Oral drug dosage forms for gastric retention.

Abstract

In some aspects, the present disclosure relates to drug dosage forms designed to provide a desired retention in an individual based on the geometric difference between the dosage form's pre-administration state and post-administration state. In certain aspects, oral drug dosage forms are provided that include a swellable and expandable material configured to, upon swelling or expansion, promote expansion of the oral drug dosage form's overall size so that the oral drug dosage form is retained in the stomach for a desired period of time. In certain other aspects, the present disclosure relates to components useful in the oral drug dosage forms taught herein. In certain other aspects, the present disclosure relates to design methods, manufacturing methods including three-dimensional (3D) printing, injection molding, ultrasonic welding, or any combination thereof, commercial batches, and methods of delivering a drug to an individual, including administering the oral drug dosage forms taught herein.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of PCT / CN2022 / 125982, filed October 18, 2022, which is incorporated herein by reference in its entirety. [Technical Field]

[0002] In some aspects, the present disclosure relates to drug dosage forms designed to provide a desired retention in an individual based on the geometric difference between the dosage form's pre-administration state and post-administration state. In certain aspects, oral drug dosage forms are provided that include a swellable and expandable material configured to, upon swelling or expansion, promote expansion of the oral drug dosage form's overall size so that the oral drug dosage form is retained in the stomach for a desired period of time. In certain other aspects, the present disclosure relates to components useful in the oral drug dosage forms taught herein. In certain other aspects, the present disclosure relates to design methods, manufacturing methods including three-dimensional (3D) printing, injection molding, ultrasonic welding, or any combination thereof, commercial batches, and methods of delivering a drug to an individual, including administering the oral drug dosage forms taught herein. [Background technology]

[0003] When administered to an individual, a conventional oral drug dosage form is subject to natural forces, such as the natural flow of fluids, semi-solids, and solids through the individual's gastrointestinal system, and / or forces exerted by the individual, such as muscle contractions, or gravity, in the individual's environment. As with oral administration, this natural flow can vary between administrations of a drug dosage form to a particular individual and across a population of individuals, based on the variable circumstances relative to when the drug dosage form was administered, such as the timing and size of meals and / or beverages, the contents of meals and / or beverages, and the current gastric phase and duration of the remainder. These circumstances result in variability in, for example, the anatomical location of drug delivery, bioavailability, safety profile, and effectiveness of drug dosage forms with gastric retention periods, such as oral drug dosage forms. Summary of the Invention

[0004] In certain aspects, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising a swellable material; a movable arm configured such that at least a portion of the movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the swellable material, the body comprising a swellable material section configured to contain at least a portion of the swellable material; and a directional channel and / or orifice operatively connected to the swellable material section, the movable arm extending beyond or away from a body of the oral drug dosage form via a force provided by the swellable material. the movable arm including the directional channel and / or orifice, the directional channel and / or orifice including a contact element configured to interact with the swellable material or a feature associated with the swellable material, adjacent the orifice, one or more fluid inlets operably connected to the swellable material section; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides the gastric retention, the elongated dosage form in the post-administration state of the oral drug dosage form being due at least in part to the expansion of the swellable material in the presence of gastrointestinal fluid.

[0005] In certain aspects, a drug dosage form or medical device is provided that is stored within a body, the drug dosage form or medical device comprising a swellable material and a movable arm configured to extend beyond or rotate about the body of the drug dosage form or medical device via a force provided by the swellable material, the body comprising a swellable material compartment configured to contain at least a portion of the swellable material, the swellable material compartment operably including one or more fluid inlets, and directional channels and orifices operably connected to the swellable material compartment. The device comprises: a movable arm including a directional channel and an orifice, the movable arm including a contact element configured to interface with the swellable material, or a feature associated with the swellable material, in proximity to the directional channel and the orifice; and a drug; wherein the drug dosage form or medical device is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form providing the retention within the body, the elongated dosage form in the post-administration state of the drug dosage form or medical device being at least partially due to expansion of the swellable material in the presence of bodily fluid.

[0006] In some embodiments, the feature associated with the swellable material comprises a plunger or piston.

[0007] In some embodiments, the movable arm or body includes a pivot, and the movable arm is connected to the body by a pivot.

[0008] In some embodiments, the swellable material section comprises a cap and a base, and the pivot of the movable arm is connected to the cap.

[0009] In some embodiments, the post-administration state of the oral drug dosage form occurs within one hour after administration of the oral drug dosage form to the individual.

[0010] In some embodiments, the gastric retention of the oral drug dosage form is from about 8 hours to about 3 months.

[0011] In some embodiments, the swellable material expands in volume by at least about 1.2 times after exposure to gastrointestinal fluids, hi some embodiments, the swellable material has a volume expansion rate of at least about 1.2 times in 30 minutes.

[0012] In some embodiments, the swellable material, upon swelling, at least partially conforms to the shape of the directional channel and / or the orifice, or a portion thereof, hi some embodiments, the swellable material, upon swelling, assumes a predetermined shape and / or size.

[0013] In some embodiments, the swellable material in the swellable material compartment is in an amount of at least about 5 mg.

[0014] In some embodiments, the swellable material comprises sodium alginate (SA), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), hydroxypropyl methylcellulose (HPMC), polyethylene oxide (PEO), polyvinyl alcohol (PVA), microcrystalline cellulose (MCC), croscarmellose sodium (CCNa), carboxymethyl cellulose sodium (CMC-Na), polyvinylpolypyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), polyethylene glycol (PEG), or a mixture thereof. In some embodiments, the swellable material further comprises a salt or a mixture of salts. In some embodiments, the salt is selected from the group consisting of sodium salts, magnesium salts, and potassium salts.

[0015] In some embodiments, the swellable material is about 10 mm 3 ~approx. 50mm 3 has a swelling volume of

[0016] In some embodiments, the body comprises two or more parts configured to form the body. In some embodiments, the body comprises one or more bases and one or more caps. In some embodiments, the body comprises two or more materials. In some embodiments, the body of the oral drug dosage form is a monolithic structure.

[0017] In some embodiments, the body delineates the outer boundary of the oral drug dosage form in a pre-administered state.

[0018] In some embodiments, the oral drug dosage form in a pre-dosed state has a maximum transverse dimension of 24 mm or less. In some embodiments, at least two vertical dimensions of the oral drug dosage form in a post-dosed state are 20 mm or greater.

[0019] In some embodiments, the swellable material section is configured to substantially contain the swellable material in a pre-administration state, hi some embodiments, the swellable material section and the contact element of the movable arm substantially surround the swellable material.

[0020] In some embodiments, the directional channel is configured to direct movement of the movable arm through the swellable material. In some embodiments, the directional channel comprises a curved channel. In some embodiments, the directional channel comprises a circular channel. In some embodiments, the directional channel comprises a square or rectangular channel. In some embodiments, the directional channel comprises a linear channel, an oval channel, or a capsule-shaped channel.

[0021] In some embodiments, the orifice is square or rectangular.

[0022] In some embodiments, the directional channel further comprises one or more fluid inlets. In some embodiments, at least one of the one or more fluid inlets comprises a semi-permeable material. In some embodiments, the at least one of the one or more fluid inlets is the semi-permeable material filling a pore formed by the body. In some embodiments, the one or more fluid inlets is a semi-permeable membrane at least partially wrapped around the swellable material. In some embodiments, at least one of the one or more fluid inlets is a pore.

[0023] In some embodiments, the body further defines a stop configured to engage the movable arm in an extended position, hi some embodiments, the stop includes a locking element configured to maintain the movable arm in one or more extended positions.

[0024] In some embodiments, the movable arm, or a portion thereof, is configured to slide within the directional channel. In some embodiments, the contact element of the movable arm is configured to slide within the directional channel. In some embodiments, the movable arm is configured to rotate on an axis.

[0025] In some embodiments, the oral drug dosage form further comprises one or more movable arms. In some embodiments, at least two of the movable arms have different movement mechanisms. In some embodiments, at least two of the movable arms have the same movement mechanism. In some embodiments, at least two of the movable arms are configured such that at least a portion of each of the movable arms is extendable beyond or beyond the body of the oral drug dosage form via a force provided by the swellable material.

[0026] In some embodiments, the oral drug dosage form further comprises a second swellable material at least partially contained within a second swellable material compartment formed by the body, and at least one of the movable arms is configured such that at least a portion of the movable arm is extendable beyond or further away from the body of the oral drug dosage form via a force provided by the second swellable material.

[0027] In some embodiments, the oral drug dosage form further comprises an erodible restraint configured to prevent extension of the movable arm, hi some embodiments, the erodible restraint erodes within about 30 minutes after administration to an individual.

[0028] In some embodiments, the drug is located within one or more of the movable arm and the body, hi some embodiments, the drug is selected from the group consisting of ribonuclease, aceclofenac, bicalutamide, carbamazepine, carvedilol, clotrimazole, cinnarizine, danazol, dapsone, estradiol, ethiofen, glibenclamide, fenofibrate, griseofulvin, ibuprofen, itraconazole, ketoconazole, mefenamic acid, naproxen, nevirapine, nifedipine, nitrofurantoin, nomegestrol acetate, phenytoin sodium, piroxicam, praziquantel, rifampicin, sulfamethoxazole, trimethoprim, and verapamil hydrochloride.

[0029] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising a swellable material; a movable arm configured such that at least a portion of the movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the swellable material, the body comprising a swellable material section configured to contain at least a portion of the swellable material; and a directional channel operatively connected to the swellable material section, the movable arm including a contact element configured to interact with the swellable material proximate the directional channel, the swellable material section and the contact element of the movable arm substantially surrounding the swellable material, a directional channel, wherein a movable arm or a portion thereof is configured to slide within the directional channel such that the movable arm extends beyond or further from the body of the oral drug dosage form along an axis based on the directional channel; one or more fluid inlets operably connected to the swellable material section; and a stop configured to engage the movable arm in an extended position; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides the gastric retention, the elongated dosage form in the post-administration state of the oral drug dosage form being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid. In some embodiments, the stop includes a locking element configured to maintain the movable arm in one or more extended positions. In some embodiments, the locking element is configured to maintain the movable arm in a single position. In some embodiments, the locking element is configured to maintain the movable arm in a plurality of advanced positions.

[0030] In another aspect, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising a swellable material and a first movable arm and a second movable arm, the first movable arm and the second movable arm configured such that at least a portion of each movable arm is extendable beyond or away from a body of the oral drug dosage form through a force provided by the swellable material, the first movable arm and the second movable arm extend in substantially opposite directions along an axis based on the directional channel, and the body is configured to extend .... a swellable material section configured to contain at least a portion of a wettable material; and a first directional channel and a second directional channel operatively connected to the swellable material section, wherein the first movable arm includes a first contact element configured to interact with the swellable material in proximity to the first directional channel, and the second movable arm includes a second contact element configured to interact with the swellable material in proximity to the second directional channel, the swellable material section and the first contact element of the first movable arm and the second contact element of the second movable arm substantially surround the swellable material, the first movable arm or a portion thereof is configured to slide within the first directional channel such that the first movable arm extends beyond or further away from the body of the oral drug dosage form along the axis, and the second movable arm or a portion thereof is configured to slide within the second directional channel such that the second movable arm extends beyond or further away from the body of the oral drug dosage form along the axis. a first movable arm and a second movable arm, the first movable arm including a first channel and a second directional channel, one or more fluid inlets operatively connected to the swellable material section, a first stop configured to engage with the first movable arm in an extended position, and a second stop configured to engage with the second movable arm in an extended position; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an extended dosage form providing the gastric retention, the extended dosage form in the post-administration state of the oral drug dosage form beingThis is at least partially due to the expansion of the swellable material in the presence of gastrointestinal fluids.

[0031] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising a first swellable material; a first movable arm, the first movable arm configured such that at least a portion of the movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the first swellable material, the first movable arm configured to rotate on a first axis; a second swellable material; and a second movable arm, the second movable arm configured to and a first directional channel operatively connected to the first swellable material section, the first directional channel comprising a curved channel, the first movable arm configured to rotate on a second axis, the first swellable material section configured to contain at least a portion of the first swellable material, the first directional channel operatively connected to the first swellable material section, the first directional channel comprising a curved channel, and the first movable arm configured to rotate on a second axis, the first swellable material section configured to contain at least a portion of the first swellable material, the first directional channel operatively connected to the first swellable material section ... a first contact element configured to interact with the first swellable material adjacent to a first directional channel, wherein the first contact element of the first swellable material section and the first movable arm substantially surrounds the first swellable material, and the first movable arm, or a portion thereof, is configured to rotate on the first axis in such a manner that the first contact element slides within the first directional channel such that the first movable arm extends beyond or away from the body of the oral drug dosage form. a second swellable material section configured to contain at least a portion of the second swellable material; a second directional channel operatively connected to the second swellable material section, the second directional channel comprising a curved channel; the second movable arm comprising a second contact element configured to interact with the second swellable material proximate the second directional channel, the second swellable material section and the second contact element of the second movable arm substantially surrounding the second swellable material;the second movable arm, or a portion thereof, including a second directional channel configured to rotate on the second axis in a manner such that the second contact element slides within the second directional channel such that the second movable arm extends beyond or further away from the body of the oral drug dosage form; and one or more fluid inlets operatively connected to the second swellable material section; and a drug, wherein the oral drug dosage form is configured to have a pre-dosage state having a compact dosage form and a post-dosage state having an elongated dosage form that provides the gastric retention, the elongated dosage form in the post-dosage state of the oral drug dosage form being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid.

[0032] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising a first swellable material and a first movable arm and a second movable arm, the first movable arm and the second movable arm configured such that at least a portion of each movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the first swellable material, the first movable arm and the second movable arm being oriented in substantially opposite directions along an axis based on the directional channel. a third movable arm configured such that at least a portion of the third movable arm is extendable beyond or further away from the body of the oral drug dosage form through a force provided by the second swellable material, the third movable arm configured to rotate on a first axis, a third swellable material, and a fourth movable arm configured such that at least a portion of the fourth movable arm is extendable beyond or further away from the body of the oral drug dosage form through a force provided by the second swellable material, the third movable arm being configured to rotate on a first axis, a third swellable material, and a fourth movable arm configured such that at least a portion of the fourth movable arm is extendable beyond or further away from the body of the oral drug dosage form through a force provided by the second swellable material, the third movable arm being extendable and a fourth movable arm configured to rotate on a second axis, the body including a first swellable material section configured to contain at least a portion of the first swellable material, the fourth movable arm being configured to extend beyond or further away from the body of the oral drug dosage form via a force provided by the third swellable material, the fourth movable arm being configured to rotate on a second axis, the body including a first swellable material section configured to contain at least a portion of the first swellable material, a first directional channel and a second directional channel operably connected to the first swellable material section, the first ... proximate the first directional channel and the second directional channel the second movable arm includes a first contact element configured to interact with the first swellable material proximate the second directional channel, the first swellable material section and the first contact element of the first movable arm and the second contact element of the second movable arm substantially surround the first swellable material, and the first movable arm, or a portion thereof, extends beyond or away from the body of the oral drug dosage form along the axis such that the first movable arm extends beyond or away from the body of the oral drug dosage form along the axis;the first directional channel and a second directional channel configured to slide within the first directional channel, and the second movable arm, or a portion thereof, configured to slide within the second directional channel such that the second movable arm extends beyond or further away from the body of the oral drug dosage form along the axis; one or more fluid inlets operably connected to the first swellable material section; a first stop configured to engage the first movable arm in an extended position; a second swellable material section configured to contain at least a portion of the second swellable material; a third directional channel operatively connected to the second swellable material section, the third directional channel comprising a curved channel; the third movable arm comprising a contact element configured to interact with the second swellable material proximate the third directional channel, the contact element of the second swellable material section and the third movable arm substantially surrounding the second swellable material; a third directional channel, a portion of which is configured to rotate on the first axis in a manner such that the contact element slides within the third directional channel such that the third movable arm extends beyond or further from the body of the oral drug dosage form; one or more fluid inlets operatively connected to the third swellable material section; a third swellable material section configured to contain at least a portion of the third swellable material; and a fourth directional channel operatively connected to the third swellable material section, wherein the fourth directional channel the fourth movable arm includes a curved channel, the fourth movable arm includes a contact element configured to interact with the third swellable material proximate the fourth directional channel, the third swellable material section and the contact element of the fourth movable arm substantially surround the third swellable material, and the fourth movable arm, or a portion thereof, is configured to rotate on the second axis in a manner such that the contact element slides within the fourth directional channel such that the fourth movable arm extends beyond or further away from the body of the oral drug dosage form.the fourth movable arm including the fourth directional channel and one or more fluid inlets operatively connected to the third swellable material section; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides the gastric retention, the elongated dosage form in the post-administration state of the oral drug dosage form being due at least in part to expansion of the first swellable material, the second swellable material, and the third swellable material in the presence of gastrointestinal fluid.

[0033] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising a swellable material and a first movable arm and a second movable arm, the first movable arm and the second movable arm configured such that at least a portion of each movable arm is extendable beyond or away from a body of the oral drug dosage form through a force provided by the swellable material, the first movable arm and the second movable arm configured to rotate in opposite directions on a shared axis, the body being configured to rotate in opposite directions to the swellable material. a swellable material section configured to contain at least a portion of a wettable material; and a first directional channel and a second directional channel operatively connected to the swellable material section, the first directional channel and the second directional channel being curved and configured about the shared axis, the first movable arm including a first contact element configured to interact with the swellable material proximate the first directional channel, the first contact element being ladder-shaped, and the first movable arm being configured to move the oral drug dosage form relative to the shared axis. the first and second directional channels configured to move within the first directional channel to rotate beyond or further away from the body, the second movable arm including a second contact element configured to interact with the swellable material in proximity to the second directional channel, the second contact element being ladder-shaped and configured to move within the second directional channel to rotate beyond or further away from the body of the oral drug dosage form relative to the shared axis; one or more fluid inlets operably connected to the swellable material section; and stops configured to engage the first and second movable arms in an extended position; and a drug; wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form providing the gastric retention, the elongated dosage form in the post-administration state of the oral drug dosage form being due at least in part to the expansion of the swellable material in the presence of gastrointestinal fluid.In some embodiments, the stop is configured to engage the first contact element of the first movable arm and the second contact element of the second movable arm in the extended position.

[0034] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising: a swellable material; a first movable arm, a second movable arm, a third movable arm, and a fourth movable arm, wherein the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the swellable material; a body, a swellable material compartment configured to contain at least a portion of the swellable material; and a directional channel and / or orifice operably connected to the swellable material compartment, wherein each movable arm is proximate to the directional channel and / or the orifice and interacts with the swellable material. the directional channels and / or orifices including contact elements configured to interact with each other, wherein the swellable material section, the contact elements of the movable arms, and a cap substantially surround the swellable material; the body including one or more fluid inlets operably connected to the swellable material section; a cap; and first, second, third, and fourth stops configured to engage with the first, second, third, and fourth movable arms, respectively, in an extended position; and a drug; wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention, and the elongated dosage form in the post-administration state of the oral drug dosage form is due at least in part to the expansion of the swellable material in the presence of gastrointestinal fluid.

[0035] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising: a swellable material; a first movable arm, a second movable arm, a third movable arm, and a fourth movable arm, wherein the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the swellable material; a body, a swellable material compartment configured to contain at least a portion of the swellable material; and a directional channel and / or orifice operatively connected to the swellable material compartment, wherein each movable arm is proximate to the directional channel and / or the orifice to move the swellable material. the directional channel and / or orifice including a contact element configured to interact with a swellable material, wherein the contact elements of the swellable material section and the movable arms substantially surround the swellable material, the body including one or more fluid inlets operably connected to the swellable material section, and first, second, third, and fourth stops configured to engage the first, second, third, and fourth movable arms, respectively, in an extended position, and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an extended dosage form providing the gastric retention, the extended dosage form of the oral drug dosage form in the post-administration state being due at least in part to the expansion of the swellable material in the presence of gastrointestinal fluid. In some embodiments, the oral drug dosage form further includes an erodible restraint configured to prevent extension of the movable arms.

[0036] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising: a swellable material at least partially encased in a semipermeable membrane; a first movable arm, a second movable arm, a third movable arm, and a fourth movable arm, wherein the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the swellable material; and a body having a first connection point for the first arm, a second connection point for the second arm, a third connection point for the third arm, and a fourth connection point for the fourth arm, wherein each connection point is connected to the first arm, the second arm, the third arm, and the fourth arm. and a body including: a first connection point, a second connection point, a third connection point, and a fourth connection point configured to provide the independent axis for rotation of the fourth arm, each movable arm including a contact element configured to interact with the swellable material or the semi-permeable material; and a first stop, a second stop, a third stop, and a fourth stop configured to engage the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm, respectively, in an extended position, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form providing the gastric retention, the elongated dosage form of the oral drug dosage form in the post-administration state being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid. In some embodiments, the body does not include a swellable material section. In some embodiments, the swellable material is positioned on the body such that expansion of the swellable material actuates the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm to an extended position.

[0037] In another aspect, provided herein is a swellable structure for use in an oral drug dosage form, the swellable structure comprising: a swellable material; an outer shell comprising at least two layers, the at least two layers having successively smaller outer dimensions, the at least two layers configured to have a pre-administration state having a compact dosage form; at least two of the at least two layers sliding along an axis, the at least two layers configured to have a post-administration state having an expanded dosage form, the at least two layers expanding along the axis, the post-administration state having the expanded dosage form providing the gastric retention; and one or more fluid inlets operably connected to the swellable material compartment, wherein the swellable structure is at least partially due to expansion of the swellable material in the presence of gastrointestinal fluid. In some embodiments, the at least two layers of the outer shell are coaxial. In some embodiments, the at least two layers of the outer shell are concentric.

