe.81. The method of at least one of embodiments 71-80, wherein the container encloses a vial adapter, and the method further comprises: securing the vial adapter to the vial; attaching the prefilled syringe to the vial adapter to introduce the diluent into the vial; attaching the dosing syringe to the vial adapter after reconstituting the medicament; andtransferring a dose of the reconstituted medicament from the vial to a dosing syringe.82. The method of at least one of embodiments 71-81, further comprising equalizing pressure in the vial after introducing the diluent by pulling back a plunger of the dosing syringe without drawing the diluent.83. A method comprising: receiving a pre-filled syringe containing a diluent and a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof; warming the diluent in the pre-filled syringe; introducing the diluent into the vial to reconstitute the medicament; storing the reconstituted medicament for up to about 24 hours in an environment of 20°C to 25°C; transferring, after storing the reconstituted medicament, a dose of the reconstituted medicament from the vial to a dosing syringe; and administering the dose of the reconstituted medicament from the dosing syringe to a patient.84. The method of embodiment 83, wherein the diluent includes a biodegradable polymer.85. The method of embodiment 83 or 84, wherein the diluent includes an organic solvent.86. The method of embodiment 85, wherein the organic solvent is dimethylsulfoxide (DMSO).87. The method of at least one of embodiments 83-86, further comprising storing the diluent in a solid state in an environment of at or below 8°C.88. The method of at least one of embodiments 83-87, comprising storing the reconstituted medicament for up to 18 hours in an environment of 20°C to 25°C.89. The method of at least one of embodiments 83-88, comprising storing the reconstituted medicament for up to 12 hours in an environment of 20°C to 25 °C.90. The method of at least one of embodiments 83-89, comprising storing the reconstituted medicament for up to 6 hours in an environment of 20°C to 25°C.91. The method of at least one of embodiments 83-90, comprising storing the reconstituted medicament for up to 1 hour in an environment of 20°C to 25°C.92. The method of at least one of embodiments 83-91, comprising storing the reconstituted medicament for at least 1 hour in an environment of 20°C to 25 °C.93. The method of at least one of embodiments 83-90, comprising storing the reconstituted medicament for at least 6 hours in an environment of 20°C to 25°C.94. The method of at least one of embodiments 83-89, comprising storing the reconstituted medicament for at least 12 hours in an environment of 20°C to 25°C.95. The method of at least one of embodiments 83-88, comprising storing the reconstituted medicament for at least 18 hours in an environment of 20°C to 25°C.96. The method of at least one of embodiments 83-95, further comprising attaching a transfer needle to the prefilled syringe, wherein introducing the diluent into the vial comprises piercing a stopper of the vial with the transfer needle.97. The method of embodiment 96, further comprising attaching a second transfer needle to the dosing syringe, wherein transferring the dose of reconstituted medicament comprises piercing the stopper with the second transfer needle.98. The method of embodiment 97, wherein the transfer needle and the second transfer needle are 21 gauge.99. The method of at least one of embodiments 83-95, further comprising: attaching a vial adapter containing a self-sealing valve to the vial, wherein introducing the diluent into the vial comprises attaching the prefdled syringe to the vial adapter, and wherein transferring a dose of the reconstituted medicament from the vial to the dosing syringe comprises attaching the dosing syringe to the vial adapter.100. The method of at least one of embodiments 83-99, further comprising after the storing step, shaking the vial to mix the diluent and the olanzapine or a pharmaceutically acceptable salt thereof.101. The method of embodiment 100, further comprising shaking the vial for about 30 seconds.

Claims

Claims1. A kit comprising: a container; at least one tray disposed in the container; a pre-filled syringe containing a diluent comprising a biodegradable polymer excipient, the pre-filled syringe being disposed in a first compartment of the at least one tray; a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof, the vial being disposed in a second compartment of the at least one tray; a dosing syringe configured to administer the medicament, the dosing syringe being disposed in a third compartment of the at least one tray; a dosing needle configured to be attached to the dosing syringe, the dosing needle being disposed in a fourth compartment of the at least one tray; a first indicia on or overlaying the at least one tray visually corresponding to the first compartment; and a second indicia on or overlaying the at least one tray visually corresponding to the second compartment, wherein the second indicia is different than the first indicia.

2. The kit of claim 1, further comprising a transfer needle configured to be attached to the pre-filled syringe, the transfer needle being disposed in a compartment of the at least one tray.

3. The kit of claim 2, wherein the second indicia groups the second compartment and the compartment containing the transfer needle.

4. The kit of any one of the preceding claims, further comprising a vial adapter configured to be attached to the vial, the vial adapter being disposed in a compartment of the at least one tray.

5. The kit of claim 4, wherein the vial adapter is further configured to be directly attached to the pre-filled syringe for transferring the diluent from the pre-filled syringe to the vial without use of a transfer needle.