[0038] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising an expandable material; a first movable arm, a second movable arm, a third movable arm, and a fourth movable arm, wherein the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the expandable material; a body, an expandable material section configured to contain at least a portion of the expandable material; and a directional channel and / or orifice operably connected to the expandable material section, wherein each movable arm is configured to rotate on an independent axis toward a vertical plane via a force provided by the expandable material; the body including a directional channel and / or orifice, the directional channel and / or orifice including a contact element configured to interact with the expandable material adjacent to the orifice, the expandable material section, the contact element of the movable arm, and a cap substantially surrounding the expandable material; and first, second, third, and fourth stops configured to engage with the first, second, third, and fourth movable arms, respectively, in an extended position; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an extended dosage form providing the gastric retention, the extended dosage form of the oral drug dosage form in the post-administration state being due at least in part to the expansion of the expandable material in the presence of gastrointestinal fluid.

[0039] All references cited herein, including patent applications and publications, are hereby incorporated by reference in their entirety.

[0040] Those skilled in the art will also understand that changes in form and detail of the implementations described herein may be made without departing from the scope of the present disclosure. Additionally, while various advantages, aspects, and objectives have been described with reference to various implementations, the scope of the present disclosure should not be limited with reference to such advantages, aspects, and objectives. [Brief explanation of the drawings]

[0041] [Figure 1A] A diagram of an example drug dosage form 100 is shown that includes a swellable material 102 and a movable arm 108 . [Figure 1B] A diagram of an example drug dosage form 100 is shown that includes a swellable material 102 and a movable arm 108 . [Figure 1C] Component views and a schematic diagram of a drug dosage form 100 are shown. [Figure 1D] Component views and a schematic diagram of a drug dosage form 100 are shown. [Figure 2A] A diagram of an example drug dosage form 200 is shown, which includes a swellable material 202 and a movable arm 208. [Figure 2B] A diagram of an example drug dosage form 200 is shown, which includes a swellable material 202 and a movable arm 208. [Figure 2C] Component views and a schematic diagram of a drug dosage form 200 are shown. [Figure 2D] Component views and a schematic diagram of a drug dosage form 200 are shown. [Figure 2E] A diagram of an example drug dosage form 250 is shown. [Figure 2F] A diagram of an example drug dosage form 250 is shown. [Figure 2G] Component views and a schematic diagram of a drug dosage form 250 are shown. [Figure 3A] A diagram of an example drug dosage form 300 is shown that includes a swellable material 302 and a movable arm 308 . [Figure 3B] A diagram of an example drug dosage form 300 is shown that includes a swellable material 302 and a movable arm 308 . [Figure 3C] A schematic diagram of a component view is shown. [Figure 4A] A diagram of an example drug dosage form 400 is shown that includes a swellable material 402 and two of the illustrated movable arms 408, 418. [Figure 4B]A diagram of an example drug dosage form 400 is shown that includes a swellable material 402 and two of the illustrated movable arms 408, 418. [Figure 4C] 4 shows a component view and a schematic diagram of a drug dosage form 400. [Figure 4D] 4 shows a component view and a schematic diagram of a drug dosage form 400. [Figure 5A] A diagram of an example drug dosage form 500 is shown that includes two movable arms 508, 520, each having a respective swellable material and swellable material section. [Figure 5B] A diagram of an example drug dosage form 500 is shown that includes two movable arms 508, 520, each having a respective swellable material and swellable material section. [Figure 5C] A diagram of an example drug dosage form 500 is shown that includes two movable arms 508, 520, each having a respective swellable material and swellable material section. [Figure 5D] A diagram of an example drug dosage form 500 is shown that includes two movable arms 508, 520, each having a respective swellable material and swellable material section. [Figure 5E] 5 shows a component view and a schematic diagram of a drug dosage form 500. [Figure 5F] 5 shows a component view and a schematic diagram of a drug dosage form 500. [Figure 6A] A diagram of an example drug dosage form 600 is shown that includes four moveable arms 614, 616, 630, 632. [Figure 6B] A diagram of an example drug dosage form 600 is shown that includes four moveable arms 614, 616, 630, 632. [Figure 6C] A diagram of an example drug dosage form 600 is shown that includes four moveable arms 614, 616, 630, 632. [Figure 6D] A diagram of an example drug dosage form 600 is shown that includes four moveable arms 614, 616, 630, 632. [Figure 6E] 6 shows a component view and a schematic diagram of a drug dosage form 600. [Figure 6F]6 shows a component view and a schematic diagram of a drug dosage form 600. [Figure 6G] 6 shows a component view and a schematic diagram of a drug dosage form 600. [Figure 6H] 6 shows a component view and a schematic diagram of a drug dosage form 600. [Figure 7A] A diagram of an example drug dosage form 700 is shown that includes two movable arms 704, 706 that rotate on an axis 730. [Figure 7B] A diagram of an example drug dosage form 700 is shown that includes two movable arms 704, 706 that rotate on an axis 730. [Figure 7C] A diagram of an example drug dosage form 700 is shown that includes two movable arms 704, 706 that rotate on an axis 730. [Figure 7D] A diagram of an example drug dosage form 700 is shown that includes two movable arms 704, 706 that rotate on an axis 730. [Figure 7E] A diagram of an example drug dosage form 700 is shown that includes two movable arms 704, 706 that rotate on an axis 730. [Figure 7F] A diagram of an example drug dosage form 700 is shown that includes two movable arms 704, 706 that rotate on an axis 730. [Figure 7G] 7 shows a component view and a schematic diagram of a drug dosage form 700. [Figure 7H] 7 shows a component view and a schematic diagram of a drug dosage form 700. [Figure 7I] 7 shows a component view and a schematic diagram of a drug dosage form 700. [Figure 8A] A diagram of an example drug dosage form 800 is shown that includes four movable arms 814, 816, 818, 820 that each rotate on an axis, eg, 824. [Figure 8B] A diagram of an example drug dosage form 800 is shown that includes four movable arms 814, 816, 818, 820 that each rotate on an axis, eg, 824. [Figure 8C] A diagram of an example drug dosage form 800 is shown that includes four movable arms 814, 816, 818, 820 that each rotate on an axis, eg, 824. [Figure 8D] A diagram of an example drug dosage form 800 is shown that includes four movable arms 814, 816, 818, 820 that each rotate on an axis, eg, 824. [Figure 8E] 8 shows a component view and a schematic diagram of a drug dosage form 800. [Figure 8F] 8 shows a component view and a schematic diagram of a drug dosage form 800. [Figure 8G] 8 shows a component view and a schematic diagram of a drug dosage form 800. [Figure 8H] 8 shows a component view and a schematic diagram of a drug dosage form 800. [Figure 8I] 8 shows a component view and a schematic diagram of a drug dosage form 800. [Figure 9A] A diagram of an example drug dosage form 900 is shown that includes four movable arms 914, 916, 918, 920 that each rotate on an axis, eg, 924. [Figure 9B] A diagram of an example drug dosage form 900 is shown that includes four movable arms 914, 916, 918, 920 that each rotate on an axis, eg, 924. [Figure 9C] A diagram of an example drug dosage form 900 is shown that includes four movable arms 914, 916, 918, 920 that each rotate on an axis, eg, 924. [Figure 9D] A diagram of an example drug dosage form 900 is shown that includes four movable arms 914, 916, 918, 920 that each rotate on an axis, eg, 924. [Figure 9E] 9 shows a component view and a schematic diagram of a drug dosage form 900. [Figure 9F] 9 shows a component view and a schematic diagram of a drug dosage form 900. [Figure 9G] 9 shows a component view and a schematic diagram of a drug dosage form 900. [Figure 9H] 9 shows a component view and a schematic diagram of a drug dosage form 900. [Figure 9I] 9 shows a component view and a schematic diagram of a drug dosage form 900. [Figure 10A] A diagram of an example drug dosage form 1000 is shown that includes four movable arms 1014, 1016, 1018, 1020 that rotate on an axis, eg, 1024. [Figure 10B] A diagram of an example drug dosage form 1000 is shown that includes four movable arms 1014, 1016, 1018, 1020 that rotate on an axis, eg, 1024. [Figure 10C] A diagram of an example drug dosage form 1000 is shown that includes four movable arms 1014, 1016, 1018, 1020 that rotate on an axis, eg, 1024. [Figure 10D] A diagram of an example drug dosage form 1000 is shown that includes four movable arms 1014, 1016, 1018, 1020 that rotate on an axis, eg, 1024. [Figure 10E] 1 shows a component view and a schematic diagram of a drug dosage form 1000. [Figure 10F] 1 shows a component view and a schematic diagram of a drug dosage form 1000. [Figure 11A] A diagram of an example drug dosage form 1100 is shown that includes four movable arms 1114, 1116, 1118, 1120 that each rotate on an axis, eg, 1124. [Figure 11B] A diagram of an example drug dosage form 1100 is shown that includes four movable arms 1114, 1116, 1118, 1120 that each rotate on an axis, eg, 1124. [Figure 11C] A diagram of an example drug dosage form 1100 is shown that includes four movable arms 1114, 1116, 1118, 1120 that each rotate on an axis, eg, 1124. [Figure 11D] 1 shows a component view and a schematic diagram of a drug dosage form 1000. [Figure 11E] 1 shows a component view and a schematic diagram of a drug dosage form 1000. [Figure 12A] 12 shows an example diagram of a swelling structure 1200 that includes four layers 1206, 1208, 1210, and 1212 that expand in a post-administration state due to the expansion of a swellable material 1202. [Figure 12B]12 shows an example diagram of a swelling structure 1200 that includes four layers 1206, 1208, 1210, and 1212 that expand in a post-administration state due to the expansion of a swellable material 1202. [Figure 12C] 12 shows an example diagram of a swelling structure 1200 that includes four layers 1206, 1208, 1210, and 1212 that expand in a post-administration state due to the expansion of a swellable material 1202. [Figure 12D] 12 shows an example diagram of a swelling structure 1200 that includes four layers 1206, 1208, 1210, and 1212 that expand in a post-administration state due to the expansion of a swellable material 1202. [Figure 12E] 12 shows an example diagram of a swelling structure 1200 that includes four layers 1206, 1208, 1210, and 1212 that expand in a post-administration state due to the expansion of a swellable material 1202. [Figure 12F] 12 shows an example diagram of a swelling structure 1200 that includes four layers 1206, 1208, 1210, and 1212 that expand in a post-administration state due to the expansion of a swellable material 1202. [Figure 13A] 13 shows an example diagram of a swelling structure 1300 that includes four layers 1306, 1308, 1310, and 1312 that expand in a post-administration state due to the expansion of a swellable material 1302. [Figure 13B] 13 shows an example diagram of a swelling structure 1300 that includes four layers 1306, 1308, 1310, and 1312 that expand in a post-administration state due to the expansion of a swellable material 1302. [Figure 13C] 13 shows an example diagram of a swelling structure 1300 that includes four layers 1306, 1308, 1310, and 1312 that expand in a post-administration state due to the expansion of a swellable material 1302. [Figure 13D] 13 shows an example diagram of a swelling structure 1300 that includes four layers 1306, 1308, 1310, and 1312 that expand in a post-administration state due to the expansion of a swellable material 1302. [Figure 13E] 13 shows an example diagram of a swelling structure 1300 that includes four layers 1306, 1308, 1310, and 1312 that expand in a post-administration state due to the expansion of a swellable material 1302. [Figure 13F]13 shows an example diagram of a swelling structure 1300 that includes four layers 1306, 1308, 1310, and 1312 that expand in a post-administration state due to the expansion of a swellable material 1302. [Figure 14A] A diagram of an example drug dosage form 1400 is shown, which includes a swellable material 1410, a column 1412, and four moveable arms. [Figure 14B] A diagram of an example drug dosage form 1400 is shown, which includes a swellable material 1410, a column 1412, and four moveable arms. [Figure 15A] A diagram of an example drug dosage form 1500 is shown having two pairs of two movable arms that rotate on a shared axis (first movable arm 1504 and third movable arm 1516 rotate on a first axis 1512, and second movable arm 1506 and fourth movable arm 1518 rotate on a second axis 1514). [Figure 15B] A diagram of an example drug dosage form 1500 is shown having two pairs of two movable arms that rotate on a shared axis (first movable arm 1504 and third movable arm 1516 rotate on a first axis 1512, and second movable arm 1506 and fourth movable arm 1518 rotate on a second axis 1514). [Figure 15C] A diagram of an example drug dosage form 1500 is shown having two pairs of two movable arms that rotate on a shared axis (first movable arm 1504 and third movable arm 1516 rotate on a first axis 1512, and second movable arm 1506 and fourth movable arm 1518 rotate on a second axis 1514). [Figure 15D] 15 shows a component view of a drug dosage form 1500. [Figure 16] 1 shows a picture of a model of an oral drug dosage form after expansion of the swellable material. [Figure 17] 1 shows a picture of a partial model of an oral drug dosage form after expansion of the swellable material. [Figure 18] 1 shows a picture of a replica model of an oral drug dosage form and measurements of the expansion of the movable arm. [Figure 19A] 1 shows an X-ray image of an oral drug dosage form after administration and in vivo status information of the oral drug dosage form. [Figure 19B] 1 shows an X-ray image of an oral drug dosage form after administration and in vivo status information of the oral drug dosage form. [Figure 20A] 1 shows an X-ray image of an oral drug dosage form after administration and in vivo status information of the oral drug dosage form. [Figure 20B] 1 shows an X-ray image of an oral drug dosage form after administration and in vivo status information of the oral drug dosage form. [Figure 21A] A diagram of an example drug dosage form 2100 is shown that includes four movable arms 2114, 2116, 2118, 2120 that rotate on an axis, eg, 2124. [Figure 21B] A diagram of an example drug dosage form 2100 is shown that includes four movable arms 2114, 2116, 2118, 2120 that rotate on an axis, eg, 2124. [Figure 21C] A diagram of an example drug dosage form 2100 is shown that includes four movable arms 2114, 2116, 2118, 2120 that rotate on an axis, eg, 2124. [Figure 22A] A diagram of an example drug dosage form 2200 is shown that includes two movable arms 2214, 2216 that each rotate on an axis, eg, 2226. [Figure 22B] A diagram of an example drug dosage form 2200 is shown that includes two movable arms 2214, 2216 that each rotate on an axis, eg, 2226. [Figure 23A] 1 shows in vitro conditions before and after administration of a drug dosage form. [Figure 23B] 1 shows in vitro conditions before and after administration of a drug dosage form. [Figure 24] We provide information obtained from gastroscopy in beagle dogs administered specific oral drug dosage forms. [Figure 25] 1 provides results from occult blood testing in beagle dogs administered certain oral drug dosage forms. [Figure 26] Remnants of a particular oral drug dosage form collected from the feces of beagles administered the particular oral drug dosage form are provided. DETAILED DESCRIPTION OF THE INVENTION

[0042] In some embodiments, provided herein are oral drug dosage forms comprising a swellable material configured to, upon swelling, promote an expansion in the overall size of the oral drug dosage form so that the oral drug dosage form is retained in the stomach for a desired period of time. The oral drug dosage forms provided herein are based, at least in part, on the inventors' unique perspectives and observations regarding the design and mechanism of oral drug dosage forms that provide oral drug dosage forms small enough for convenient patient administration and have a sufficient size increase in the stomach to inhibit passage through the pylorus for a desired period of time (i.e., the oral drug dosage form retains in the stomach for an extended period of time, e.g., from 8 hours to 3 months). In certain embodiments, the oral drug dosage forms of the present application include one or more movable arms actuated by the swelling of the swellable material, and after increasing in size, the oral drug dosage form maintains sufficient mechanical stability to allow for prolonged gastric retention without interfering with normal gastric function. The drug dosage forms of the present application can also be configured to release drugs according to any desired drug release profile of one or more drugs (e.g., an immediate release profile, a sustained release profile, a delayed sustained release profile, a pulsatile release profile, or any combination thereof).

[0043] Thus, in some aspects, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising: a swellable material; a movable arm configured such that at least a portion of the movable arm is extendable beyond or away from a body of the oral drug dosage form via force provided by the swellable material, the body comprising: a swellable material section configured to contain at least a portion of the swellable material; a directional channel and / or orifice operably connected to the swellable material section, the directional channel and / or orifice comprising a contact element configured to interact with the swellable material or a feature associated with the swellable material proximate the directional channel and / or orifice; one or more fluid inlets operably connected to the swellable material section; and a drug; wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention, the elongated dosage form of the oral drug dosage form in the post-administration state being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluids.

[0044] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising: a swellable material; a movable arm configured such that at least a portion of the movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the swellable material; the body comprising a swellable material section configured to contain at least a portion of the swellable material; and a directional channel operatively connected to the swellable material section, the movable arm including a contact element configured to interact with the swellable material proximate the directional channel, the swellable material section and the contact element of the movable arm substantially surrounding the swellable material; a directional channel, wherein the movable arm or a portion thereof is configured to slide within the directional channel such that the movable arm extends beyond or further away from the body of the oral drug dosage form along an axis based on the directional channel; a movable arm including one or more fluid inlets operably connected to the swellable material section; and a stop configured to engage the movable arm in an extended position; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an extended dosage form that provides gastric retention, the extended dosage form of the oral drug dosage form in the post-administration state being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid.

[0045] In another aspect, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising a swellable material and first and second movable arms, the first and second movable arms configured such that at least a portion of each movable arm is extendable beyond or away from a body of the oral drug dosage form through a force provided by the swellable material, the first and second movable arms extend in substantially opposite directions along an axis based on a directional channel, and the body is configured such that at least a portion of the swellable material is extendable beyond or away from a body of the oral drug dosage form through a force provided by the swellable material. a first directional channel and a second directional channel operatively connected to the swellable material section, the first movable arm including a first contact element configured to interact with the swellable material proximate to the first directional channel, the second movable arm including a second contact element configured to interact with the swellable material proximate to the second directional channel, the swellable material section and the first contact element of the first movable arm and the second contact element of the second movable arm substantially encircle the swellable material, the first movable arm or a portion thereof configured to slide within the first directional channel such that the first movable arm extends beyond or further away from the body of the oral drug dosage form along an axis, and the second movable arm or a portion thereof configured to slide within the second directional channel such that the second movable arm extends beyond or further away from the body of the oral drug dosage form along an axis. the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention, the elongated dosage form of the oral drug dosage form in the post-administration state being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluids; a first movable arm and a second movable arm, the first movable arm and the second movable arm including one or more fluid inlets connected thereto; a first stop configured to engage with the first movable arm in an extended position; and a second stop configured to engage with the second movable arm in an extended position; and a drug.

[0046] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising: a first swellable material; a first movable arm, the first movable arm configured such that at least a portion of the movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the first swellable material, the first movable arm configured to rotate on a first axis; a second swellable material; and a second movable arm, the second movable arm configured such that at least a portion of the movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the first swellable material. and a second movable arm configured to rotate on a second axis, the body including a first swellable material section configured to contain at least a portion of the first swellable material, the first swellable material section having a first directional channel operatively connected to the first swellable material section, the first directional channel comprising a curved channel, the first movable arm configured to rotate on a second axis, the ... a first directional channel configured to contain at least a portion of a first swellable material section, the first contact element of the first movable arm being configured to substantially surround the first swellable material, the first movable arm or a portion thereof being configured to rotate on a first axis in a manner such that the first contact element slides within the first directional channel such that the first movable arm extends beyond or further away from the body of the oral drug dosage form, and one or more fluid inlets operably connected to the first swellable material section and the second swellable material section; a second swellable material section configured to be curved; and a second directional channel operatively connected to the second swellable material section, the second directional channel comprising a curved channel, the second movable arm comprising a second contact element configured to interact with the second swellable material proximate to the second directional channel, the second swellable material section and the second contact element of the second movable arm substantially surrounding the second swellable material, and the second movable arm, or a portion thereof, extending beyond or away from the body of the oral drug dosage form.a second movable arm including a second directional channel configured to rotate on a second axis in a manner such that the second contact element slides within the second directional channel, and one or more fluid inlets operatively connected to the second swellable material section; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention, the elongated dosage form of the post-administration state of the oral drug dosage form being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid.

[0047] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising a first swellable material and a first movable arm and a second movable arm, the first movable arm and the second movable arm configured such that at least a portion of each movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the first swellable material, the first movable arm and the second movable arm extending in substantially opposite directions along an axis based on a directional channel. a second movable arm, a second swellable material, a third movable arm, wherein the third movable arm is configured such that at least a portion of the third movable arm is extendable beyond or further from the body of the oral drug dosage form through a force provided by the second swellable material, and the third movable arm is configured to rotate on a first axis; a third swellable material, and a fourth movable arm, wherein at least a portion of the fourth movable arm is extendable beyond or further from the body of the oral drug dosage form through a force provided by the third swellable material. a fourth movable arm configured to rotate on a second axis, the body including a first swellable material section configured to contain at least a portion of a first swellable material, and a first directional channel and a second directional channel operably connected to the first swellable material section, the first movable arm including a first contact element configured to interact with the first swellable material in proximity to the first directional channel, and the second movable arm including a first contact element configured to interact with the first swellable material in proximity to the second directional channel. the first swellable material section and the first contact element of the first movable arm and the second contact element of the second movable arm substantially surround the first swellable material, the first movable arm or a portion thereof is configured to slide within the first directional channel such that the first movable arm extends beyond or further away from the body of the oral drug dosage form along the axis, and the second movable arm or a portion thereof is configured to slide within the first directional channel such that the second movable arm extends beyond or further away from the body of the oral drug dosage form along the axis.a first directional channel and a second directional channel configured to slide within the second directional channel; one or more fluid inlets operably connected to the first swellable material section; a first stop configured to engage with the first movable arm in an extended position; a second stop configured to engage with the second movable arm in an extended position; a second swellable material section configured to contain at least a portion of a second swellable material; and a third directional channel operably connected to the second swellable material section, the third directional channel extending from the curved channel. a third directional channel and a third movable arm operably connected to the third swellable material section, wherein the third movable arm includes a contact element configured to interact with the second swellable material proximate the third directional channel, the second swellable material section and the contact element of the third movable arm substantially encircling the second swellable material, and the third movable arm, or a portion thereof, is configured to rotate on a first axis in a manner such that the contact element slides within the third directional channel such that the third movable arm extends beyond or further away from the body of the oral drug dosage form; a third swellable material section configured to contain at least a portion of a third swellable material; a fourth directional channel operatively connected to the third swellable material section, the fourth directional channel comprising a curved channel; a fourth movable arm comprising a contact element configured to interact with the third swellable material proximate to the fourth directional channel, the third swellable material section and the contact element of the fourth movable arm substantially surrounding the third swellable material; and the fourth movable arm, or a portion thereof, is configured to be in contact with the third swellable material of the oral drug dosage form. a fourth movable arm including a fourth directional channel configured to rotate on a second axis in a manner such that the contact element slides within the fourth directional channel to extend beyond or further away from the body; and one or more fluid inlets operatively connected to the third swellable material section; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention, the elongated dosage form of the post-administration state of the oral drug dosage form being configured to expand in the presence of gastrointestinal fluids by the first swellable material, the second swellable material,and at least partially due to the expansion of the third swellable material.

[0048] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising: a swellable material; first and second movable arms, the first and second movable arms configured such that at least a portion of each movable arm is extendable beyond or away from a body of the oral drug dosage form via force provided by the swellable material; the first and second movable arms configured to rotate in opposite directions on a shared axis; the body comprising a swellable material section configured to contain at least a portion of the swellable material; and first and second directional channels operatively connected to the swellable material sections, the first and second directional channels being curved and configured about the shared axis; the first movable arm including a first contact element configured to interact with the swellable material proximate the first directional channel; the first contact element being ladder-shaped; and the first movable arm configured to rotate relative to the shared axis. the first and second directional channels being configured to move within the first directional channel to rotate beyond or further away from the body of the oral drug dosage form, the second movable arm including a second contact element configured to interact with the swellable material in proximity to the second directional channel, the second contact element being ladder-shaped, the second movable arm being configured to move within the second directional channel to rotate beyond or further away from the body of the oral drug dosage form relative to a shared axis, one or more fluid inlets operably connected to the swellable material section, and stops configured to engage the first and second movable arms in an extended position; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an extended dosage form that provides gastric retention, the extended dosage form of the oral drug dosage form in the post-administration state being due at least in part to the expansion of the swellable material in the presence of gastrointestinal fluid.

[0049] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising: a swellable material; a first movable arm, a second movable arm, a third movable arm, and a fourth movable arm, wherein the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the swellable material; a body, a swellable material compartment configured to contain at least a portion of the swellable material; and a directional channel and / or orifice operatively connected to the swellable material compartment, wherein each movable arm is configured to provide a directional channel and / or orifice adjacent to the directional channel and / or orifice to provide a ... the swellable material section, the contact element of the movable arm, and the cap substantially encircle the swellable material; a body including a directional channel and / or orifice operably connected to the swellable material section; one or more fluid inlets operably connected to the swellable material section; the cap; a first stop, a second stop, a third stop, and a fourth stop configured to engage with the first, second, third, and fourth movable arms, respectively, in an extended position; and a drug; wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an extended dosage form that provides gastric retention, the extended dosage form of the oral drug dosage form in the post-administration state being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid.

[0050] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising: a swellable material; a first movable arm, a second movable arm, a third movable arm, and a fourth movable arm, wherein the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the swellable material; a body, the body configured to contain at least a portion of the swellable material; and a directional channel and / or orifice operably connected to the swellable material section, wherein each movable arm is proximate to the directional channel and / or orifice. the oral drug dosage form comprises a body including a directional channel and / or orifice, the directional channel and / or orifice including a contact element configured to interact with the swellable material, wherein the contact elements of the swellable material section and the movable arm substantially surround the swellable material; one or more fluid inlets operably connected to the swellable material section; and a first stop, a second stop, a third stop, and a fourth stop configured to engage with the first, second, third, and fourth movable arms, respectively, in an extended position; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an extended dosage form that provides gastric retention, the extended dosage form of the oral drug dosage form in the post-administration state being due at least in part to the expansion of the swellable material in the presence of gastrointestinal fluid.

[0051] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising: a swellable material at least partially encased in a semipermeable membrane; a first movable arm, a second movable arm, a third movable arm, and a fourth movable arm, wherein the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the swellable material; and a body having a first connection point for the first arm, a second connection point for the second arm, a third connection point for the third arm, and a fourth connection point for the fourth arm, wherein each connection point is connected to the first arm, the second arm, the third arm, and the fourth arm. and a body including a first connection point, a second connection point, a third connection point, and a fourth connection point configured to provide independent axes of rotation for the first, second, third, and fourth arms, each movable arm including a contact element configured to interact with a swellable or semi-permeable material; and a first stop, a second stop, a third stop, and a fourth stop configured to engage the first, second, third, and fourth arms, respectively, in an extended position, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention, wherein the elongated dosage form of the oral drug dosage form in the post-administration state is due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid.

[0052] In another aspect, provided herein is a swellable structure for use in an oral drug dosage form, the swellable structure comprising: a swellable material; an outer shell comprising at least two layers, the at least two layers having successively smaller outer dimensions, the at least two layers configured to have a pre-administration state having a compact dosage form, at least two of the at least two layers sliding along an axis, the at least two layers configured to have a post-administration state having an stretched dosage form, the at least two layers stretching along the axis, the post-administration state having the stretched dosage form providing gastric retention; and one or more fluid inlets operably connected to a swellable material section, wherein the swellable structure is due, at least in part, to expansion of the swellable material in the presence of gastrointestinal fluid.

[0053] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising: an expandable material; a first movable arm, a second movable arm, a third movable arm, and a fourth movable arm, wherein the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the expandable material; a body, an expandable material section configured to contain at least a portion of the expandable material; and a directional channel and / or orifice operably connected to the expandable material section, wherein each movable arm has a directional channel and / or orifice. the expandable material section, the contact element of the movable arm, and the cap substantially enclose the expandable material; a directional channel and / or orifice; a body including a first stop, a second stop, a third stop, and a fourth stop configured to engage with the first, second, third, and fourth movable arms, respectively, in an extended position; and a drug; wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an extended dosage form that provides gastric retention, the extended dosage form of the oral drug dosage form in the post-administration state being due at least in part to expansion of the expandable material in the presence of gastrointestinal fluid. I. Definition

[0054] For purposes of interpreting this specification, the following definitions shall apply, and where appropriate, terms used in the singular shall include the plural and vice versa. In the event that any definition set forth below conflicts with any document incorporated herein by reference, the set forth definition shall control.

[0055] As used herein, the term "individual" refers to a mammal, including, but not limited to, a human, cow, horse, cat, canine, rodent, rat, mouse, dog, or primate. In some embodiments, the individual is a human individual.

[0056] As used herein, the terms "comprising," "having," "containing," and "including," other similar forms, and their grammatical equivalents, are intended to be equivalent in meaning and open-ended in that the item or items following any one of these terms are not meant to be an exhaustive list of such items or items, or to be limited to only the listed item or items. For example, an article "comprising" components A, B, and C can consist of (i.e., contain only) components A, B, and C, or can contain not only components A, B, and C, but also one or more other components. Thus, "comprises" and their similar forms, and their grammatical equivalents, are intended and understood to include disclosure of "consisting essentially of" or "consisting of" embodiments.

[0057] Where a range of values ​​is provided, unless the context clearly dictates otherwise, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range and any other stated or intervening value in that stated range, subject to any specifically excluded limit in the stated range, is encompassed within the disclosure. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0058] Reference herein to "about" a value or parameter includes (and describes) variations on that value or parameter itself. For example, a description that refers to "about X" includes a description of "X."

[0059] As used in this specification, including the appended claims, the singular forms "a," "an," "or," and "the" include plural referents unless the context clearly dictates otherwise. II. Oral Drug Dosage Forms Configured for Gastric Retention

[0060] In some embodiments, the present disclosure relates to a drug dosage form designed to provide a desired retention in an individual based on a geometric difference between the dosage form's pre-administration state and its post-administration state, e.g., a change in size in one or more dimensions. While some embodiments of the description provided herein illustrate oral drug dosage forms, it should be understood that the teachings of such dosage forms can be easily extrapolated to other drug dosage forms, such as dosage forms suitable for vaginal or rectal administration. In certain embodiments, provided herein are oral drug dosage forms and components thereof configured for gastric retention. The oral drug dosage forms provided herein are comprised of a swellable material, including one or more portions of swellable material comprised of the same or different materials, such that upon exposure to gastrointestinal fluids, the swellable material swells, providing a force that activates a mechanism that increases the size of the oral drug dosage form. This increase in size of the oral drug dosage form causes its retention in the stomach for an extended period of time, during which the oral drug dosage form cannot easily pass through the pylorus.

[0061] In some embodiments, the drug dosage form or a component thereof undergoes swelling by bodily fluids, for example, in some embodiments, the bodily fluids are gastrointestinal fluids.

[0062] In some aspects, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising a swellable material; a movable arm configured such that at least a portion of the movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the swellable material, the body comprising a swellable material section configured to contain at least a portion of the swellable material; and a directional channel and / or orifice operatively connected to the swellable material section, the directional channel and / or orifice configured to extend proximate the directional channel and / or orifice to accommodate the swellable material. a movable arm including a directional channel and / or orifice including a contact element configured to receive a force generated by the swellable material (e.g., configured to interact with the swellable material or a feature associated with the swellable material), one or more fluid inlets operably connected to the swellable material section, and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention, the elongated dosage form of the oral drug dosage form in the post-administration state being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid. In some embodiments, the drug is located within one or more of the movable arms or the body (or components thereof, such as the cap).

[0063] In some embodiments, the swellable material is a chemical composition. In some embodiments, the swellable material section includes a chemical composition and a plunger structure, the plunger structure having a certain stiffness, and the swelled composition pushes the movable arm to expand by pushing it to move toward the orifice. In some embodiments, a piston is pushed past the orifice. In some embodiments, the piston moves toward the orifice until it is blocked by a cap. In some embodiments, the plunger structure is a piston having a stiffness greater than that of the expanding composition.

[0064] In another aspect, provided herein is an oral drug dosage form configured for gastric retention, the oral drug dosage form comprising: a swellable material at least partially surrounded by a semipermeable membrane, wherein in some embodiments the body and the base are all semipermeable membranes; a first movable arm, a second movable arm, a third movable arm, and a fourth movable arm, wherein the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the swellable material; and a body having a first connection point for the first arm, a second connection point for the second arm, a third connection point for the third arm, and a fourth connection point for the fourth arm, wherein each connection point is connected to a first arm. a body including a first connection point, a second connection point, a third connection point, and a fourth connection point configured to provide independent axes for rotation of the arm, the second arm, the third arm, and the fourth arm, each of the movable arms including a contact element configured to interact with a swellable material or a semi-permeable material; and a first stop, a second stop, a third stop, and a fourth stop configured to engage the first arm, the second arm, the third arm, and the fourth arm, respectively, in an extended position, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an extended dosage form that provides gastric retention, wherein the extended dosage form of the oral drug dosage form in the post-administration state is due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid.

[0065] As described herein, oral drug dosage forms include moving parts, such as those involved in the transition between a pre-administration state (e.g., compact for oral administration) and a post-administration state (e.g., stretched for gastric retention). Thus, there may be some variation between the most compact and most stretched states reached by the oral drug dosage form during use. The description of a single pre-administration state and a single post-administration state is not intended to limit the scope of the description provided herein, and as taught herein, there may be more than one pre-administration state and / or more than one post-administration state that an oral drug dosage form experiences during its administration lifecycle. Furthermore, the oral drug dosage forms provided herein are configured to ultimately be completely removed from the stomach of an individual to whom the oral drug dosage form is administered.

[0066] Additional sections are provided below to teach exemplary mechanisms for providing gastric retention in oral drug dosage forms and specific aspects of oral drug dosage forms. Such module descriptions are not intended to limit the scope of the descriptions provided herein, and based on the teachings provided herein, one skilled in the art will readily understand that the descriptions encompass any combination of modules that are brought together to form an oral drug dosage form with gastric retention. A. Examples of Oral Drug Dosage Forms

[0067] For purposes of illustration and description of the subject matter provided herein, specific drug dosage forms, such as oral drug dosage forms, are described below. As described, the basic teachings described herein enable various movable arm mechanisms to provide size increases in oral drug dosage forms so that the oral drug dosage form does not easily pass through the pylorus for a desired period of time, thereby exhibiting a period of gastric retention. In certain aspects, the oral drug dosage forms taught herein include a single taught mechanism for size increase after administration. In some embodiments, two or more instances of a single mechanism, such as a sliding arm, may be used in a single oral drug dosage form. In certain aspects, the oral drug dosage forms taught herein include two or more taught mechanisms for size increase after administration, such as the use of two styles of movable arms.

[0068] An exemplary oral drug dosage form 100 configured for gastric retention is shown in Figures 1A-1C. As shown in the pre-administration state in Figure 1A, the oral drug dosage form 100 includes a swellable material 102 contained in a swellable material compartment 106 formed by a body 104 of the oral drug dosage form 100. The oral drug dosage form 100 includes a movable arm 108 that is located within (or substantially within) the footprint of the oral drug dosage form 100 in the pre-administration state. The movable arm 108 is configured such that at least a portion of the movable arm is extendable beyond or further away from the body 104 of the oral drug dosage form 100 via a force provided by the swellable material 102. The body 104 of the oral drug dosage form 100 forms a directional channel 110 configured to guide the movement of the movable arm 108 as the swellable material 102 swells. In the pre-administration state, the oral drug dosage form 100 is designed such that the movable arm 108 includes a contact element 112 configured to interact with the swellable material 102 proximate the directional channel 110. As the swellable material 102 swells, it pushes against the contact element 112 of the movable arm 108, causing the movable arm 108 to move. The body 104 also forms a stop 114 configured to engage with the movable arm 108 in the extended position. A post-administration state of the oral drug dosage form 100 is shown in FIG. 1B. In the post-administration state, gastrointestinal fluids have entered the oral drug dosage form 100 such that the swellable material 102 swells and pushes the movable arm 108 through the directional channel 110 against the stop 114. A component view of the oral drug dosage form 100 is shown in FIG. 1C. 1C, the body 104 of the oral drug dosage form 100 may include a frame 116 and caps 118, 120. In certain embodiments, the frame 116, or portions thereof, comprises a semi-permeable material that allows gastrointestinal fluids to contact the swellable material. In some embodiments, the semi-permeable material provides gastrointestinal fluid access to the swellable material section 106. In some embodiments, the semi-permeable material provides gastrointestinal fluid access to the directional channels 110 so that the swellable material can continue to absorb gastrointestinal fluids while swelling. In some embodiments, the oral drug dosage form may include one or more fluid inlets, at least one of which is a pore.A component view of oral drug dosage form 100 is shown in FIG. 1D. As shown in FIG. 1C, certain oral drug dosage forms may have a seamless transition between the swellable material compartment and the directional channel, and boundaries may be assigned for illustrative purposes consistent with the teachings provided herein. In some embodiments, the components of oral drug dosage form 100 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form oral drug dosage form 100 pre-administered. For example, in some embodiments, the body (or one or more portions thereof) is produced independently from the movable arm, and then such components are assembled to form the oral drug dosage form.

[0069] An exemplary oral drug dosage form 200 configured for gastric retention is shown in Figures 2A-2C. As shown in the pre-administration state in Figure 2A, the oral drug dosage form 200 includes a swellable material 202 contained in a swellable material compartment 206 formed by a body 204 of the oral drug dosage form 200. The oral drug dosage form 200 includes a movable arm 208 located within (or substantially within) the footprint of the oral drug dosage form 200 in the pre-administration state. The movable arm 208 is configured such that at least a portion of the movable arm is extendable beyond or further away from the body 204 of the oral drug dosage form 200 via a force provided by the swellable material 202. The body 204 of the oral drug dosage form 200 forms a directional channel 210 configured to guide the movement of the movable arm 208 as the swellable material 202 swells. In the pre-administration state, oral drug dosage form 200 is designed such that movable arm 208 includes a contact element 212 configured to interact with swellable material 202 adjacent directional channel 210. As swellable material 202 swells, it pushes against contact element 212 of movable arm 208, causing movable arm 208 to move. Body 204 also forms a stop 214 including a locking element configured to maintain movable arm 208 in an extended position in the post-administration state. The post-administration state of oral drug dosage form 200 is shown in FIG. 2B. In the post-administration state, gastrointestinal fluid has entered oral drug dosage form 200 such that swellable material 202 swells and pushes movable arm 208 through directional channel 210 against stop 214 including the locking element. As shown in FIG. 2B, a portion of the movable arm 208 engages with the locking element such that the movable arm 208 is maintained in an extended position (preventing substantial movement in the direction of or opposite to the movement of the movable arm within the directional channel). A component view of the oral drug dosage form 200 is shown in FIG. 2C. As shown in FIG. 2C, the body 204 of the oral drug dosage form 200 may include a frame 216 and caps 218, 220. In certain embodiments, the frame 216, or portions thereof, comprises a semi-permeable material that allows gastrointestinal fluids to contact the swellable material. In some embodiments, the semi-permeable material provides gastrointestinal fluid access to the swellable material section 206.In some embodiments, the semi-permeable material provides gastrointestinal fluid access to the directional channels 210 so that the swellable material can continue to absorb gastrointestinal fluid while swelling. In some embodiments, the oral drug dosage form may include one or more fluid inlets, at least one of which is a pore. A component view of the body 204 and the movable arm 208 is shown in FIG. 2D. As shown in FIG. 2C, certain oral drug dosage forms may have a seamless transition between the swellable material compartment and the directional channels, and the boundary may be assigned for illustrative purposes consistent with the teachings provided herein. In some embodiments, the components of the oral drug dosage form 200 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form the oral drug dosage form 200 prior to administration. For example, in some embodiments, the body (or one or more portions thereof) is produced independently from the movable arm, and then such components are assembled to form the oral drug dosage form.

[0070] As shown in Figures 2E and 2F, an alternative design of oral drug dosage form 200 is provided. Specifically, oral drug dosage form 250 shown in Figures 2E and 2F has a different locking element 264, which engages with one side of movable arm 260. Body 254 of oral drug dosage form 250 forms swellable material section 256, directional channel 258, and a stop including locking element 264. Swellable material 252 is contained within swellable material section 256. Movable arm 260 is provided with contact surface 262. In post-dosing state diagram 2F, swellable material 252 has pushed movable arm 260 into an extended position via contact surface 262 such that movable arm 260 engages with locking element 264 of the stop of oral drug dosage form 250. A component view of body 254 and movable arm 260 is shown in Figure 2G.

[0071] An exemplary oral drug dosage form 300 configured for gastric retention is shown in Figures 3A and 3B. As shown in the pre-administration state in Figure 3A, the oral drug dosage form 300 includes a swellable material 302 contained in a swellable material compartment 306 formed by a body 304 of the oral drug dosage form 300. The oral drug dosage form 300 includes a movable arm 308 that is located within (or substantially within) the footprint of the oral drug dosage form 300 in the pre-administration state. The movable arm 308 is configured such that at least a portion of the movable arm is extendable beyond or further away from the body 304 of the oral drug dosage form 300 via a force provided by the swellable material 302. The body 304 of the oral drug dosage form 300 forms a directional channel 310 configured to guide the movement of the movable arm 308 as the swellable material 302 swells. In the pre-administration state, oral drug dosage form 300 is designed such that movable arm 308 includes a contact element 312 configured to interact with swellable material 302 adjacent directional channel 310. As swellable material 302 swells, it pushes against contact element 312 of movable arm 308, causing movable arm 308 to move. Body 304 also forms a stop 314 including a locking element configured to maintain movable arm 308 in an extended position in the post-administration state. The post-administration state of oral drug dosage form 300 is shown in FIG. 3B. In the post-administration state, gastrointestinal fluid has entered oral drug dosage form 300 such that swellable material 302 swells and pushes movable arm 308 through directional channel 310 against stop 314 including the locking element. As shown in FIG. 3B, the locking element includes several steps that can engage with the movable arm in various extended positions. In some embodiments, the post-administration state may be any one or more of the extended positions provided by the several steps of the stopper's locking element. As shown in Figure 3B, a portion of the movable arm 308 engages the locking element such that the movable arm 308 is maintained in the extended position (note that substantial movement in the direction of or opposite to the movement of the movable arm within the directional channel is prevented, but movement of the most extended step of the locking element is permitted for the step before the last step to allow further extension).A component view of oral drug dosage form 300 is shown in Figure 3C.