6. The kit of claim 4 or 5, wherein the vial adapter is further configured to be directly attached to the dosing syringe for transferring the medication from the vial to the dosing syringe without use of a transfer needle.

7. The kit of any one of claims 4 to 6, wherein the second indicia groups the second compartment and the compartment containing the vial adapter.

8. The kit of any one of claims 4 to 7, wherein the second compartment and the compartment containing the vial adapter are on a third portion of the at least one tray, and the third portion is between a first portion having the first compartment and a second portion having the third compartment and the fourth compartment.

9. The kit of claim 8, wherein the first portion includes the compartment containing the transfer needle.

10. The kit of claim 2 or 3, further comprising a second transfer needle configured to be attached to the dosing syringe, the second transfer needle being disposed in a compartment of the at least one tray.

11. The kit of claim 10, further comprising a third indicia on or overlaying the at least one tray visually grouping the third compartment and the compartment and the compartment containing the second transfer needle.

12. The kit of claim 10 or 11, wherein the transfer needle is smaller than the second transfer needle.

13. The kit of claim 12, wherein the transfer needle is 21 gauge, and the second transfer needle is 19 gauge.

14. The kit of claim 10 or 11, wherein the transfer needle and the second transfer needle are both 19 gauge.

15. The kit of claim 14, wherein the transfer needle, the second transfer needle, and the dosing needle are each 19 gauge.

16. The kit of any one of claims 1 to 10, further comprising: a third indicia on or overlaying the at least one tray visually corresponding to the third compartment, and a fourth indicia on or overlaying the at least one tray visually corresponding to the fourth compartment.

17. The kit of claim 16, wherein the second indicia is positioned on or overlaying the at least one tray between the first and third indicia, and the third indicia is positioned on or overlaying the at least one tray between the second and fourth indicia.

18. The kit of any one of the preceding claims, further comprising:a first symbol on or overlaying the at least one tray, the first symbol corresponding to the first indicia; a second symbol on or overlaying the at least one tray, the second symbol corresponding to the second indicia; a third symbol on or overlaying the at least one tray, the third symbol corresponding to the third indicia; and a fourth symbol on or overlaying the at least one tray, the fourth symbol corresponding to the fourth indicia.

19. The kit of claim 18, further comprising a plurality of arrows on or overlaying the at least one tray, wherein each of the arrows extends between one of the symbols and the corresponding one of the compartments.

20. The kit of any one of claims 2, 3 and 10 to 15, wherein the first compartment and the compartment containing the transfer needle are on a first portion of the at least one tray, the third compartment and the fourth compartment are on a second portion of the at least one tray, and the first portion and the second portion are on opposite sides of the at least one tray.

21. The kit of any one of claims 2, 3 and 10 to 15, wherein the first compartment and the compartment containing the transfer needle are arranged in a parallel orientation.

22. The kit of any one of the preceding claims, wherein a recess in the at least one tray connects the first compartment and the second compartment.

23. The kit of any one of the preceding claims, wherein the third compartment and the fourth compartment are arranged in a parallel orientation.

24. The kit of any one of the preceding claims, wherein a recess in the at least one tray connects the third compartment and the fourth compartment.

25. The kit of any one of the preceding claims, further comprising a warming pack disposed over the at least one tray.

26. The kit of claim 25, wherein the warming pack is disposed over at least a portion of the first compartment.

27. The kit of claim 25 or claim 26, further comprising a booklet disposed over the at least one tray, the booklet including instructions for using the kit.

28. The kit of claim 27, wherein the tray further comprises one or more ribs configured to laterally separate and secure the booklet and the warming pack.

29. The kit of any one of claims 25 to 28, wherein the warming pack includes at least one securement portion configured to secure the warming pack around the pre-filled syringe.

30. The kit of claim 29, wherein the at least one securement portion includes a first portion having a plurality of hook structures and a second portion having a plurality of loop structures.

31. The kit of any one of claims 25 to 30, wherein the warming pack includes an insert configured to activate a solution inside of the warming pack to generate an exothermic reaction.

32. The kit of any one of the preceding claims, wherein the at least one tray is separable from the container.

33. The kit of any one of the preceding claims, wherein the container is a box including an enclosure and a lid, wherein the lid is configured to be opened to access the enclosure.

34. The kit of any one of the preceding claims, further comprising a sheet disposed over the at least one tray, the sheet including a quick reference guide for using the kit.

35. The kit of any one of claims 25 to 31, wherein the container is a box including an enclosure and a lid, wherein the lid is configured to be opened to access the enclosure, wherein the kit further comprising a sheet disposed over the at least one tray, the sheet including a quick reference guide for using the kit, wherein the warming pack and the sheet are positioned between the tray and the lid when the lid is in a closed configuration.