[0072] An exemplary oral drug dosage form 400 configured for gastric retention is shown in Figures 4A-4C. As shown in the pre-administration state in Figure 4A, the oral drug dosage form 400 includes a swellable material 402 contained in a swellable material compartment 406 formed by a body 404 of the oral drug dosage form 400. The oral drug dosage form 400 includes a first movable arm 408 located within (or substantially within) the footprint of the oral drug dosage form 400 in the pre-administration state. The movable arm 408 is configured such that at least a portion of the movable arm is extendable beyond or further away from the body 404 of the oral drug dosage form 400 via a force provided by the swellable material 402. The body 404 of the oral drug dosage form 400 forms a directional channel 410 configured to guide the movement of the movable arm 408 as the swellable material 402 swells. In the pre-dosage state, the oral drug dosage form 400 is designed such that the movable arm 408 includes a contact element 412 configured to interact with the swellable material 402 adjacent the directional channel 410. The oral drug dosage form 400 includes a plurality of fluid inlets (four in the figure) in the form of pores 416 operably connected to the swellable material section 406. As the swellable material 402 swells, it pushes against the contact element 412 of the movable arm 408, causing the movable arm 408 to move. The body 404 also forms a stop 414 configured to stop the movable arm 408 in an extended position in the post-dosage state. The oral drug dosage form 400 further includes a second movable arm 418 having a contact element 420 configured to interact with the swellable material 402. The second movable arm 418 is configured with respect to a second directional channel 422, and the second movable arm 418 moves within the second directional channel 422 to a stop 424. A post-administration state of a portion of the oral drug dosage form 400 is shown in FIG. 4B. In the post-administration state, gastrointestinal fluid has entered the oral drug dosage form 400 through the fluid inlet including the pores 416, causing the swellable material 402 to swell and push the first movable arm 408 and the second movable arm 418 against their respective stops 414, 424 such that the first movable arm 408 and the second movable arm 418 are maintained in an extended position. Component views of the oral drug dosage form 400 are shown in FIGS. 4C and 4D.As shown in Figure 4C, certain oral drug dosage forms may have a seamless transition between the swellable material compartment and the directional channel, and boundaries may be assigned for illustrative purposes consistent with the teachings provided herein. In some embodiments, components of oral drug dosage form 400 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form pre-administered oral drug dosage form 400. For example, in some embodiments, the body (or one or more portions thereof) is produced independently from the first and second movable arms, and then such components are assembled to form the oral drug dosage form.

[0073] An exemplary oral drug dosage form 500 configured for gastric retention is shown in Figures 5A-5F. As shown in the pre-administration state in Figure 5A, the oral drug dosage form 500 includes a first swellable material 502 contained in a first swellable material compartment 506 formed by a body 504 of the oral drug dosage form 500. The oral drug dosage form 500 includes a first movable arm 508 located within (or substantially within) the footprint of the oral drug dosage form 500 in the pre-administration state. The first movable arm 508 is configured such that at least a portion of the first movable arm is extendable beyond or further away from the body 504 of the oral drug dosage form 500 via a force provided by the first swellable material 502. The body 504 of the oral drug dosage form 500 forms a first directional channel 510 configured to guide the movement of the first movable arm 508 as the first swellable material 502 swells. In a pre-administration state, the oral drug dosage form 500 is designed such that the first movable arm 508 includes a contact element 512 configured to interact with the first swellable material 502 in proximity to the first directional channel 510. The oral drug dosage form 500 includes a plurality of fluid inlets (four in the figure) in the form of pores 516 operably connected to the first swellable material section 506. As the first swellable material 502 swells, the first swellable material 502 pushes against the contact element 512 of the first movable arm 508, causing the first movable arm 508 to move. The first directional channel includes a plurality of fluid inlets (four in the figure) in the form of pores 518 operably connected to the first directional channel 510, thereby keeping the first swellable material 502 exposed to gastrointestinal fluids as the first movable arm 508 moves through the first directional channel 510. Body 504 also forms a first stop 514 configured to stop first movable arm 508 in an extended position in the post-dosing state. Oral drug dosage form 500 further includes a second movable arm 520 having a matching movement mechanism as first movable arm 508. Both the first movable arm and second movable arm are configured to rotate on an axis (such as 522 of second movable arm 520). The post-dosing state of oral drug dosage form 500 is shown in FIG. 5B.In the post-dosing state, gastrointestinal fluids enter the oral drug dosage form 500 through a fluid inlet comprising pores (such as 516 and 518 associated with the first swellable material), causing the swellable material (such as the first swellable material 502 associated with the first movable arm 508) to press the movable arms 508, 520 against their respective stops (such as the first stop 514 associated with the first movable arm 508) such that the first and second movable arms 508, 520 are configured in an extended position. Additional pre-dosing and post-dosing state diagrams of the oral drug dosage form 500 are shown in Figures 5C and 5D, respectively. As shown in Figures 5C and 5D, the body 504 of the oral drug dosage form 500 may include a frame 524 and a cap 526. Component views and accompanying schematic diagrams of a particular embodiment of the oral drug dosage form 500 are shown in Figures 5E and 5F. As shown in frame view 524 of FIG. 5E, certain oral drug dosage forms may have a seamless transition between the swellable material compartment and the directional channel, and boundaries may be assigned for illustrative purposes consistent with the teachings provided herein. In some embodiments, components of oral drug dosage form 500 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form pre-administered oral drug dosage form 500. For example, in some embodiments, the body (or one or more portions thereof) is produced independently from the first movable arm and the second movable arm, and then such components are assembled to form the oral drug dosage form.

[0074] As taught herein, an oral drug dosage form may include a movable arm configured with different movement mechanisms. An exemplary oral drug dosage form 600 configured for gastric retention is shown in FIGS. 6A-6H. As shown in the pre-administration state in FIG. 6A, the oral drug dosage form 600 includes a body 602 including a first swellable material 604 in a first swellable material section 606. The body 602 includes a first set of fluid inlets including pores 608 (four shown) operably connected to the first swellable material section 606. The body 602 includes a first directional channel 610 and a second directional channel 612 operably connected to the first swellable material section 606. A first movable arm 614 is located within the first directional channel 610, and a second movable arm 616 is located within the second directional channel 612. The oral drug dosage form 600 is configured in a pre-dosage state such that the first movable arm 614 and the second movable arm 616 are located within (or substantially within) the footprint of the oral drug dosage form 600. The first movable arm 614 and the second movable arm 616 are configured to be extendable beyond or further away from the body 602 of the oral drug dosage form 600 via a force provided by the first swellable material 604. The first directional channel 610 and the second directional channel 612 are configured to guide the movement of the first movable arm 614 and the second movable arm 616 (respectively) as the first swellable material 604 expands. The body 602 of the oral drug dosage form 600 further includes a second swellable material 618 in a second swellable material section 620. The body 602 includes a second set of fluid inlets including pores 622 (two shown) operably connected to the second swellable material section 620. The body 602 includes a third directional channel 634 operably connected to the second swellable material section 620. The third movable arm 614 is located within the third directional channel 634. The oral drug dosage form 600 is configured in a pre-dosage state such that the third movable arm 630 is located within (or substantially within) the footprint of the oral drug dosage form 600.The third movable arm 630 is configured to be extendable beyond or further away from the body 602 of the oral drug dosage form 600 via a force provided by the second swellable material 618. The third directional channel 634 is configured to guide the movement of the third movable arm 630 as the second swellable material 618 expands. The body 602 of the oral drug dosage form 600 further includes a third swellable material 624 in a third swellable material section 626. The body 602 includes a third set of fluid inlets including pores 628 (two shown) operably connected to the third swellable material section 626. The body 602 includes a fourth directional channel 636 operably connected to the third swellable material section 626. The fourth movable arm 632 is located within the fourth directional channel 636. The oral drug dosage form 600 is configured in a pre-dosage state such that the fourth movable arm 632 is located within (or substantially within) the footprint of the oral drug dosage form 600. The fourth movable arm 632 is configured to be extendable beyond or further away from the body 602 of the oral drug dosage form 600 via a force provided by the third swellable material 624. The fourth directional channel 636 is configured to guide the movement of the fourth movable arm 632 as the third swellable material 624 expands. An alternative view of the oral drug dosage form 600 in a pre-dosage state is shown in FIG. 6B, with only certain features labeled to guide points to understanding the features of the oral drug dosage form 600. The post-dosage state of oral drug dosage form 600 is shown in FIG. 6C, which shows first movable arm 614, second movable arm 616, third movable arm 630, and fourth movable arm 632 in an extended position beyond body 602 of oral drug dosage form 600. An alternative view of the post-dosage state of oral drug dosage form 600 is shown in FIG. 6D, with only certain features labeled to guide points for understanding the features of oral drug dosage form 600. Component views and schematic diagrams of oral drug dosage form 600 are shown in FIGS. 6E-6H. As shown in FIGS. 6E and 6F, body 602 may be composed of two or more modules, such as 602a and 602b. FIG. 6E shows body 602a in relation to the first and second movable arms.Figure 6F shows the body 602b associated with the third and fourth movable arms. Figure 6G shows a diagram and schematic of the first and second movable arms. Figure 6H shows a diagram and schematic of the third and fourth movable arms. In some embodiments, the components of the oral drug dosage form 600 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form the oral drug dosage form 600 pre-administered. For example, in some embodiments, the body (or one or more portions thereof) is produced independently from the first and second movable arms, and then such components are assembled to form the oral drug dosage form.

[0075] An exemplary oral drug dosage form 700 is shown in Figures 7A-7I. As shown in Figures 7A and 7B, in a pre-administration state, oral drug dosage form 700 includes a body 702, a first movable arm 704, and a second movable arm 706 that form a capsule-like oral drug dosage form. A post-administration state of oral drug dosage form 700 is shown in Figure 7C, in which first movable arm 704 and second movable arm 706 are positioned beyond or further away from body 702 of oral drug dosage form 700. In the post-administration state diagram, a set of fluid inlets in the form of pores 710 are shown on body 702, which are operably connected to a swellable material section 708 that contains at least a portion of the swellable material. To explain the mechanism of oral drug dosage form 700, a cross-sectional view of oral drug dosage form 700 in a pre-administration state (Figure 7D) and a cross-sectional view of oral drug dosage form 700 in a post-administration state (Figure 7E) are shown and will be further discussed. As shown in Figure 7D, the body 702 of the oral drug dosage form 700 includes a swellable material section 708, a first directional channel 718, and a second directional channel 724. The swellable material section 708 includes a swellable material 714. In Figure 7D, a first arm (not fully shown) includes a ladder-shaped feature 716 configured to move in the first directional channel 718, the ladder-shaped feature 716 including a contact element 720 configured to interact with the swellable material 714. As further shown in Figure 7D, a second arm (not fully shown) includes a ladder-shaped feature 722 configured to move in the second directional channel 724, the ladder-shaped feature 722 including a contact element 726 configured to interact with the swellable material 714. 7E, in the post-dosage state, the swellable material 714 expands into the first directional channel 718 and the second directional channel 724 and applies a force to the first and second movable arms via their respective ladder-shaped features. The oral drug dosage form 700 is configured so that the first and second movable arms rotate on an axis 730 until they reach a stop 728.Specifically, ladder-shaped feature 716 of the first movable arm and ladder-shaped feature 722 of the second movable arm move in their respective directional channels, causing each movable arm to extend beyond or further away from body 702 of oral drug dosage form 700. An additional view of oral drug dosage form 700 is shown in FIG. 7F, which shows first movable arm 704 and second movable arm 706 in an extended, post-dosage state, with ladder-shaped features 716, 722 of first movable arm 704 and second movable arm 706 being pushed by swellable material 714 to contact stop 728. The size of oral drug dosage form 700 in the post-dosage state provides gastric retention because its increased size prevents it from easily passing through the pylorus. Component views and schematic diagrams of embodiments of oral drug dosage form 700 are shown in FIGS. 7G-7I. In some embodiments, the components of oral drug dosage form 700 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form pre-administered oral drug dosage form 700. For example, in some embodiments, the body (or one or more portions thereof) is produced independently from the first and second movable arms, and then such components are assembled to form the oral drug dosage form.

[0076] An exemplary dosage form having four movable arms is shown in Figures 8A-8I. A pre-administration state of oral drug dosage form 800 is shown in Figure 8A, where oral drug dosage form 800 includes a body 802 having a swellable material compartment 804 configured to contain at least a portion of a swellable material 810. The body includes a set of fluid inlets 808 operably connected to swellable material compartment 804. Body 802 includes directional channels 806 operably connected to swellable material compartment 804, such that upon swelling, swellable material 810 may swell in a direction guided by directional channels 806. Swellable material 810 may be configured with non-swelling features, such as to maintain a particular shape of at least a portion of the swellable material and / or to contact contact elements of one or more movable arms. As shown in FIG. 8A, the swellable material is embedded in non-swellable features covering the top of the swellable material in a pre-dosed state (as shown in FIG. 8C below, non-swellable features 828 covering the top of swellable material 810 contact each of the movable arms upon application of an upward force). The body of oral drug dosage form 800 includes a cap 812. Oral drug dosage form 800 includes four movable arms (the view in FIG. 8A shows three of movable arms 814, 816, 818), each configured such that at least a portion of each movable arm is extendable beyond or further away from the body of oral drug dosage form 800 via a force provided by swellable material 810. Specifically, each movable arm is configured to rotate on an axis. For example, first movable arm 814 is configured to rotate on first axis 824. The movable arms may contain a feature 826 configured to engage a stop on oral drug dosage form 800. As shown in the pre-dosing state shown in Figure 8A, the oral drug dosage form may further include an erodible restraint 822 configured to prevent extension of the movable arm in the pre-dosing state. Oral drug dosage form 800 shown in Figure 8B does not have an erodible restraint, which may be an embodiment of oral drug dosage form 800 in the pre-dosing state or oral drug dosage form 800 in the post-dosing state, in which the erodible restraint erodes but the movable arm still moves to the extended position.A cross-sectional view of oral drug dosage form 800 is shown in FIG. 8C , where swellable material 810 swells as guided by directional channels 806 in body 802, applying a force on each movable arm (via non-swellable features 828 covering the top of swellable material 810) such that each movable arm moves to an extended position until it reaches stop 826. FIG. 8D shows a top view of oral drug dosage form 800 in a post-dosage state, with first movable arm 814, second movable arm 816, third movable arm 818, and fourth movable arm 820 shown in an extended position. Component views and schematic diagrams of embodiments of oral drug dosage form 800 are shown in FIGS. 8E-8I . In some embodiments, components of oral drug dosage form 800 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form pre-administered oral drug dosage form 800. For example, in some embodiments, the body (or one or more portions thereof, e.g., cap 812) is generated independently from each movable arm, and then such components are assembled to form the oral drug dosage form.

[0077] An exemplary dosage form having four movable arms is shown in Figures 9A-9I. A pre-administration state of oral drug dosage form 900 is shown in Figure 9A, where oral drug dosage form 900 includes a body 902 having a swellable material compartment 904 configured to contain at least a portion of a swellable material 910. The body includes a set of fluid inlets 908 operably connected to swellable material compartment 904. Body 902 includes an orifice 906 operably connected to swellable material compartment 904, and upon swelling, swellable material 910 may extend outwardly from and beyond orifice 906 (or at least to a greater extent if the swellable material already protrudes through the orifice). Swellable material 910 may be configured with non-swelling features, such as to maintain a particular shape of at least a portion of the swellable material and / or to contact a contact element of one or more movable arms. As shown in FIG. 9A, the swellable material is embedded in non-swellable features covering the top of the swellable material in a pre-dosed state (as shown in FIG. 9C below, non-swellable features 928 covering the top of swellable material 910 contact each of the movable arms when an upward force is applied). The body of oral drug dosage form 900 includes a cap 912. Oral drug dosage form 900 includes four movable arms (the view in FIG. 9A shows three of movable arms 914, 916, 918), each configured such that at least a portion of each movable arm is extendable beyond or further away from the body of oral drug dosage form 900 via a force provided by swellable material 910. Specifically, each movable arm is configured to rotate on an axis. For example, first movable arm 914 is configured to rotate on a first axis 924. As shown in the pre-dosing state shown in Figure 9A, oral drug dosage form 900 may further include an erodible restraint 922 configured to prevent extension of the movable arm in the pre-dosing state. Oral drug dosage form 900 shown in Figure 9B does not have an erodible restraint, which may be an embodiment of oral drug dosage form 900 in the pre-dosing state or oral drug dosage form 900 in the post-dosing state, in which the erodible restraint erodes but the movable arm still moves to the extended position.A cross-sectional view of oral drug dosage form 900 is shown in FIG. 9C , where swellable material 910 swells (at least partially) through and beyond orifice 906 in body 902, applying a force on each movable arm (via non-swellable feature 928 covering the top of swellable material 910) such that each movable arm moves to an extended position. FIG. 9D shows a top view of oral drug dosage form 900 in a post-dosage state, with first movable arm 914, second movable arm 916, third movable arm 918, and fourth movable arm 920 shown in an extended position. Component views and schematic diagrams of embodiments of oral drug dosage form 900 are shown in FIGS. 9E-9I . In some embodiments, components of oral drug dosage form 900 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form pre-administered oral drug dosage form 900. For example, in some embodiments, the body (or one or more portions thereof, e.g., cap 912) is generated independently from each movable arm, and then such components are assembled to form the oral drug dosage form.

[0078] An exemplary dosage form having four movable arms is shown in Figures 10A-10F. A pre-administration state of an oral drug dosage form 1000 is shown in Figure 10A, where the oral drug dosage form 1000 includes a body 1002 having a swellable material section 1004 configured to contain at least a portion of a swellable material 1010. The body includes a set of fluid inlets 1008 operably connected to the swellable material section 1004. The body 1002 includes an orifice 1006 operably connected to the swellable material section 1004, and upon swelling, the swellable material 1010 may extend outwardly from and beyond the orifice 1006 (or at least to a greater extent if the swellable material already protrudes through the orifice). The swellable material 1010 may be configured with non-swelling features, such as to maintain a particular shape of at least a portion of the swellable material and / or to contact a contact element of one or more movable arms. As shown in FIG. 10A, the swellable material is embedded in a non-swellable feature that encapsulates the swellable material in a pre-dosed state (as shown in FIG. 10C below, non-swellable feature 1028 expands with swellable material 1010 and contacts each of the movable arms). The non-swellable feature may be or include a semi-permeable material that allows gastrointestinal fluids to enter the swellable material. In some embodiments, the oral drug dosage form may include one or more fluid inlets, at least one of which is a pore. The oral drug dosage form 1000 includes four movable arms (the view in FIG. 10A shows three of the movable arms 1014, 1016, 1018), each configured such that at least a portion of each movable arm is extendable beyond or further from the body of the oral drug dosage form 1000 via force provided by the swellable material 1010. Specifically, each movable arm is configured to rotate on an axis. For example, first movable arm 1014 is configured to rotate on first axis 1024. As shown in the pre-dosing state depicted in FIG. 10A, oral drug dosage form 1000 may further include an erodible restraint 1022 configured to prevent extension of the movable arm in the pre-dosing state.10B does not have an erodible restraint, which may be an embodiment of the oral drug dosage form 1000 in a pre-administration state or the oral drug dosage form 1000 in a post-administration state, in which the erodible restraint has eroded but the movable arms still move to the extended position. A cross-sectional view of oral drug dosage form 1000 is shown in FIG. 10C, in which the swellable material 1010 has swelled (at least partially) through and beyond the orifice 1006 in the body 1002, applying a force on each movable arm (via a non-swellable feature, i.e., semi-permeable material 1028 surrounding the swellable material 1010) such that each movable arm moves to the extended position. FIG. 10D shows a top view of the post-administration state of oral drug dosage form 1000, with first movable arm 1014, second movable arm 1016, third movable arm 1018, and fourth movable arm 1020 shown in an extended position. Component views of swellable material 1010 surrounded by non-swellable features 1028 are shown for the pre-administration state ( FIG. 10E ) and for the post-administration state ( FIG. 10F ). In some embodiments, the post-administration state forms a design shape provided by the swellable material and / or non-swellable features. In some embodiments, the components of oral drug dosage form 1000 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form pre-administration oral drug dosage form 1000. For example, in some embodiments, the body (or one or more portions thereof) is produced independently from each movable arm, and then such components are assembled to form the oral drug dosage form.

[0079] An exemplary dosage form having four movable arms is shown in Figures 11A-11E. The pre-dosage state of oral drug dosage form 1100 is shown in Figure 11A, where oral drug dosage form 1100 includes a body 1102 including a connection point for each movable arm. Oral drug dosage form 1100 includes four movable arms (the view in Figure 11A shows three of the movable arms 1114, 1116, 1118), each configured such that at least a portion of each movable arm is extendable beyond or away from the body of oral drug dosage form 1100 via a force provided by swellable material 1110. Each movable arm is configured to rotate on an axis. For example, first movable arm 1114 is configured to rotate on first axis 1124. The swellable material 1110 may be configured in conjunction with non-swellable features 1128 to maintain a particular shape of at least a portion of the swellable material and / or to contact a contact element of one or more movable arms, etc. As shown in FIG. 11A , the swellable material 1110 and associated non-swellable features 1128 are located on top of the body 1102 and between the movable arms. In some embodiments, the oral drug dosage form may include an erodible restraint around the movable arms. The non-swellable material 1128 associated with the swellable material 1110 is a semi-permeable material that allows gastric fluids to enter the swellable material. In some embodiments, the oral drug dosage form may include one or more fluid inlets, at least one of which is a pore. A cross-sectional view of the oral drug dosage form 1100 is shown in FIG. 11B , in which the swellable material 1110 swells and applies a force on each movable arm (via the non-swellable features 1128) such that each movable arm moves to an extended position. 11C shows a top view of oral drug dosage form 1100 in a post-dosage state, with first movable arm 1114, second movable arm 1116, third movable arm 1118, and fourth movable arm 1120 shown in an extended position. Component views and schematic diagrams of aspects of oral drug dosage form 1100 are shown in FIGS. 11D and 11E. In some embodiments, components of oral drug dosage form 1100 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form oral drug dosage form 1100 pre-dosage.

[0080] As taught herein, in some embodiments, a swellable material (and optionally any associated non-swelling characteristics) may have a desired pre-administration state and a desired post-administration state. For example, in certain dosage forms taught herein, a swellable material (and optionally any associated non-swelling characteristics) is provided that acquires a specific post-administration state structure after swelling occurs via exposure to gastrointestinal fluids. An example of this concept is provided in expanded structure 1200 of FIGS. 12A-12E. In FIG. 12A, swellable material 1202 and associated shell 1204 are shown in a pre-administration state from a side view, with swellable material 1202 being a core within associated shell 1204 that forms swelled structure 1200. Shell 1204 is configured to expand into a shape having at least two layers with successively smaller overall dimensions. Associated shell 1204 includes a means for water to access swellable material 1202, e.g., pores and / or a semi-permeable material. A top view of the swellable material 1202 and associated shell 1204 is shown in Figure 12B. As can be seen from the top view in Figure 12B, there are four layers 1206, 1208, 1210, and 1212 nested together in a concentric arrangement in the pre-dosed state. A post-dosed state diagram of the swellable structure 1200 is shown in Figures 12C and 12D, in which the swellable material 1202 expands to fill the associated shell 1204 as the nested layers 1206, 1208, 1210, and 1212 expand to an expanded state. Additional diagrams and schematics are shown in Figures 12E and 12F. Another example of this concept is shown in swellable structure 1300 in Figures 13A-13E. In Figure 13A, the swellable material 1302 and associated shell 1304 are shown in a pre-administration state from a side view, with the swellable material 1302 being a base and protruding core within the associated shell 1304 that form the swollen structure 1300. The shell 1304 is configured to expand into a shape having at least two layers with successively smaller overall dimensions. The associated shell 1304 includes a means, e.g., pores and / or a semi-permeable material, for water to access the swellable material 1302. A top view of the swellable material 1302 and associated shell 1304 is shown in Figure 13B.As can be seen from the top view in Figure 13B, there are four layers 1306, 1308, 1310, 1312 nested together in a concentric arrangement in the pre-dosed state. A post-dosed state diagram of the swollen structure 1300 is shown in Figures 13C and 13D, in which the swollen material 1302 expands such that the nested layers 1306, 1308, 1310, 1312 expand to the expanded state, filling the associated shell 1304. Additional diagrams and schematics are shown in Figures 13E and 13F.

[0081] An exemplary dosage form having four movable arms is shown in Figures 14A and 14B, where the oral drug dosage form includes a column configured to push against the movable arms with a force provided by a swellable material. A pre-administration state of oral drug dosage form 1400 is shown in Figure 14A, where oral drug dosage form 1400 includes a body 1402 having a swellable material section 1404 configured to contain at least a portion of a swellable material 1410. The body includes a set of fluid inlets 1408 operably connected to swellable material section 1404. Column 1412 is located at the top of swellable material 1410. Body 1402 includes an orifice operably connected to swellable material section 1404, and upon swelling, swellable material 1410 pushes against column 1412, and at least a portion of the column may extend outward from and beyond the orifice. Oral drug dosage form 1400 includes four movable arms (the view in FIG. 14A shows four of movable arms 1416, 1418, 1420, 1422), each configured such that at least a portion of each movable arm is extendable beyond or away from the body of oral drug dosage form 1400 via force provided by swellable material 1410. Specifically, each movable arm is configured to rotate on an axis. A cross-sectional view of oral drug dosage form 1400 is shown in FIG. 14B, in which swellable material 1410 swells and applies a force to each movable arm, pushing against column 1412, such that each movable arm moves to an extended position. In some embodiments, components of oral drug dosage form 1400 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form oral drug dosage form 1400 prior to administration. For example, in some embodiments, the body (or one or more portions thereof) is generated independently from each movable arm, and then such components are assembled to form the oral drug dosage form.

[0082] An exemplary oral drug dosage form 1500 including four movable arms is shown in Figures 15A-15D. As shown in Figure 15A, in a pre-administration state, the oral drug dosage form 1500 includes a body 1502 that forms two opposing outer portions of the drug dosage form, with the formation of a first movable arm 1504 and a second movable arm 1506 visible in the figure. As shown in Figure 15A, the body includes a first set of fluid inlets 1508, a second set of fluid inlets 1510, a first axis, and a second axis 1514. Figure 15B shows a post-administration state in which the movable arms 1504, 1506, 1516, and 1518 begin to extend away from the body 1502 of the oral drug dosage form 1500. After administration, the first set of fluid inlets allows gastrointestinal fluids to enter a swellable material section 1520 that contains a swellable material. The third movable arm 1516 includes a ladder-shaped feature 1522 that sits within a directional channel 1524; as the swellable material expands, the ladder-shaped feature 1522 is pushed through the directional channel, extending the movable arm 1516, until it reaches a stop 1526. The first movable arm 1504 operates using this type of mechanism, with both the first movable arm 1504 and the second movable arm 1516 rotating on a shared axis. The second movable arm 1506 and the fourth movable arm 1518 operate using this type of mechanism, rotating on the second axis 1514. FIG. 15C shows a post-dosage state of the oral drug dosage form 1500 with the movable arms fully extended. A component view of an embodiment of the oral drug dosage form 1500 is shown in FIG. 15D. In some embodiments, the components of oral drug dosage form 1500 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form pre-administered oral drug dosage form 1500. For example, in some embodiments, the body (or one or more portions thereof) is produced independently from the first movable arm and the second movable arm, and then such components are assembled to form the oral drug dosage form.

[0083] An exemplary dosage form 2100 having four movable arms is shown in Figures 21A-21C. The pre-dosage state of the oral drug dosage form 2100 is shown in Figure 21A, where the oral drug dosage form 2100 includes a body 2102 having an expandable material section 2104 configured to contain at least a portion of an expandable material 2110. As with other teachings provided herein for oral drug dosage forms having a swellable material, in certain aspects, the expandable material can be used as a mechanism to change the oral drug dosage form from a pre-dosage state to a post-dosage state. In this embodiment, the body 2102 includes an orifice 2106 operably connected to the expandable material section 2104, and upon swelling, the expandable material 2110 may extend outwardly from and beyond the orifice 2106 (or at least to a greater extent if the expandable material is already protruding through the orifice). The expandable material 2110 may be configured in conjunction with non-expandable features to maintain a particular shape of at least a portion of the expandable material and / or to contact contact elements of one or more movable arms, etc. As shown in FIG. 21A, the expandable material is embedded in non-expandable features that encapsulate the expandable material in a pre-dosed state (as shown in FIG. 21C below, non-expandable features 2128 expand with the expandable material 2110 and contact each of the movable arms). The body of the oral drug dosage form 2100 includes a cap 2112. The oral drug dosage form 2100 includes four movable arms (the view in FIG. 21A shows three of the movable arms 2114, 2116, 2118), each configured such that at least a portion of each movable arm is extendable beyond or further from the body of the oral drug dosage form 2100 via force provided by the expandable material 2110. Specifically, each movable arm is configured to rotate on an axis. For example, the first movable arm 2114 is configured to rotate on a first axis 2124. As shown in the pre-dosing state shown in FIG. 21A, the oral drug dosage form 2100 may further include an erodible restraint 2122 configured to prevent extension of the movable arm in the pre-dosing state.A cross-sectional view of oral drug dosage form 2100 is shown in FIG. 21B, where expandable material 2110 expands (at least partially) through or past orifice 2106 in body 2102 to apply a force to each movable arm such that each movable arm moves to an extended position. FIG. 21C shows a top view of oral drug dosage form 2100 in a post-dosage state, with first movable arm 2114, second movable arm 2116, third movable arm 2118, and fourth movable arm 2120 shown in an extended position. In some embodiments, the post-dosage state forms a design shape provided by the expandable material and / or non-expandable features. In some embodiments, components of oral drug dosage form 2100 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form oral drug dosage form 2100 pre-administered. For example, in some embodiments, the body (or one or more portions thereof) is generated independently from each movable arm, and then such components are assembled to form the oral drug dosage form.

[0084] An exemplary dosage form 2200 having movable arms is shown in Figures 22A-22B. In Figure 22A, the oral drug dosage form 2200 includes movable arms 2114, 2116. Specifically, each movable arm is configured to rotate on an axis. For example, the first movable arm 2114 is configured to rotate on a first axis 2224, and the second movable arm 2116 is configured to rotate on a second axis 2226, and the oral drug dosage form 2200 includes a body 2202 having an expandable material section 2204 configured to contain at least a portion of the expandable material 2210.

[0085] 22A , expandable material section 2204 contains expandable material 2210 and piston 2211, where the piston has a certain stiffness. In a pre-dosing state, piston 2211 is located within expandable material section 2204. In a post-dosing state, expandable material 2210 absorbs liquid (e.g., gastric or intestinal fluids) and increases in volume, pushing piston 2211 to move toward movable arms 2114, 2116. Body 2202 includes orifice 2206 operably connected to expandable material section 2204, whereupon piston 2211 may extend outwardly from and beyond orifice 2206 upon expansion of the swellable material in the presence of gastrointestinal fluids. 22B , the body of drug dosage form 2200 includes body 2202, which includes cap 2212 and base 2201, with movable arms 2214, 2216 connected to cap 2212 by pivot 2226, and one or more fluid inlets 2203 operably located within base 2201. In some embodiments, fluid inlets 2203 can be filled with a soluble material. When the drug dosage form comes into contact with water, the soluble material begins to dissolve and the fluid inlets connect with expandable material section 2204. Each movable arm extensibly rotates about the body, which is the main body of oral drug dosage form 2200, via force provided by expandable material 2210. In some embodiments, expandable material 2210 is pre-formed. After absorbing water, expandable material 2210 expands according to a preset shape until a portion of expandable material 2210 protrudes from orifice 2206 and pushes movable arm 2214 to rotate. The expandable material moves toward the orifice until it is blocked by cap 2212. A cross-sectional view of oral drug dosage form 2200 is shown in FIG. 22B. In some embodiments, components of oral drug dosage form 2200 may be produced, for example, via three-dimensional printing, injection molding, ultrasonic welding, or any combination thereof, and then assembled to form oral drug dosage form 2200 pre-administered. For example, in some embodiments, the body (or one or more portions thereof) is produced independently from each movable arm, and then such components are assembled to form the oral drug dosage form. B. Components of Oral Drug Dosage Forms and Their Materials

[0086] In certain aspects, provided herein are components of oral drug dosage forms such as swellable and / or expandable materials, as well as associated non-swellable features including swelling structures, one or more movable arms, bodies and features formed therein, drugs, and erodible restraints.

[0087] The drug dosage forms described herein contain one or more features that generate a force that contributes (in whole or in part) to the change of the pre-administration state of the drug dosage form to the post-administration state. In some embodiments, the oral drug dosage form comprises a swellable material and / or an expanding material. The swellable materials described herein are configured to expand in the presence of gastrointestinal fluids to generate a force applied to one or more movable arms or a feature associated with the swellable material (e.g., a non-swelling feature covering at least a portion of the swellable material, including a non-swelling feature comprising a semi-permeable material), such that the oral drug dosage form transitions to a stretched dosage form. In some embodiments, the oral drug dosage form comprises a single unit of a swellable material. In some embodiments, the oral drug dosage form comprises two or more separate units of one or more swellable materials (e.g., a first swellable material in a first swellable material section and a second swellable material in a second swellable material section). In embodiments having two or more separate units of one or more swellable materials, the swellable materials of the separate units can be the same or different.

[0088] In some embodiments, the swellable and / or expandable material is configured to expand at a desired rate and / or with a desired force. For example, in some embodiments, the swellable and / or expandable material is configured to rapidly expand upon contact with gastrointestinal fluid (including contact of the oral drug dosage form with gastrointestinal fluid) to prevent the oral drug dosage form from passing through the stomach before remaining in the stomach for a desired gastric retention period. In some embodiments, the swellable and / or expandable material is configured to expand with a force required to move components of the oral drug dosage form into a gastric retention state, e.g., to move one or more movable arms.

[0089] In some embodiments, the swellable material expands in volume by at least about 1.2 times after exposure to gastrointestinal fluid, e.g., at least about 1.3 times, 1.4 times, 1.5 times, 1.6 times, 1.7 times, 1.8 times, 1.9 times, or 2.0 times. In some embodiments, the expansion occurs within about 1 hour, e.g., within about 50 minutes, 40 minutes, 30 minutes, 20 minutes, 10 minutes, or 5 minutes. In some embodiments, the swellable material expands in volume by at least about 1.2 times in 30 minutes after exposure to gastrointestinal fluid, e.g., at least about 1.3 times in 30 minutes, 1.4 times in 30 minutes, 1.5 times in 30 minutes, 1.6 times in 30 minutes, 1.7 times in 30 minutes, 1.8 times in 30 minutes, 1.9 times in 30 minutes, or 2.0 times in 30 minutes. In some embodiments, the swellable material reaches a substantially fully swollen state (e.g., absorbs at least about 90% of its fluid volume) within about 1 hour, e.g., within any of about 50 minutes, 40 minutes, 30 minutes, 20 minutes, 10 minutes, or 5 minutes.

[0090] In some embodiments, the swellable material, upon swelling, at least partially conforms to the shape of the directional channel and / or orifice, or a portion thereof. In some embodiments, the swellable material, upon swelling, at least partially assumes a predetermined shape and / or size. In some embodiments, the predetermined shape and / or size is guided, at least in part, by a non-swelling characteristic associated with the swellable material, such as a non-swelling material surrounding at least a portion of the swellable material in a pre-administered state. In some embodiments, the general shape of the swellable material after swelling differs from the shape of the swellable component before swelling. In some embodiments, the swellable material includes a coating. In some embodiments, the coating of the swellable material delays swelling of the swellable material for at least a predetermined time after administration of the oral drug dosage form to an individual, e.g., by preventing contact with gastrointestinal fluids and / or inhibiting swelling. In some embodiments, the coating completely surrounds the swellable material. In some embodiments, the coating partially surrounds the swellable material. In some embodiments, the swellable material is completely or partially surrounded by a semi-permeable material.

[0091] In some embodiments, the swellable material comprises sodium alginate (SA), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), hydroxypropyl methylcellulose (HPMC), polyethylene oxide (PEO), polyvinyl alcohol (PVA), microcrystalline cellulose (MCC), croscarmellose sodium (CCNa), carboxymethyl cellulose sodium (CMC-Na), polyvinylpolypyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), polyethylene glycol (PEG), or a mixture thereof. In some embodiments, the HPC comprises L-HPC or H-HPC, or a combination thereof.

[0092] In some embodiments, the swellable material comprises a material selected from the group consisting of crosslinked products and shape memory materials. In some embodiments, the swellable material comprises a material selected from the group consisting of polyethylene oxide-polyethylene glycol (PEO-PEG) crosslinked polymers, polycaprolactone-polyethylene glycol-polycaprolactone (PCL-PEG-PCL), hydroxypropyl cellulose, polyethylene oxide (PEO) such as high molecular weight PEO, sodium alginate, carbomer, high molecular weight hydroxypropyl cellulose (HPC), high molecular weight hydroxypropyl methylcellulose or hypromellose (HPMC), methylcellulose (MC), polymeric polyvinyl alcohol (PVA), polyvinyl acetate (PVAc) and polyvinylpyrrolidone (PVP) 80 / 20, methacrylic acid ester copolymers, ammonioalkyl methacrylate copolymers, aminoalkyl methacrylate copolymer E, hydroxypropyl methylcellulose acetate succinate or hypromellose acetate succinate (HPMCAS), hydroxypropyl methylcellulose phthalate (HPMCP), or combinations thereof.In some embodiments, the shape memory material is polyurethane, a block copolymer of polyethylene terephthalate (PET) and polyethylene oxide (PEO), a block copolymer containing polystyrene and poly(1,4-butadiene), an ABA triblock copolymer made from poly(2-methyl-2-oxazoline) and polytetrahydrofuran, polynorbornene (Norsolex, CdF Chemie / Nippon developed by Zeon), polynorbornene with partially substituted polyhedral oligosilsesquioxane (POSS), copolymers consisting of polycyclooctene (PCOE) and poly(5-norbornene-exo,exo-2,3-dicarboxylic anhydride) (PNBEDCA), poly(ester-urethane), composites of polyol (soft segment) and chain extender (hard phase) (diisocyanate bound to poly(ε-caprolactone) (PCL), poly(ethylene adipate) (PEA) glycol), combinations of poly(ester-urethane) (PUR) and PCL, ethylene oxide-ethylene terephthalate segmented copolymers, oligo(ε-caprolactone)- and oligo(p-dicarboxylic acid) The material may be selected from the group consisting of poly(oxanone)-based PUR, poly(p-dioxanone)-b-poly(tetramethylene oxide glycol) multiblock copolymers, poly(methyl methacrylate)-poly(ethylene glycol) (PMMA-PEG) semi-interpenetrating polymer networks (IPNs), poly(cyclohexyl methacrylate) (PCHMA) backbones crosslinked with bifunctional PCL polymers, polymers with grafted short PEG side chains on a PCL backbone, Nafion®, copoly(ester-urethane) networks, covalently crosslinked poly[ethylene-co-(vinyl acetate)] (cPEVA), a combination of PCL and poly(tetramethylene ether) glycol (PTMEG), or combinations thereof. In some embodiments, the material, including the swellable material and the shape memory material, may have multiple properties.

[0093] In some embodiments, the swellable material further comprises a salt or mixture of salts, for example, to facilitate absorption of gastrointestinal fluids and promote swelling. In some embodiments, the salt is selected from the group consisting of sodium salts, magnesium salts, and potassium salts. In some embodiments, the sodium salt is Na2SO4.

[0094] In some embodiments, the swellable material further comprises a gas generating substance, for example, by producing carbon dioxide upon contact with gastrointestinal fluids, and in some embodiments, the gas generating substance is selected from carbonates, bicarbonates, or combinations thereof.

[0095] In some embodiments, the expandable material comprises a material selected from the group consisting of poly(vinyl acetate) (PVAc), polyvidone, hydroxypropyl methylcellulose phthalate, methacrylic acid copolymer, ethyl cellulose (EC), hydroxypropyl methylcellulose (HPMC), tocopherol polyethylene glycol succinate (TPGS), polycaprolactone (PCL), polyethylene (PE), guar, polyether ether ketone (PEEK), polyphenylsulfone (PPSU), polysulfone (PSU), polypropylene (PP), ethylene vinyl acetate (EVA), polymethyl methacrylate (PMMA), polylactic acid (PLA), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) (PLGA), or a combination thereof.

[0096] In some embodiments, the swellable material does not contain a drug.

[0097] In some embodiments, the swellable material in the swellable material compartment is in an amount of at least about 5 mg, e.g., at least about any of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 75 mg, 100 mg, 125 mg, 150 mg, 175 mg, or 200 mg.

[0098] In some embodiments, the swellable material is about 10 mm 3 ~approx. 50mm 3In some embodiments, the swellable material has a swelling volume of at least about 5 mm 3 , e.g., at least about 10 mm 3 , 15mm 3 , 20mm 3 , 25mm 3 , 30mm 3 , 35mm 3 , 40mm 3 , 45mm 3 , or 50mm 3 The swelling volume of the swelled film is either

[0099] In some embodiments, the swellable material can be printed via a three-dimensional printing process, injection molding, ultrasonic welding, or any combination thereof, as described in other aspects of the present disclosure. In some embodiments, the swellable material is a thermoforming material.

[0100] In some embodiments, the body includes two or more parts configured to form the body. In some embodiments, the body includes one or more bases and one or more caps. In some embodiments, the body includes two or more materials. In some embodiments, the body of the oral drug dosage form is a monolithic structure. In some embodiments, the body defines the outer boundary of the oral drug dosage form in a pre-administered state. In some embodiments, the body can be printed via a three-dimensional printing process, injection molding, ultrasonic welding, or any combination thereof, as described in other aspects of the present disclosure. In some embodiments, the body is constructed of a thermoformable material.

[0101] In some embodiments, the body includes one or more swellable material sections, for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 swellable material sections. In some embodiments, the swellable material sections are configured to substantially contain the swellable material of the oral drug dosage form in a pre-administration state. In some embodiments, the swellable material sections and the contact element of the movable arm substantially surround the swellable material of the oral drug dosage form in a pre-administration state. The swellable material sections may be of any size and / or shape.

[0102] In some embodiments, the body includes one or more directional channels and / or orifices. In some embodiments, the directional channels are configured to direct the movement of the movable arms via forces provided by the swellable material. The directional channels and / or orifices may be any shape and / or size, and as taught herein, such shape and / or size may be guided by other design features of the oral drug dosage form, such as the mechanism and shape of the movable arms and the amount of swellable material required to achieve a post-administration state for gastric retention. In some embodiments, the directional channels include curved channels. In some embodiments, the directional channels include circular channels. In some embodiments, the directional channels include square or rectangular channels. In some embodiments, the orifices are square, circular, or rectangular.

[0103] In some embodiments, the directional channel further comprises one or more fluid inlets (as described below) configured to further expose the swellable material to gastrointestinal fluids during the swelling process.