36. The kit of claim 33 or 35, wherein the lid has at least one panel defining a second enclosure, and the second enclosure is received in the first enclosure when the container is closed.

37. The kit of claim 36, wherein the at least one tray includes a first tray and a second tray, the first tray is received in the enclosure, and the second tray is received in the second enclosure.

38. The kit of any one of the preceding claims, wherein at least one of the dosing syringe, the dosing needle, the transfer needle, the vial adapter, and the second transfer needle are each separately enclosed by an individual package.

39. The kit of claim 38, wherein the dosing syringe is in a first package, the dosing needle is in a second package, and each of the first package and the second package have a flat back disposed in a vertical orientation with respect to the at least one tray, wherein the compartments of the tray extend horizontally.

40. The kit of claim 39, wherein the transfer needle is in a third package having a flat back disposed in a horizontal orientation with respect to the at least one tray.

41. The kit of claim 39 or 40, wherein the vial adapter is in a fourth package having a flat back disposed in a horizontal orientation with respect to the at least one tray.

42. The kit of any one of claims 38 to 41, wherein at least one of the packages is a blister pack.

43. The kit of any one of the preceding claims, wherein the vial is individually packaged in a box.

44. The kit of any one of the preceding claims, wherein the first and second indicia are directly printed on the at least one tray.

45. The kit of claim 44, wherein the first and second indicia are inkjet printed on the at least one tray.

46. The kit of claim 44 or 45, wherein the first indicia includes a first area of the at least one tray disposed at least partially around the first compartment, and the second indicia includes a second area of the at least one tray disposed at least partially around the second compartment.

47. The kit of claim 46, wherein the first area is defined by a first color and / or pattern, and the second area is defined by a second color and / or pattern, wherein the second color and / or pattern is different to the first color and / or pattern.

48. The kit of claim 1, wherein the first indicia includes a first area of the at least one tray disposed at least partially around the first compartment, and the second indicia includes a second area of the at least one tray disposed at least partially around the second compartment, wherein the kit further comprises a third indicia on the at least one tray visually corresponding to the third compartment and a fourth indicia on the at least one tray visually corresponding to the fourth compartment, wherein the third indicia includes a third area of the at least one tray disposed at least partially around the third compartment, and the fourth indicia includes a fourth area of the at least one tray disposed at least partially around the fourth compartment,wherein the first, second, third and fourth indicia are directly printed on the at least one tray.

49. The kit of claim 48, wherein the first area is defined by a first color and / or pattern, the second area is defined by a second color and / or pattern, the third area is defined by a third color and / or pattern, the fourth area is defined by a fourth color and / or pattern, wherein the first, second, third and fourth colors and / or patterns are different to each other.

50. The kit of any one of claims 1 to 43, further comprising an insert disposed over the at least one tray, and the first indicia and the second indicia are formed or printed on the insert.

51. The kit of claim 50, wherein the first indicia includes a first area of the insert disposed at least partially around the first compartment, and the second indicia includes a second area of the insert disposed at least partially around the second compartment.

52. The kit of claim 51, wherein the first area is defined by a first color and / or pattern, and the second area is defined by a second color and / or pattern, wherein the second color and / or pattern is different to the first color and / or pattern.

53. The kit of any one of claims 50 to 52, wherein the insert includes one or more openings aligned with the compartments.

54. The kit of any one of claims 50 or claim 53, wherein the insert includes a first opening aligned with the first compartment and a second opening aligned with the third compartment and the fourth compartment.

55. The kit of claim 54, wherein the first opening is further aligned with the compartment including the transfer needle.

56. The kit of any one of claims 50 to 55, wherein the insert includes a third opening aligned with the second compartment.

57. The kit of claim 56, wherein the insert includes a fourth opening aligned with the compartment containing the vial adapter.

58. The kit of any one of the preceding claims, wherein the first indicia includes at least one first ring disposed at least partially around the first compartment, and the second indicia includes at least one second ring disposed at least partially around the second compartment.

59. The kit of claim 58, wherein the at least one first ring is a first color and / or pattern, and the at least one second ring is a second color and / or pattern, wherein the second color and / or pattern is different to the first color and / or pattern.

60. The kit of claim 58 or 59, wherein the at least one first ring includes a ring around the first compartment and the compartment receiving the transfer needle, wherein the at least one second ring includes a ring around the second compartment, wherein the kit further comprises a ring around the compartment receiving the vial adapter and a ring around the third and fourth compartments.

61. The kit of any one of claims 50 to 60, wherein the insert includes: a first partition attached at a first perforation and covering the pre-filled syringe and the vial, a second partition attached at a second perforation and covering the dosing syringe and the dosing needle, and the first partition and the second partition are individually openable.

62. The kit of any one of claims 50 to 61, wherein the insert is in the form of a sleeve that receives the at least one tray.