[0104] In some embodiments, the body includes one or more fluid inlets, such as anywhere from about 5 to about 20 per swellable material compartment, and the one or more fluid inlets are operably connected to the swellable material compartments. In some embodiments, at least one of the one or more fluid inlets includes a semipermeable material. In some embodiments, at least one of the one or more fluid inlets is a semipermeable material that fills pores formed by the body. In some embodiments, the one or more fluid inlets is a semipermeable membrane that at least partially wraps around the swellable material. In some embodiments, at least one of the one or more fluid inlets is a pore. In some embodiments, the one or more fluid inlets is a pore having a maximum transverse dimension (e.g., diameter) of about 0.5 to about 1 mm. The pore may be any shape, including circular, square, or rectangular.

[0105] In some embodiments, the body further forms a stop configured to engage the movable arm in the extended position. The stop may be any part of the body and need not have a particular design. In some embodiments, the stop includes a locking element configured to maintain the movable arm in one or more extended positions.

[0106] As described herein, the oral drug dosage form includes one or more movable arms, for example, one, two, three, four, five, six, seven, eight, or ten movable arms. The movable arms may be designed using multiple mechanisms based on the swelling of a swellable material, and the oral drug dosage form may implement one or more such mechanisms. In some embodiments, the movable arm, or a portion thereof, is configured to slide within a directional channel. In some embodiments, a contact element of the movable arm is configured to slide within a directional channel. In some embodiments, the movable arm is configured to rotate on an axis. In some embodiments, at least two of the movable arms or the oral drug dosage form have different movement mechanisms. In some embodiments, at least two of the movable arms of the oral drug dosage form have the same movement mechanism. In some embodiments, at least two of the movable arms of the oral drug dosage form are configured such that at least a portion of each of the movable arms is extendable beyond or further away from the body of the oral drug dosage form via a force provided by the swellable material. In some embodiments, one or more movable arms are associated with a single swellable material in the swellable material compartment. For example, the swellable material in the swellable material compartment swells to cause actuation of one or more movable arms, hi some embodiments, the oral drug dosage form comprises two movable arms, a first movable arm associated with a first swellable material in the first swellable material compartment and a second movable arm associated with a second swellable material in the second swellable material compartment.

[0107] In some embodiments, the oral drug dosage form further comprises an erodible restraint configured to prevent extension of one or more movable arms for a sustained period of time. Generally speaking, the erodible restraint is configured to facilitate oral administration of the oral drug dosage form, for example, by preventing premature extension of one or more movable arms prior to entry into the individual's stomach. In some embodiments, the erodible restraint erodes within about 30 minutes, e.g., within about any of 25 minutes, 20 minutes, 15 minutes, 10 minutes, or 5 minutes, after administration to the individual.

[0108] In some embodiments, certain components of the oral drug dosage form, such as the body or the movable arm, comprise an insoluble material, a pH-sensitive eroding material such as a material that does not erode at stomach pH, ​​a slowly eroding material such as a material that erodes after the oral drug dosage form or its component leaves the stomach, or a combination thereof. In some embodiments, certain components such as the body or the movable arms comprise a material selected from the group consisting of ammonio methacrylate copolymer, ammonio-methacrylate copolymer type B, stearic acid, ethyl cellulose (EC), titanium dioxide, cellulose acetate phthalate (CAP), poly(lactide-co-glycolide) (PLGA), ethylene-vinyl acetate copolymer, polyethylene (PE), polycaprolactone (PCL), polylactic acid (PLA), cellulose acetate butyrate (CAB), cellulose acetate (CA), polyvinyl acetate (PVAc), polyvinyl acetal diethylaminolactate (AEA), poly(butyl methacrylate-co-(2-dimethylaminoethyl) methacrylate-co-methyl methacrylate), and poly(ethyl acrylate, methyl methacrylate, trimethylaminoethyl methacrylate chloride), or a combination thereof.

[0109] In some embodiments, the material of a component of the drug dosage form, such as the body or the movable arm, is a thermoplastic material. In some embodiments, the thermoplastic material is a thermoplastic polymer. In some embodiments, the thermoplastic material comprises any one or more of a plasticizer and other additives, such as a filler, a binder, a lubricant, a glidant, and a disintegrant. In some embodiments, the additive is selected from the group consisting of clay, SiC nanoparticles, Ni powder, carbon nanotubes, carbon fiber, carbon black, graphene, metal oxides (e.g., Fe3O4, TiO2, ZnO), silver (Ag) nanoparticles, gold (Au) nanoparticles, silver and gold nanoparticles, nanorods, nanowhiskers, nanowires, and cellulose nanocrystals.

[0110] In some embodiments, the body is configured to have a wall thickness (e.g., from the swellable material compartment to the exterior of the oral drug dosage form, or from the directional channel to the exterior of the oral drug dosage form) of at least about 0.3 mm, e.g., at least about 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, or 2.5 mm. In some embodiments, the body is configured to have a wall thickness (e.g., from the swellable material compartment to the exterior of the oral drug dosage form, or from the directional channel to the exterior of the oral drug dosage form) of between about 0.3 mm and about 2.5 mm, e.g., between about 0.5 mm and about 2.2 mm, or between about 0.4 mm and about 1.2 mm.

[0111] In some embodiments, the arms are configured to have a thickness of about 1 mm to about 2 mm, for example, about 1.1 mm to about 1.6 mm.

[0112] In some embodiments, the oral drug dosage form includes a component, such as a plunger or piston, configured to be pushed into one or more arms by a swellable material. In some embodiments, the column has a wall thickness of about 0.3 mm to about 2.5 mm, e.g., about 0.4 mm to about 2.2 mm. In some embodiments, the column has a wall thickness of at least about 0.3 mm, e.g., at least about any of 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, or 2.5 mm. C. Integration of One or More Drugs and Drug Release Profiles in Oral Drug Dosage Forms

[0113] The oral drug dosage forms described herein contain one or more drugs. In some embodiments, the oral drug dosage forms contain drugs with separate portions of the drug formulated and configured with substantially identical or different release profiles. In some embodiments, the oral drug dosage forms contain two or more drugs, for example, three, four, or five drugs. The drug or drugs in the oral drug dosage form can be released at any time during the life cycle of the oral drug dosage form. For example, in some embodiments, the oral drug dosage forms are configured and formulated to release the drug in an individual's stomach. In some embodiments, substantially all of the drug in the oral drug dosage form, for example, at least 70%, 75%, 80%, 85%, 90%, 95%, or 100%, is released in the stomach. In some embodiments, the oral drug dosage forms are configured to release the drug before or during swelling of the swellable material, such as an immediate release profile. In some embodiments, the drug dosage forms are configured to release the drug after leaving the stomach.

[0114] In some embodiments, the drug is a poorly soluble drug. In some embodiments, the poorly soluble drug is a Biopharmaceutics Classification System (BCS) Class II active pharmaceutical ingredient (API), e.g., a drug with high permeability and low solubility. In some embodiments, the poorly soluble drug is a Biopharmaceutics Classification System (BCS) Class IV active pharmaceutical ingredient (API), e.g., a drug with low permeability and low solubility. In some embodiments, the drug is a Biopharmaceutics Classification System (BCS) Class III active pharmaceutical ingredient (API), e.g., a drug with low permeability and high solubility. In some embodiments, the drug is selected from the group consisting of ribonuclease, aceclofenac, bicalutamide, carbamazepine, carvedilol, clotrimazole, cinnarizine, danazol, dapsone, estradiol, ethiofen glibenclamide, fenofibrate, griseofulvin, ibuprofen, itraconazole, ketoconazole, mefenamic acid, naproxen, nevirapine, nifedipine, nitrofurantoin, nomegestrol acetate, phenytoin sodium salt, piroxicam, praziquantel, rifampicin, sulfamethoxazole, trimethoprim, and verapamil hydrochloride.

[0115] Oral drug dosage forms may be configured to release drugs according to any desired release profile and to extend the release of two or more drugs, each with any desired release profile. Generally, the oral drug dosage forms described herein are designed for extended gastric retention, and therefore the release profile of at least one drug is configured based on the expected gastric retention of the oral drug dosage form. In some embodiments, when two or more drugs are in an oral drug dosage form, the oral drug dosage form is configured to release each drug according to a desired release profile. In some embodiments, the oral drug dosage form is configured so that all (or substantially all, e.g., at least about 90%) of the drug content in the oral drug dosage form (or a portion thereof) is released during the expected gastric retention of the oral drug dosage form. In some embodiments, the oral drug dosage form is configured so that a certain amount of the drug content in the oral drug dosage form (e.g., the second drug) is released after the oral drug dosage form or a component thereof is expected to be released from the stomach. In some embodiments, the oral drug dosage form is formulated and configured to release the drug according to a delayed release profile, a sustained release profile, a delayed sustained release profile, a zero order release profile, a first order release profile, an immediate release profile plus a sustained release profile, an immediate release profile plus a delayed release profile, an immediate release profile plus a delayed sustained release profile, a pulsed release profile, a repeated pulsed release profile, an immediate release profile plus a pulsed release profile, or a combination thereof.

[0116] The oral drug dosage forms described herein may be configured and formulated using various techniques to release a drug according to a desired drug release profile. In some embodiments, drug release from the oral drug dosage form is based on erosion of the drug-containing material, such as when the drug-containing material is exposed to gastrointestinal fluid. In some embodiments, the drug-containing material is configured as a layer with a predetermined surface area, such as the surface area exposed to gastrointestinal fluid, thickness, and drug mass fraction, and these properties of the drug-containing material provide the desired drug release. In some embodiments, the drug-containing material is in the form of a multilayer structure. In some embodiments, the drug-containing material is embedded (including partially embedded) in the material of a component of the drug dosage form. The design, configuration, and materials of such drug-containing materials to provide the desired drug release are known in the art; see, for example, U.S. Pat. No. 10,350,822, incorporated herein in its entirety.

[0117] In some embodiments, the oral drug dosage form is comprised of a drug-containing compartment, the compartment having an orifice through which the drug is released from the oral drug dosage form. In some embodiments, the orifice is blocked with an erodible material, such as a plug. In some embodiments, the feature blocking the orifice so that the drug is retained in the compartment of the oral drug dosage form is configured to no longer block the orifice at a desired time. For example, in some embodiments, the drug-containing compartment is sealed with an erodible plug, which dissolves at a specific time after administration to an individual, thereby releasing the drug from the oral drug dosage form. The timing of release can be based, for example, on the thickness and / or material of the plug. The drug-containing compartment can be comprised of any component. In some embodiments, the oral drug dosage form includes multiple drug-containing compartments. In some embodiments, the component is a non-erodible material, such as an insoluble shell material. In some embodiments, the component erodes after the drug leaves the drug-containing compartment, e.g., after the oral drug dosage form leaves the stomach.

[0118] In some embodiments, the oral drug dosage form is configured so that the drug leaches or diffuses from the material.

[0119] In some embodiments, a drug is loaded into one or more of the movable arms. In some embodiments, each movable arm is loaded with a drug. In some embodiments, a drug is loaded into one or more of the caps. In some embodiments, a drug is loaded into the swellable material section.

[0120] The drug or drugs of the drug dosage forms described herein may be part of any of the components described herein. In some embodiments, the drug is not loaded into the swellable material. In some embodiments, the swellable material does not contain a drug. D. Characterization of Oral Drug Dosage Forms in the Post-Administration State to Provide Gastric Retention

[0121] As described herein, swelling of one or more swellable materials or portions thereof increases the size(s) of the oral drug dosage form, thereby allowing the drug to be retained in the stomach for an extended period of time. In some embodiments, the post-administration state of the oral drug dosage form is referred to as the gastric retention state. Those skilled in the art will readily understand that characteristics of an oral drug dosage form, such as size during swelling of a swellable material or portion thereof, are dynamic and may change over time. The description of a specific state of an oral drug dosage form, such as the gastric retention state after administration, is not intended to limit the disclosure herein to only one static embodiment of the drug dosage form.

[0122] In some embodiments, when the oral drug dosage form is in an expanded state (e.g., a gastric retention state), the oral drug dosage form is sized to block and / or prevent passage of the oral drug dosage form through an aspect of the pylorus (such as the pyloric antrum, the pyloric canal, or the pyloric orifice formed by the pyloric sphincter) into the duodenum. In some embodiments, when the oral drug dosage form is in an expanded state, the oral drug dosage form is sized to block and / or prevent passage of the oral drug dosage form through the pyloric orifice formed by the pyloric sphincter. In some embodiments, when the oral drug dosage form is in an expanded state, at least two vertical dimensions of the oral drug dosage form are each independently at least about 20 mm to about 70 mm in length, e.g., at least about 20 mm to about 50 mm in length, about 30 mm to about 60 mm in length, or about 40 mm to about 70 mm in length. In some embodiments, when the oral drug dosage form is in an expanded state, at least two vertical dimensions of the drug dosage form are each independently at least about 20 mm in length, e.g., at least about 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, or 70 mm in length. In some embodiments, when the oral drug dosage form is in an expanded state, at least two vertical dimensions of the drug dosage form are each independently at least about 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, or 70 mm in length. In some embodiments, when the oral drug dosage form is in an expanded state, one dimension of the at least two vertical dimensions is different from another dimension. In some embodiments, when the oral drug dosage form is in an expanded state, one dimension of the at least two vertical dimensions is the same as another dimension. It should be noted that individuals may have different anatomical characteristics and sizes (e.g., adults versus children), and the present application encompasses oral drug dosage forms designed with such considerations in mind to achieve desired gastric retention.

[0123] The oral drug dosage forms described herein are configured to be retained in the stomach for a longer period of time than drug dosage forms that do not have a gastric retention mechanism (e.g., oral drug dosage forms that pass through the stomach following the natural flow of ingested material out of the stomach). In some embodiments, the oral drug dosage form is configured to be retained in the stomach for about 8 hours to about 3 months, e.g., about 8 hours to about 24 hours, about 8 hours to about 36 hours, about 18 hours to about 30 hours, about 20 hours to about 28 hours, about 12 hours to about 36 hours, about 1 day to about 3 days, about 3 days to about 7 days, about 8 hours to about 1 month, or about 8 hours to about 2 months. In some embodiments, the oral drug dosage form is configured to be retained in the stomach for at least about 8 hours, e.g., at least about 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, or 36 hours. In some embodiments, the oral drug dosage form is configured to be retained in the stomach for at least about 1 day, e.g., at least about 2, 3, 4, 5, 6, 7, 14, 21 days, 1 month, 1.5 months, 2 months, 2.5 months, or 3 months. In some embodiments, the oral drug dosage form is configured to be retained in the stomach for about 7 days or less, e.g., about any of 6 days, 5 days, 4 days, 3 days, 2 days, 36 hours, 30 hours, 24 hours, 18 hours, or 12 hours or less. In some embodiments, the oral drug dosage form is configured to be retained in the stomach for about 3 months or less, e.g., about any of 2.5 months, 2 months, 1.5 months, 1 month, 21 days, 14 days, or 7 days or less.In some embodiments, the oral drug dosage form is configured to be retained in the stomach for any of about 8 hours, 9 hours, 10 hours, 11 hours, 12 hours, 13 hours, 14 hours, 15 hours, 16 hours, 17 hours, 18 hours, 19 hours, 20 hours, 21 hours, 22 hours, 23 hours, 24 hours, 25 hours, 26 hours, 27 hours, 28 hours, 29 hours, 30 hours, 31 hours, 32 hours, 33 hours, 34 hours, 35 hours, 36 hours, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days, 21 days, 1 month, 1.5 months, 2 months, 2.5 months, or 3 months.

[0124] In some embodiments, the post-administration state of the oral drug dosage form occurs within about 1 hour after administration of the oral drug dosage form to an individual. For example, in some embodiments, the oral drug dosage form achieves a post-administration gastric retention state within about 1 hour, 50 minutes, 40 minutes, 30 minutes, 20 minutes, 10 minutes, or 5 minutes after administration to an individual.

[0125] In some embodiments, the oral drug dosage form is configured to allow the oral drug dosage form, or portions thereof, to pass through the pylorus and exit the stomach. For example, in some embodiments, one or more components of the oral drug dosage form, such as one or more movable arms, erode and / or soften in the stomach, thereby allowing them to leave the stomach in one or more portions. In some embodiments, the oral drug dosage form is configured to soften after a gastric retention period and pass through the pylorus as a whole. In some embodiments, the erosion or dissolution of components of the oral drug dosage form, or portions thereof, results from prolonged exposure to gastrointestinal fluids in the stomach (e.g., due to prolonged exposure to low pH). E. Characteristics of Oral Drug Dosage Forms in the Pre-Administration State

[0126] The oral drug dosage forms described herein may be formed in any number of shapes, sizes, weights, and appearances. As described herein, the oral drug dosage forms of the present application may take on forms with different characteristics (such as size and shape) during the life cycle of the administered oral drug dosage form (e.g., the administration state and the post-administration gastric retention state).

[0127] In some embodiments, the oral drug dosage forms described herein are suitable for oral administration to human individuals.Such oral drug dosage forms of the present application can be of any size, shape, or weight suitable for oral administration to a particular human individual, such as, for example, children and adults.In some embodiments, the oral drug dosage form is suitable for oral administration to an individual, and the size, shape, or weight of the drug dosage form is selected based on one or more of the individual's attributes, such as height, weight, age, or size of anatomical features, such as those related to oral administration.

[0128] In some embodiments, the exterior surface of the oral drug dosage form, e.g., the surface of the body, has the shape of a capsule, a circle, an oval, a bullet, an arrowhead, a triangle, an arcuate triangle, a square, an arcuate square, a rectangle, an arcuate rectangle, a diamond, a pentagon, a hexagon, an octagon, a half moon, an almond, or a combination thereof.

[0129] In some embodiments, the oral drug dosage form has a maximum transverse dimension of about 5 mm to about 26 mm, e.g., about 5 mm to about 15 mm, about 6 mm to about 13 mm, or about 7 mm to about 11 mm. In some embodiments, the oral drug dosage form has a maximum transverse dimension of at least about 5 mm, e.g., at least about 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, or 24 mm. In some embodiments, the drug dosage form has a maximum transverse dimension of less than about 26 mm, e.g., less than about any of 25 mm, 24 mm, 23 mm, 22 mm, 21 mm, 20 mm, 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, or 5 mm. In some embodiments, the drug dosage form has a maximum transverse dimension of less than about any of 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 20.5 mm, 21 mm, 21.5 mm, 22 mm, 22.5 mm, 23 mm, 23.5 mm, or 24 mm. In some embodiments, the maximum transverse dimension is measured across a surface, e.g., an outer surface, of the drug dosage form (e.g., represented by the length or width of the oral drug dosage form). In some embodiments, the maximum transverse dimension is measured across or diagonally across the oral drug dosage form.

[0130] In some embodiments, the oral drug dosage form has a transverse dimension perpendicular to the largest transverse dimension of about 5 mm to about 20 mm, e.g., about 5 mm to about 15 mm, about 6 mm to about 13 mm, or about 7 mm to about 11 mm. In some embodiments, the oral drug dosage form has a transverse dimension perpendicular to the largest transverse dimension of at least about 5 mm, e.g., at least about 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm. In some embodiments, the oral drug dosage form has a transverse dimension perpendicular to the largest transverse dimension of less than about 20 mm, e.g., less than about 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, or 5 mm. In some embodiments, the oral drug dosage form has a transverse dimension perpendicular to the largest transverse dimension of about 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm. In some embodiments, the transverse dimension perpendicular to the largest transverse dimension is measured across the surface of the oral drug dosage form. In some embodiments, the transverse dimension perpendicular to the largest transverse dimension is measured across or diagonally across the oral drug dosage form.

[0131] In some embodiments, the oral drug dosage form has a thickness of about 5 mm to about 20 mm, e.g., about 5 mm to about 15 mm, about 6 mm to about 13 mm, or about 7 mm to about 11 mm. In some embodiments, the oral drug dosage form has a thickness of at least about 5 mm, e.g., at least about 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm. In some embodiments, the oral drug dosage form has a thickness of less than about 20 mm, e.g., less than about 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, or 5 mm. In some embodiments, the oral drug dosage form has a thickness of about any of 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm.

[0132] In some embodiments, the oral drug dosage form has a total weight of about 50 mg to about 1,000 mg, e.g., about 50 mg to about 100 mg, about 100 to about 200 mg, about 200 mg to about 300 mg, about 300 mg to about 400 mg, about 400 mg to about 500 mg, about 500 mg to about 600 mg, about 600 mg to about 700 mg, about 700 mg to about 800 mg, about 800 mg to about 900 mg, or about 900 mg to about 1,000 mg. In some embodiments, the oral drug dosage form has a total weight of at least about 50 mg, e.g., at least about any of 75 mg, 100 mg, 125 mg, 150 mg, 175 mg, 200 mg, 225 mg, 250 mg, 275 mg, 300 mg, 325 mg, 350 mg, 375 mg, 400 mg, 425 mg, 450 mg, 475 mg, 500 mg, 550 mg, 600 mg, 650 mg, 700 mg, 750 mg, 800 mg, 850 mg, 900 mg, 950 mg, or 1,000 mg. In some embodiments, the oral drug dosage form has a total weight of less than about 1,000 mg, e.g., less than any of about 950 mg, 900 mg, 850 mg, 800 mg, 750 mg, 700 mg, 650 mg, 600 mg, 550 mg, 500 mg, 475 mg, 450 mg, 425 mg, 400 mg, 375 mg, 350 mg, 325 mg, 300 mg, 275 mg, 250 mg, 225 mg, 200 mg, 175 mg, 150 mg, 125 mg, 100 mg, 75 mg, or 50 mg. In some embodiments, the oral drug dosage form has a total weight of about any of 50 mg, 75 mg, 100 mg, 125 mg, 150 mg, 175 mg, 200 mg, 225 mg, 250 mg, 275 mg, 300 mg, 325 mg, 350 mg, 375 mg, 400 mg, 425 mg, 450 mg, 475 mg, 500 mg, 550 mg, 600 mg, 650 mg, 700 mg, 750 mg, 800 mg, 850 mg, 900 mg, 950 mg, or 1,000 mg. F. Additional Features of Drug Dosage Forms

[0133] In some embodiments, the oral drug dosage form includes a gas-filled compartment, for example, to provide buoyancy to the oral drug dosage form. In some embodiments, the gas-filled compartment is embedded in a component of the oral drug dosage form, such as the body or one or more movable arms. In some embodiments, the gas-filled compartment has an erodible plug configured to release the gas-filled compartment at a time after administration of the oral drug dosage form to an individual.

[0134] In some embodiments, the oral drug dosage form includes additional features such as an outer coating, outer layer (e.g., capsule shell), or outer marking. In some embodiments, the outer coating or layer includes / is a flavor coating. In some embodiments, the outer coating or layer includes / is a sugar coating. In some embodiments, the outer coating or layer includes / is a cosmetic coating. In some embodiments, the outer coating or layer includes / is a color coating. In some embodiments, the outer coating or layer is a film coating. In some embodiments, the outer coating or layer is a polymer coating. In some embodiments, the outer coating completely surrounds the drug dosage form. In some embodiments, the outer layer forms part of the exterior of the oral drug dosage form. In some embodiments, the additional component is a label such as a drug logo, company name or abbreviation, graphic, drug label, drug chemical name or abbreviation, drug specification, identification barcode, or a combination thereof.

[0135] G. Exemplary Medical Devices The concepts of the present invention can be applied to medical devices. In some embodiments, a medical device for gastric retention is provided, the medical device comprising an expandable material. The movable arm is configured such that at least a portion of the movable arm may extend beyond or away from the oral drug dosage form due to a force provided by the expandable material, the body is an expandable material chamber configured to contain at least a portion of the expandable material and operably connected to the directional channel of the expandable material chamber, the movable arm including a contact element configured to approximate the directional channel with the expandable material, the expandable material chamber and the contact element of the movable arm substantially surrounding the expandable material, the movable arm or a portion thereof configured to slide in the directional channel such that the movable arm extends beyond the body of the medical device along an axis based on the directional channel about which the movable arm rotates, one or more fluid inlets, such as an orifice or semi-permeable material, operably connected to the expandable material chamber, and the drug, the medical device being configured to have a high-density morphology in a pre-acquisition state and a post-acquisition state having an expanded dosage form that provides gastric retention, the expanded dosage form in the post-administration state of the medical device being at least partially due to the material expanding in the presence of gastrointestinal fluid. In some embodiments, the body includes a matrix and a cap. In some embodiments, the swelling material comprises a plunger. H. Exemplary Oral Drug Dosage Forms

[0136] In some embodiments, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising: a swellable material; a movable arm configured such that at least a portion of the movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the swellable material; the body comprising a swellable material section configured to contain at least a portion of the swellable material; and a directional channel operatively connected to the swellable material section, the movable arm including a contact element configured to interact with the swellable material proximate the directional channel, the contact element of the swellable material section and the movable arm substantially surrounding the swellable material, and the movable arm or a portion thereof The oral drug dosage form includes a directional channel configured to slide within the directional channel such that the movable arm extends beyond or further from the body of the oral drug dosage form along an axis based on the directional channel; one or more fluid inlets, such as a semi-permeable material operably connected to the swellable material section; a movable arm including a stop or one or more stops configured to engage the movable arm in an extended position; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an extended dosage form that provides gastric retention, the extended dosage form of the oral drug dosage form in the post-administration state being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid. In some embodiments, the stop includes a locking element configured to maintain the movable arm in one or more extended positions. In some embodiments, the locking element is configured to maintain the movable arm in a single position. In some embodiments, the locking element is configured to maintain the movable arm in multiple advanced positions.

[0137] In some embodiments, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising a swellable material, and first and second movable arms, the first and second movable arms configured such that at least a portion of each movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the swellable material, the first and second movable arms extend in substantially opposite directions along an axis based on a directional channel, the body comprising a swellable material section configured to contain at least a portion of the swellable material, and first and second directional channels operatively connected to the swellable material sections, the first movable arm comprising a first contact element configured to interact with the swellable material in proximity to the first directional channel, the second movable arm comprising a second contact element configured to interact with the swellable material in proximity to the second directional channel, the swellable material section and the first contact element of the first movable arm and the second contact element of the second movable arm being a first directional channel and a second directional channel that substantially surround the swellable material, the first movable arm or a portion thereof configured to slide within the first directional channel such that the first movable arm extends beyond or further away from the body of the oral drug dosage form along an axis, and the second movable arm or a portion thereof configured to slide within the second directional channel such that the second movable arm extends beyond or further away from the body of the oral drug dosage form along an axis, and operable to the swellable material compartment; a first stop configured to engage the first movable arm in an extended position and a second stop configured to engage the second movable arm in an extended position; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention, the elongated dosage form of the oral drug dosage form in the post-administration state being due at least in part to expansion of a swellable material in the presence of gastrointestinal fluid.

[0138] In some embodiments, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising: a first swellable material; a first movable arm, wherein the first movable arm is configured such that at least a portion of the movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the first swellable material, the first movable arm configured to rotate on a first axis; a second swellable material; and a second movable arm, wherein the second movable arm extends beyond or away from a body of the oral drug dosage form via a force provided by the first swellable material. a first swellable material section configured to contain at least a portion of the first swellable material; and a first directional channel operably connected to the first swellable material section, the first directional channel comprising a curved channel; and a second movable arm configured to rotate on a second axis, the first swellable material section configured to contain at least a portion of the first swellable material, the first directional channel comprising a curved channel; and the first movable arm configured to interact with the first swellable material proximate to the first directional channel. a first directional channel configured to contain at least a portion of a second swellable material, the first swellable material section and the first contact element of the first movable arm substantially surrounding the first swellable material, the first movable arm or a portion thereof being configured to rotate on a first axis in a manner such that the first contact element slides within the first directional channel such that the first movable arm extends beyond or further away from the body of the oral drug dosage form, and one or more fluid inlets operatively connected to the first swellable material section and the second swellable material section. a second swellable material section configured to be curved; and a second directional channel operatively connected to the second swellable material section, the second directional channel comprising a curved channel, the second movable arm comprising a second contact element configured to interact with the second swellable material proximate to the second directional channel, the second swellable material section and the second contact element of the second movable arm substantially surrounding the second swellable material, and the second movable arm, or a portion thereof, extending beyond or away from the body of the oral drug dosage form.a second movable arm including a second directional channel configured to rotate on a second axis in a manner such that the second contact element slides within the second directional channel, and one or more fluid inlets operatively connected to the second swellable material section; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention, the elongated dosage form of the post-administration state of the oral drug dosage form being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid.

[0139] In some embodiments, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising a first swellable material and a first movable arm and a second movable arm, the first movable arm and the second movable arm configured such that at least a portion of each movable arm is extendable beyond or away from a body of the oral drug dosage form via a force provided by the first swellable material, the first movable arm and the second movable arm extending in substantially opposite directions along an axis based on a directional channel. a second movable arm, a second swellable material, a third movable arm, wherein the third movable arm is configured such that at least a portion of the third movable arm is extendable beyond or further from the body of the oral drug dosage form through a force provided by the second swellable material, and the third movable arm is configured to rotate on a first axis; a third movable arm, a third swellable material, and a fourth movable arm, wherein at least a portion of the fourth movable arm is extendable beyond or further from the body of the oral drug dosage form through a force provided by the third swellable material. a fourth movable arm configured to rotate on a second axis, the body including a first swellable material section configured to contain at least a portion of a first swellable material, and a first directional channel and a second directional channel operably connected to the first swellable material section, the first movable arm including a first contact element configured to interact with the first swellable material in proximity to the first directional channel, and the second movable arm including a second contact element configured to interact with the first swellable material in proximity to the second directional channel. the first swellable material section and the first contact element of the first movable arm and the second contact element of the second movable arm substantially surround the first swellable material, the first movable arm or a portion thereof is configured to slide within the first directional channel such that the first movable arm extends beyond or further away from the body of the oral drug dosage form along the axis, and the second movable arm or a portion thereof is configured to slide within the first directional channel such that the second movable arm extends beyond or further away from the body of the oral drug dosage form along the axis.a first directional channel and a second directional channel configured to slide within the second directional channel; one or more fluid inlets operably connected to the first swellable material section; a first stop configured to engage with the first movable arm in an extended position; a second stop configured to engage with the second movable arm in an extended position; a second swellable material section configured to contain at least a portion of a second swellable material; and a third directional channel operably connected to the second swellable material section, the third directional channel extending from the curved channel. a third directional channel and a third movable arm operably connected to the third swellable material section, wherein the third movable arm includes a contact element configured to interact with the second swellable material proximate the third directional channel, the second swellable material section and the contact element of the third movable arm substantially encircling the second swellable material, and the third movable arm, or a portion thereof, is configured to rotate on a first axis in a manner such that the contact element slides within the third directional channel such that the third movable arm extends beyond or further away from the body of the oral drug dosage form; a third swellable material section configured to contain at least a portion of a third swellable material; a fourth directional channel operatively connected to the third swellable material section, the fourth directional channel comprising a curved channel; a fourth movable arm comprising a contact element configured to interact with the third swellable material proximate to the fourth directional channel, the third swellable material section and the contact element of the fourth movable arm substantially surrounding the third swellable material; and the fourth movable arm, or a portion thereof, is configured to be in contact with the third swellable material of the oral drug dosage form. a fourth movable arm including a fourth directional channel configured to rotate on a second axis in a manner such that the contact element slides within the fourth directional channel to extend beyond or further away from the body; and one or more fluid inlets operatively connected to the third swellable material section; and a drug, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention, the elongated dosage form of the post-administration state of the oral drug dosage form being configured to expand in the presence of gastrointestinal fluids by the first swellable material, the second swellable material,and at least partially due to the expansion of the third swellable material.

[0140] In some embodiments, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising: a swellable material; first and second movable arms configured such that at least a portion of each movable arm is extendable beyond or away from a body of the oral drug dosage form via force provided by the swellable material; the first and second movable arms configured to rotate in opposite directions on a shared axis; the body comprising a swellable material section configured to contain at least a portion of the swellable material; and first and second directional channels operatively connected to the swellable material sections, the first and second directional channels being curved and configured about the shared axis; the first movable arm comprising a first contact element configured to interact with the swellable material proximate the first directional channel; the first contact element being ladder-shaped; and the first movable arm extending beyond the body of the oral drug dosage form relative to the shared axis. the first and second directional channels, the second movable arm including a second contact element configured to interact with the swellable material proximate the second directional channel, the second contact element being ladder-shaped, the second movable arm configured to move within the second directional channel to rotate over or further away from the body of the oral drug dosage form relative to a shared axis; one or more fluid inlets operably connected to the swellable material section; a first movable arm and a second movable arm including a stop or one or more stops configured to engage the first movable arm and the second movable arm in an extended position; and a drug; wherein the oral drug dosage form is configured to have a pre-dosage state having a compact dosage form and a post-dosage state having an extended dosage form that provides gastric retention, the extended dosage form of the oral drug dosage form in the post-dosage state being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid. In some embodiments, the stop or one or more stops are configured to engage the first contact element of the first movable arm and the second contact element of the second movable arm in the extended position.

[0141] In some embodiments, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising: a swellable material; a first movable arm, a second movable arm, a third movable arm, and a fourth movable arm, wherein the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the swellable material; a body, a swellable material compartment configured to contain at least a portion of the swellable material; and a directional channel and / or orifice operably connected to the swellable material compartment, wherein each movable arm is proximate to the directional channel and / or orifice to provide a force to the swellable material. the swellable material section, the contact elements of the movable arms, and the cap substantially enclose the swellable material; a directional channel and / or orifice; one or more fluid inlets operably connected to the swellable material section; a cap; a body including a first stop, a second stop, a third stop, and a fourth stop configured to engage with the first, second, third, and fourth movable arms, respectively, in an extended position; and a drug; wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an extended dosage form that provides gastric retention, the extended dosage form of the oral drug dosage form in the post-administration state being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid. In some embodiments, the oral drug dosage form further comprises a fifth movable arm. In some embodiments, the oral drug dosage form further comprises a sixth movable arm. In some embodiments, the oral drug dosage form further comprises an erodible restraint configured to prevent extension of the movable arm. In some embodiments, the swellable material is comprised of an associated non-swellable material that covers at least a portion of the swellable material, and in such embodiments, the associated non-swellable material can contact the movable arm.

[0142] In some embodiments, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising: a swellable material; a first movable arm, a second movable arm, a third movable arm, and a fourth movable arm, wherein the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the swellable material; a body, the body configured to contain at least a portion of the swellable material; and a directional channel and / or orifice operably connected to the swellable material section, wherein each movable arm is proximate to the directional channel and / or orifice. The oral drug dosage form includes a body including a directional channel and / or orifice including a contact element configured to interact with the swellable material, wherein the contact elements of the swellable material section and the movable arms substantially surround the swellable material; one or more fluid inlets operably connected to the swellable material section; and a first stop, a second stop, a third stop, and a fourth stop configured to engage with the first, second, third, and fourth movable arms, respectively, in an extended position; and a drug. The oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an extended dosage form that provides gastric retention, the extended dosage form of the oral drug dosage form in the post-administration state being due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid. In some embodiments, the oral drug dosage form further includes a fifth movable arm. In some embodiments, the oral drug dosage form further includes a sixth movable arm. In some embodiments, the oral drug dosage form further comprises an erodible restraint configured to prevent extension of the movable arm. In some embodiments, the swellable material is comprised of an associated non-swellable material that covers at least a portion of the swellable material, and in such embodiments, the associated non-swellable material can contact the movable arm.

[0143] In some embodiments, an oral drug dosage form configured for gastric retention is provided, the oral drug dosage form comprising: a swellable material at least partially encased in a semipermeable membrane; a first movable arm, a second movable arm, a third movable arm, and a fourth movable arm, wherein the first movable arm, the second movable arm, the third movable arm, and the fourth movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the swellable material; and a body having a first connection point for the first arm, a second connection point for the second arm, a third connection point for the third arm, and a fourth connection point for the fourth arm, wherein each connection point is connected to the first arm, the second arm, the third arm, and the fourth arm. and a body including a first connection point, a second connection point, a third connection point, and a fourth connection point configured to provide independent axes of rotation for the first, second, third, and fourth movable arms, each of which includes a contact element configured to interact with a swellable or semi-permeable material, and a first stop, a second stop, a third stop, and a fourth stop configured to engage the first, second, third, and fourth movable arms, respectively, in an extended position, wherein the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention, wherein the elongated dosage form of the oral drug dosage form in the post-administration state is due at least in part to expansion of the swellable material in the presence of gastrointestinal fluid. In some embodiments, the oral drug dosage form further includes a fifth movable arm. In some embodiments, the oral drug dosage form further comprises a sixth movable arm. In some embodiments, the oral drug dosage form further comprises an erodible restraint configured to prevent extension of the movable arm. In some embodiments, the swellable material is comprised of an associated non-swellable material that covers at least a portion of the swellable material, and in such embodiments, the associated non-swellable material can contact the movable arm. I. Drug Dosage Forms Configured for Other Cavities

[0144] The concept of the pharmaceutical dosage form or medical device of the present invention is not only applicable to oral administration, but may also be applied to other parts of the human body, such as the large intestine, small intestine, rectum, cecum, colon, vagina, and other parts, and the pharmaceutical dosage form or medical device described in the present invention is also applicable. Those skilled in the art will easily understand that these other cavities may have anatomical features that guide the taught features of the drug dosage form described herein. For example, the anatomical size of the rectum can guide the size of the drug dosage form before administration for such use, which may, in certain embodiments, be different from the size of the oral drug dosage form. That is, the retention mechanism taught herein for retention in an individual is still applicable. III. Commercial batch

[0145] In some aspects, provided herein is a commercial batch of oral drug dosage forms described herein. In some embodiments, the commercial batch comprises at least about 100, 150, 200, 250, 500, 750, 1,000, 2,500, 5,000, 7,500, 10,000, 20,000, 30,000, 40,000, 50,000, 60,000, 70,000, 80,000, 90,000, or 100,000 of the oral drug dosage forms described herein. In some embodiments, each of the oral drug dosage forms in the commercial batch is produced using the same technology, such as by three-dimensional (3D) printing, injection molding, ultrasonic welding, or any combination thereof, of one or more components of the oral drug dosage form.

[0146] In some embodiments, the commercial batches have a standard deviation of about 0.1 or less, e.g., 0.05 or less, for one or more of the amount of drug in the oral drug dosage form, the weight of the oral drug dosage form, the dimensions of the oral drug dosage form (e.g., pre-dosing state and / or post-dosing state), and the gastric retention time of the oral drug dosage form. In some embodiments, the dimensions of the oral drug dosage form are the maximum cross-sectional dimensions of the oral drug dosage form in the pre-dosing state. In some embodiments, the dimensions of the oral drug dosage form are the maximum cross-sectional dimensions of the oral drug dosage form after swelling of the swellable material (e.g., the post-dosing state in the stomach where the swellable material has swelled to a substantially complete state). In some embodiments, the dimensions of the oral drug dosage form are the transverse dimensions perpendicular to the maximum cross-sectional dimension of the oral drug dosage form after swelling of the swellable material (e.g., the post-dosing state in the stomach where the swellable material has swelled to a substantially complete state). IV. Generation method

[0147] In some aspects, provided herein are methods of producing the oral drug dosage forms described herein. In some embodiments, the production methods include three-dimensional (3D) printing techniques to form at least one of the components of the drug dosage forms described herein, or a portion thereof. In some embodiments, the production methods include the use of 3D printing, injection molding, ultrasonic welding, or any combination thereof. In some embodiments, the components of the oral drug dosage forms taught herein are manufactured separately and then assembled by machine and / or hand.

[0148] As used herein, "printing," "three-dimensional printing," "3D printing," "additive manufacturing," or their equivalents refer to the process of using digital designs to produce three-dimensional objects, such as delayed-release oral drug dosage forms, layer-by-layer. The basic process of three-dimensional printing is described in U.S. Patent Nos. 5,204,055, 5,260,009, 5,340,656, 5,387,380, 5,503,785, and 5,633,021. Additional U.S. patents and patent applications related to three-dimensional printing include U.S. Patent Nos. 5,490,962, 5,518,690, 5,869,170, 6,530,958, 6,280,771, 6,514,518, 6,471,992, 8,828,411, and U.S. Patent Application Publication Nos. 2002 / 0015728, 2002 / 0106412, 2003 / 0143268, 2003 / 0198677, and 2004 / 0005360. The contents of the above U.S. patents and patent applications are incorporated herein by reference in their entireties. In some embodiments, additive manufacturing techniques are used to produce the oral drug dosage forms or components thereof described herein. In some embodiments, layer-by-layer technology is used to produce the oral drug dosage forms or components thereof described herein. For example, in some embodiments, the layer-by-layer technology involves distributing one or more materials or components thereof across a first layer of the oral drug dosage form, and then proceeding to distribute one or more materials or components thereof across a second layer of the oral drug dosage form. In some embodiments, a layer, such as the first layer or second layer, is a cross-section of the oral drug dosage form or a component thereof. 3D printing is well suited to the production of drug dosage forms with complex geometries and compositions according to the present invention, as 3D printing can handle a range of pharmaceutical materials and may locally control both composition and structure.

[0149] In some embodiments, when used with respect to a component of a drug dosage form, e.g., a swellable material, the term "layer" refers to the configuration of a component of an oral drug dosage form and may include multiple printed layers of the same material. In some embodiments, the layer has a predetermined packing density, such as a three-dimensional printing packing density. In some embodiments, the layer includes a plurality of printed layers of between about 5 and about 2500 printed layers, e.g., between about 10 and about 2500 printed layers, between about 25 and about 100 printed layers, between about 50 and about 200 printed layers, between about 100 and about 200 printed layers, between about 150 and about 250 printed layers, between about 200 and about 250 printed layers, between about 500 and about 1000 printed layers, or between about 2000 and about 2400 printed layers. In some embodiments, the thickness of the printed layer is about 5 mm or less, for example, about any of 4 mm, 3 mm, 2 mm, 1 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, 0.1 mm, 0.09 mm, 0.08 mm, 0.07 mm, 0.06 mm, 0.05 mm, 0.04 mm, 0.03 mm, 0.02 mm, or 0.01 mm or less. In some embodiments, the thickness of the printed layer is about any of 5 mm, 4 mm, 3 mm, 2 mm, 1 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, 0.1 mm, 0.09 mm, 0.08 mm, 0.07 mm, 0.06 mm, 0.05 mm, 0.04 mm, 0.03 mm, 0.02 mm, or 0.01 mm.