63. The kit of any one of the preceding claims, wherein the container has a central panel pivotably attached to the container, the central panel having a first central panel indicia formed or disposed around a first portion, the first central panel indicia corresponding to the first indicia, and a second central panel indicia formed or disposed around a second portion, the second central panel indicia corresponding to the second indicia.

64. The kit of any one of the preceding claims, further comprising a tab disposed over at least one of the compartments, wherein the tab is configured to deflect when a user removes a component from the respective compartment.

65. The kit of any one of the preceding claims, wherein the at least one tray includes a first tray portion and a second tray portion, the first compartment and the second compartment are in the first tray portion, the third compartment and the fourth compartment are in the second tray portion, and the first tray portion and the second tray portion are separable.

66. The kit of claim 65, wherein the first tray portion at least partially overlies the second tray portion.

67. The kit of any one of the preceding claims, wherein the at least one tray is a single, unitary tray.

68. The kit of any one of the preceding claims, wherein the dosing needle is covered with a needle sheath and is attached to a safety shield.

69. The kit of any one of the preceding claims, wherein the diluent includes an organic solvent.

70. The kit of claim 69, wherein the organic solvent is dimethyl sulfoxide (DMSO).

71. The kit of any one of the preceding claims, wherein the diluent has a melting point above 8°C.

72. The kit of any one of the preceding claims, wherein the vial contains from 318 mg to 950 mg of olanzapine.

73. The kit of any one of the preceding claims, wherein the pre-fdled syringe contains from 0.73 g to 2.5 g of the diluent.

74. The kit of any one of the preceding claims, wherein diluent comprises: greater than 70 wt% olanzapine; and less than 30 wt% biodegradable polymer excipient.

75. The kit of any one of the preceding claims, wherein diluent comprises: from 73 wt% to 80 wt% olanzapine; and from 20 wt% to 27 wt% biodegradable polymer excipient.

76. The kit of any one of the preceding claims, wherein the kit is for use in the treatment of a psychotic disorder.

77. The kit of claim 76, wherein the kit is for use in the treatment of schizophrenia.

78. A method of preparing a dose of medicament for the treatment of a psychotic disorder, the method comprising: providing the kit of any one of the preceding claims; transferring the diluent from the pre-fdled syringe into the vial to reconstitute the medicament; and transferring a dose of the reconstituted medicament from the vial to the dosing syringe.

79. A method of preparing a dose of medicament for the treatment of a psychotic disorder, the method comprising: providing a kit, wherein the kit comprises: a container; at least one tray disposed in the container; a pre-fdled syringe containing a diluent comprising a biodegradable polymer excipient, the pre-fdled syringe being disposed in a first compartment of the at least one tray; a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof, the vial being disposed in a second compartment of the at least one tray; a dosing syringe configured to administer the medicament, the dosing syringe being disposed in a third compartment of the at least one tray; a dosing needle configured to be attached to the dosing syringe, the dosing needle being disposed in a fourth compartment of the at least one tray; a first indicia on or overlaying the at least one tray visually corresponding to the first compartment; and a second indicia on or overlaying the at least one tray visually corresponding to the second compartment, wherein the second indicia is different than the first indicia, wherein the method further comprises: transferring the diluent from the pre-filled syringe into the vial to reconstitute the medicament; and transferring a dose of the reconstituted medicament from the vial to the dosing syringe.

80. The method of claim 78 or 79, wherein the method is a method of preparing a dose of medicament for the treatment of schizophrenia.

81. A method of treating a patient for psychotic disorder, the method comprising: providing a kit, wherein the kit comprises: a container; at least one tray disposed in the container; a pre-filled syringe containing a diluent comprising a biodegradable polymer excipient, the pre-filled syringe being disposed in a first compartment of the at least one tray; a vial containing a medicament comprising olanzapine or a pharmaceutically acceptable salt thereof, the vial being disposed in a second compartment of the at least one tray; a dosing syringe configured to administer the medicament, the dosing syringe being disposed in a third compartment of the at least one tray; a dosing needle configured to be attached to the dosing syringe, the dosing needle being disposed in a fourth compartment of the at least one tray;a first indicia on or overlaying the at least one tray visually corresponding to the first compartment; and a second indicia on or overlaying the at least one tray visually corresponding to the second compartment, wherein the second indicia is different than the first indicia, wherein the method further comprises: transferring the diluent from the pre-filled syringe into the vial to reconstitute the medicament; transferring a dose of the reconstituted medicament from the vial to the dosing syringe; and administering the dose of the reconstituted medicament from the dosing syringe to a patient.

82. The method of claim 81, wherein the psychotic disorder is schizophrenia.

83. Use of the kit of any one of claims 1 to 77 for the treatment of a psychotic disorder.

84. The use of claim 83, wherein the psychotic disorder is schizophrenia.

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