[0150] Different 3D printing methods are developed for manufacturing in terms of raw materials, devices, and solidification. These 3D printing methods are based on binder deposition (Gibson et al.,Additive Manufacturing Technologies:3D Printing,Rapid Prototyping,and Direct Digital Manufacturing.,2 ed.Springer,New York,2015, Katstra et al.,Oral dosage forms fabricated by three dimensional printing,J Control Release,66,2000,Katstra et al.,Fabrication of complex oral delivery forms by three dimensional printing,Dissertation in Materials Science and Engineering,Massachusetts Institute of Technology,2001,Lipson et al.,Fabricated:The New World of 3D printing,John Wiley & Sons,Inc.,2013,Jonathan,Karim 3D printing in pharmaceutics:a new tool for designing customized drug delivery systems,Int J Pharm,499,2016),Material injection (Jonathan,Karim,3D printing in pharmaceutics:a new tool for designing customized drug delivery systems, Int J Pharm, 499, 2016), extrusion (see Gibson et al., Additive Manufacturing Technologies: 3D Printing, Rapid Prototyping, and Direct Digital Manufacturing. 2 ed. Springer, New York, 2015) and photopolymerization (see Melchels et al.,A review on stereolithography and its application in biomedical engineering. See Biomaterials, 31, 2010.

[0151] In some embodiments, the oral drug dosage forms described herein are 3D printed using an extrusion method. In some embodiments, the 3D printing method includes using a twin-screw extrusion method. In the extrusion process, material is extruded from a robotically controlled print head through a print nozzle. Unlike binder deposition, which requires a powder bed, extrusion methods can print on any substrate. A variety of materials can be extruded for three-dimensional printing, including the thermoplastic materials disclosed herein, pastes and colloidal suspensions, silicones, and other semi-solids. One extrusion printing method is fused extrusion deposition (MED), in which extruded material is used from a print head to print layers of material to form the oral drug dosage form or its components. Another common type of extrusion printing is fused deposition modeling, which uses a solid polymer filament for printing. In fused deposition modeling, a gear system drives the filament through a heated nozzle assembly for extrusion (see Gibson et al., Additive Manufacturing Technologies: 3D Printing, Rapid Prototyping, and Direct Digital Manufacturing, 2 ed. Springer, New York, 2015).

[0152] In some embodiments, 3D printing is performed by melt extrusion deposition (MED). In some embodiments, melt extrusion deposition techniques involve preparing the materials to be dispensed, such as preparing a powder in a hot melt extruder and then feeding the material to a MED print head. The MED print head then dispenses the materials to form the oral drug dosage form or its components in an additive (layer-by-layer) manner. In some embodiments, each material of the oral drug dosage form or its components is dispensed from a different MED print head. In some embodiments, the MED print head dispenses the materials according to instructions compiled into one or more gcode files. Exemplary MED techniques are disclosed, for example, in WO2019 / 137333, WO2018137686, and U.S. Patent No. 10,201,503, all of which are incorporated by reference herein in their entireties.

[0153] In some embodiments, the 3D printing is performed by fused deposition modeling (FDM). In some embodiments, the 3D printing is performed by molten extrusion deposition or hot melt extrusion combined with a 3D printing technique such as FDM. In some embodiments, the 3D printing is performed by non-filament FDM. In some embodiments, the 3D printing is performed by inkjet printing. In some embodiments, the 3D printing is performed by selective laser sintering (SLS). In some embodiments, the 3D printing is performed by stereolithography (SLA or SL). In some embodiments, 3D printing is performed by PolyJet, Multi-Jet Printing System (MJP), Perfactory, Solid Object Ultraviolet-Laser Printer, Biologetter, 3D Biorinting, Rapid Freeze Prototyping, Benchtop System, Selective Deposition Lamination (SDL), Laminated Object Manufacturing (LOM), Ultrasonic Consolidation, ColorJet Printing (CJP), EOSINT Systems, Laser Engineered Net Shaping (LENS) and Aerosol Jet System, Electron Beam Melting (EBM), Laser CUSING®, Selective Laser Melting (SLM), Phoenix PX™ Series, Microsintering, Digital Part Materialization (DPM), or VX System.

[0154] In some embodiments, the 3D printing methods described herein include continuous feed methods. In some embodiments, the 3D printing methods described herein include batch feed methods.

[0155] In some embodiments, the method for producing the drug dosage forms described herein includes a 3D printing technique, such as 3D printing combined with another technique, such as a combination of injection molding and 3D printing. In some embodiments, the production method further includes an injection molding technique. In some embodiments, the production method further includes an ultrasonic welding method. In some embodiments, the 3D printing technique, the injection molding technique, and the ultrasonic welding method can be used separately or in any combination.

[0156] Method instructions for 3D printing the drug dosage forms disclosed herein may be generated in a variety of ways, including direct coding, derivation from a solid CAD model, or other means inherent in the 3D printer's computer interface and application software. These instructions may include information regarding the number and spatial arrangement of droplets, as well as general 3D printing parameters such as droplet spacing in each linear dimension (X, Y, Z) and fluid volume or mass per droplet. For a given set of materials, these parameters may be adjusted to improve the quality of the resulting structure. The overall resolution of the resulting structure is a function of powder particle size, droplet size, printing parameters, and material properties.

[0157] In some embodiments, one or more components of the oral drug dosage form are fabricated separately, e.g., printed separately, and later assembled to form the oral drug dosage form. In some embodiments, all components of the oral drug dosage form are fabricated in a single process, e.g., printed in a single process, without the need for later assembly.

[0158] The oral drug dosage forms and components thereof described herein can be printed on a commercial scale. For example, in some embodiments, the methods disclosed herein may be used to 3D print 1,000 to 100,000 units of oral drug dosage forms per hour, including printing components for later assembly.

[0159] In some embodiments, each of the materials used to print the oral drug dosage form or its components is dispensed by a different print head. The 3D printing methods described herein encompass printing materials in any order that allows for the production of the oral drug dosage form or its components.

[0160] In some embodiments, the 3D printing method includes designing an oral drug dosage form or a component thereof, in whole or in part, on a computer system. In some embodiments, the method includes inputting desired gastric retention, drug release profile, and / or parameters of the oral drug dosage form and / or component(s) into a computer system. In some embodiments, the method includes providing one or more parameters to be printed, e.g., layer surface area, thickness, drug mass fraction, erosion rate. In some embodiments, the method includes providing a desired drug release profile. In some embodiments, the method includes creating a virtual image of the item to be printed. In some embodiments, the method includes creating a computer model containing predetermined parameters. In some embodiments, the method includes providing the predetermined parameters to a 3D printer and printing the item according to such predetermined parameters. In some embodiments, the method includes creating a 3D rendering of the item to be printed based on the predetermined parameters, the 3D rendering being created on a computer system. In some embodiments, the method includes converting the 3D rendering into 3D printing code, e.g., G-code, e.g., slicing. In some embodiments, the method includes using a computer system to execute 3D printing code, thereby printing according to the methods described herein. V. Methods of Delivering Drugs to Individuals

[0161] In some aspects, methods are provided for delivering an oral drug dosage form to an individual such that the oral drug dosage form remains in the individual's stomach for an extended period of time, the methods comprising orally administering any oral drug dosage form described herein to the individual. In some aspects, methods are provided for delivering a drug to the stomach and / or upper gastrointestinal tract of an individual, the methods comprising orally administering any oral drug dosage form described herein to the individual, the oral drug dosage form comprising a drug. In some embodiments, the drug is released from the oral drug dosage form into the stomach and / or upper gastrointestinal tract over an extended period of time (including a sustained-release profile, a delayed-release profile, a pulsatile-release profile, or any combination thereof). In some embodiments, the oral drug dosage form is configured to remain in the individual's stomach for an extended period of time (e.g., from at least about 8 hours to about 3 months). In some embodiments, the drug or drugs in the oral drug dosage form can be released from the oral drug dosage form at a predetermined time(s) after administration of the oral drug dosage form to the individual. For example, in some embodiments, the drug, or at least a portion thereof, is released in the individual's stomach when or after the oral drug dosage form reaches a post-administration state designed for gastric retention. In some embodiments, the drug, or at least a portion thereof, is released in the individual's stomach at least about any of 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 14 hours, 16 hours, 18 hours, 20 hours, 22 hours, 24 hours, 26 hours, 28 hours, 30 hours, 32 hours, 34 hours, or 36 hours after administering the drug dosage form to the individual.

[0162] Those skilled in the art will recognize that several embodiments are possible within the scope and spirit of the disclosure of this application. The present disclosure is further illustrated by the following examples, which should not be construed as limiting the disclosure to the scope or spirit of the specific procedures described herein. [Example]

[0163] Example 1 This example demonstrates the design and testing of an oral drug dosage form described herein configured for gastric retention.

[0164] Two illustrative models based on the design configurations shown in Figures 5A-5F were 3D printed with a material formulation of swellable material (LHB1:NaCl = 9:1). For both models, the body and movable arms were printed with a photopolymer. After printing, the two illustrative models were immersed in water so that the swellable material would swell and apply a force to the movable arms, causing them to rotate and extend beyond or further away from the body of the oral drug dosage form. At specific time points, the angle between the two movable arms was measured to assess the degree of dimensional expansion achieved by the drug dosage form upon swelling. The tested material formulations of the swellable components and their corresponding results are shown in Table 1 and Figure 16.

[0165] [Table 1] Example 2

[0166] This example demonstrates the design and testing of a drug dosage form described herein configured for gastric retention.

[0167] Two illustrative models based on the design configuration shown in Figures 7A-7I were 3D printed. The two illustrative models were printed with different designs of fluid inlets on the body, which allowed fluid to flow into the swellable material compartment. One model of the body had fluid inlets only on the side walls of the swellable compartment, while the other model of the body had fluid inlets on the top, bottom, and side walls of the swellable material compartment. The directional channels on the body portion were capped on both sides by two caps instead of movable arms. All fluid inlets were Φ1 mm. The third channel connecting the swellable compartment and the first directional channel in the body had a cross-section of 3.5 mm x 4 mm. The swellable material used in this test was PAANa (30-60 mesh). The remainder of the body and two cap embodiments were printed with a photopolymer.

[0168] After printing, the model was immersed in a pH 1.0 fluid such that the side of the first directional channel with the cap remained above the fluid, and the side(s) of the swellable compartment and the fluid inlet on the body were submerged. The extent to which the swellable material extended beyond the swellable material compartment and filled the first directional channel within a certain time was tested and recorded.

[0169] The fluid inlet designs for the two illustrative models are shown in Table 2.

[0170] [Table 2]

[0171] Both Model 1 and Model 2 had swellable material that completely filled the first directional channel within 2 minutes (FIG. 17). Example 3

[0172] This example demonstrates the design and testing of an oral drug dosage form described herein configured for gastric retention.

[0173] Ten replicate illustrative models based on the design configuration shown in Figures 8A-8I were 3D printed. The preparation methods, specific functions, and materials of the components of the oral drug dosage form are summarized in Table 3.

[0174] [Table 3]

[0175] For each illustrative model, the bottom frame and cap were printed with a photopolymer. The swellable material section was printed with EC:ATBC:BaSO4 = 65:15:20. The erodible restraint was printed with VA64:TEC = 9:1. The swellable material was a superabsorbent polymer (30-60 mesh). The movable arms were printed with EC:ATBC:BaSO4 = 60:20:20. Five of the illustrative models were placed in water with the bottom frame facing down and the arms facing up (upward stretching configuration), while the other five were placed in water with the bottom frame facing up and the arms facing down (downward stretching configuration). The extent to which the arms stretch upon swelling under different conditions is shown in Figure 18. As shown in Figure 18, an exemplary model of an oral drug dosage form was able to form a 30mm x 30mm post-dosing state within 30 minutes. Example 4

[0176] This example demonstrates the design and testing of an oral drug dosage form described herein configured for gastric retention.

[0177] Replicate illustrative models based on the design configurations shown in Figures 9A-9I were fabricated. The preparation methods, specific features, and materials of the components of the oral drug dosage form are summarized in Table 4.

[0178] [Table 4]

[0179] For each illustrative model, the bottom frame, cap, and movable arms were printed with a photopolymer. The swellable material section was printed with EC:ATBC:BaSO4 = 65:15:20. The erodible restraint was printed with VA64:TEC = 9:1. The swellable component was printed with a superabsorbent polymer (30-60 mesh). These 10 illustrative models were immersed in water, and the arms were measured over time. The extent to which the arms widened upon swelling is shown in Table 5.

[0180] [Table 5]

[0181] The dimensional expansion of oral drug dosage forms upon swelling was also examined in vivo. To enable in vivo imaging, the formulation of the swellable material compartment contained BaSO4. Additionally, a strip with an imaging agent was attached to the surface of the movable arm to visualize the arm position.

[0182] One male beagle dog was used in this study. Prior to administration of the oral drug dosage form, the dog was fasted for 14 hours, with water available. Dog food was offered 4 hours after administration of the oral drug dosage form, and water was provided throughout the experiment. The drug dosage form was swallowed whole with 20 mL of water without being broken, chewed, or crushed. To evaluate the retention time and condition of the oral drug dosage form, X-ray images of the drug dosage form were collected before and 10 minutes, 30 minutes, 1 hour, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 14 hours, 24 hours, and 26 hours after administration. Both frontal and side-view images were taken at each time point. The collected X-ray images, the position of the drug dosage form, and the extent to which the movable arm extended outward at each collection time point are shown in Figures 19A and 19B. As shown in Figures 19A and 19B, the oral drug dosage form was retained in the stomach for an extended period of time with the movable arm in the extended position, and the oral drug dosage form was able to remain in the stomach for at least about 14 hours. Example 5

[0183] This example demonstrates the design and testing of an oral drug dosage form described herein configured for gastric retention.

[0184] An illustrative model based on the design configuration shown in Figures 14A-14B was constructed.

[0185] For the illustrative model, the base frame, cap, and movable arms were injection molded with PLA and ABS. The swellable components were tableted with PEO 700W:CCNa:BaSO4 = 56:24:20. The erodible restraints were printed with VA64:TEC = 85:15.

[0186] The dimensional expansion of oral drug dosage forms during swelling was studied in vivo. To enable in vivo imaging, the formulation of the swellable material compartment contained BaSO4. Additionally, a strip with an imaging agent was attached to the surface of the movable arm to visualize the arm position.

[0187] One male beagle dog was used in this study. Prior to administration of the oral drug dosage form, the dog was fasted for 14 hours, with water available. Dog food was offered 4 hours after administration of the oral drug dosage form, and water was provided throughout the experiment. The drug dosage form was swallowed whole with 20 mL of water without being broken, chewed, or crushed. To assess the retention time and condition of the oral drug dosage form, X-ray images of the drug dosage form were collected before and 30 minutes after administration, and at 1.5 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 23 h, 24 h, 30 h, 36 h, 48 h, and 52 h. Both frontal and side-view images were taken at each time point. The collected X-ray images, the position of the drug dosage form, and the extent to which the movable arm extended outward at each collection time point are shown in Figures 20A and 20B. As shown in Figures 20A and 20B, the oral drug dosage form was retained in the stomach for an extended period of time with the movable arm in the extended position, and the oral drug dosage form was able to remain in the stomach for at least about 36 hours. Example 6

[0188] As shown in Figure 22A, the drug dosage form model was fixed in a fixture, and then the bottom was immersed in 5 mL of purified water medium to observe the deployment of the unfolding arms. As shown in Figure 23B, it was found that the unfolding arms were unfolded 120° in 5 minutes. The above experiment indicates that in vivo drug dosage form retention can be developed with less fluid, and has potential applications for colonic retention or vaginal retention. Example 7

[0189] This example demonstrates the design and testing of an oral drug dosage form described herein configured for gastric retention.

[0190] An illustrative model based on the design configuration shown in Figures 22A-22B was constructed.

[0191] For the illustrative model, the bottom frame, cap and movable arm were made of HPMC and the swellable component was tableted with PEO.

[0192] This study was conducted to evaluate the in vivo safety after oral administration of a placebo candidate formulation once daily for seven consecutive days by gastroscopy, fecal occult blood (OB) testing, and residue collected from the feces.

[0193] The placebo candidate formulation was orally administered once daily for 7 consecutive days to three beagle dogs under fed conditions. Gastroscopy was performed on Day 0 (pre-dose) and Day 8 (after the last dose), and OB testing was performed daily to assess in vivo safety when the placebo candidate formulation was orally administered to the beagle dogs.

[0194] Gastroscopy of three beagle dogs orally administered the placebo candidate for seven consecutive days showed that no changes were observed on day 8 compared to day 0, demonstrating that no directly observable damage occurred between doses. Gastroscopy (days 0 and 8) is shown in Figure 24.

[0195] Fecal occult blood test results collected over seven consecutive days of dosing were all negative, indicating that the placebo candidate formulation did not cause any damage to the GI tract of the beagle dogs during the GI transition. The fecal occult blood test results are shown in Figure 25.

[0196] The remainder of the placebo candidate formulation was collected and all remainder was soft. A picture of the remainder collected from the feces of the beagle dogs is shown in Figure 26.

[0197] Beagle dogs ate and behaved normally after seven consecutive days of oral administration of the placebo candidate formulation. No damage to the GI tract of the beagle dogs was observed between doses.

Claims

1. 1. An oral drug dosage form configured for gastric retention, comprising: a swellable material; wherein at least a portion of the movable arm is extendable beyond or configured to rotate about a body of the oral pharmaceutical dosage form via a force provided by the swellable material; The body includes: a swellable material section configured to contain at least a portion of the swellable material, the swellable material section operatively including one or more fluid inlets; a directional channel and orifice operatively connected to the swellable material section, the movable arm including a directional channel and an orifice, the movable arm including a contact element in proximity to the directional channel and the orifice configured to interact with the swellable material or a feature associated with the swellable material; a drug; the oral drug dosage form is configured to have a pre-dosage state having a compact dosage form and a post-dosage state having an elongated dosage form that provides gastric retention; The oral drug dosage form, wherein the elongated dosage form of the post-administration state of the oral drug dosage form is due at least in part to expansion of the swellable material in the presence of gastrointestinal fluids.

2. 10. The oral drug dosage form of claim 1, wherein the feature associated with the swellable material comprises a plunger or piston.

3. 10. The oral drug dosage form of claim 1, wherein the movable arm or body includes a pivot, the movable arm being connected to the body by a pivot.

4. 10. The oral drug dosage form of claim 1, wherein the swellable material section comprises a cap and a base, and the pivot of the movable arm is connected to the cap.

5. 5. The oral drug dosage form of any one of claims 1 to 4, wherein the post-administration state of the oral drug dosage form occurs within 2 hours after administration of the oral drug dosage form to the individual.

6. 5. The oral drug dosage form of any one of claims 1 to 4, wherein the gastric retention of the oral drug dosage form is from about 6 hours to about 3 months.

7. 5. The oral drug dosage form of claim 1, wherein the swellable material expands in volume by at least about 1.2 times after exposure to gastrointestinal fluids.

8. 6. The oral pharmaceutical dosage form of claim 1, wherein the swellable material has a volume expansion rate of at least about 1.2 times in 30 minutes.

9. 6. An oral drug dosage form according to any one of claims 1 to 5, wherein the swellable material, upon swelling, at least partially conforms to the shape of the directional channel and the orifice, or a portion thereof.

10. An oral pharmaceutical dosage form according to any one of claims 1 to 5, wherein the swellable material assumes a predetermined shape and / or size upon swelling.

11. 6. The oral pharmaceutical dosage form of claim 1, wherein the swellable material in the swellable material compartment is in an amount of at least about 5 mg.

12. 6. The oral pharmaceutical dosage form of any one of claims 1 to 5, wherein the swellable material comprises sodium alginate (SA), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), hydroxypropyl methylcellulose (HPMC), polyethylene oxide (PEO), polyvinyl alcohol (PVA), microcrystalline cellulose (MCC), croscarmellose sodium (CCNa), carboxymethyl cellulose sodium (CMC-Na), polyvinylpolypyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), polyethylene glycol (PEG), or a mixture thereof.

13. 6. The oral pharmaceutical dosage form of claim 1, wherein the swellable material comprises a gas generating substance.

14. 14. The oral drug dosage form of claim 13, wherein the swellable material further comprises a salt or mixture of salts, the salt being selected from the group consisting of sodium salts, magnesium salts, and potassium salts.

15. The swellable material has a thickness of about 10 mm ３ ~ approx. 50 mm ３ 6. The pharmaceutical dosage form according to claim 1, having a swelling volume of

16. 3. The drug dosage form of claim 2, wherein the plunger or piston rotates about the body to push the arms into an expanded dosage form.

17. 6. The oral drug dosage form of claim 1, wherein the body comprises two or more parts configured to form the body.

18. 6. The oral pharmaceutical dosage form of claim 1, wherein the body comprises two or more materials.

19. The oral drug dosage form of any one of claims 1 to 5, wherein the body of the oral drug dosage form is a monolithic structure.

20. 6. An oral pharmaceutical dosage form according to any one of claims 1 to 5, wherein the maximum transverse dimension of said oral pharmaceutical dosage form in a pre-dosed state is 24 mm or less.

21. 6. An oral pharmaceutical dosage form according to any one of claims 1 to 5, wherein at least two vertical dimensions of said oral pharmaceutical dosage form in the administered state are 20 mm or greater.

22. 6. The oral pharmaceutical dosage form of claim 1, wherein the swellable material section is configured to substantially contain the swellable material in a pre-administration state.

23. 6. An oral drug dosage form according to any one of claims 1 to 5, wherein the swellable material section and the contact element of the movable arm substantially surround the swellable material.

24. 6. An oral drug dosage form according to any one of claims 1 to 5, wherein the directional channel is configured to direct movement of the movable arm through the swellable material.

25. The oral pharmaceutical dosage form of any one of claims 1 to 5, wherein the directional channels include curved channels, straight channels, circular channels, oval channels, capsule-shaped channels, square or rectangular channels.

26. The pharmaceutical dosage form according to any one of claims 1 to 4, wherein the pharmaceutical dosage form can be taken orally or can be located in the stomach, small intestine, large intestine, rectum, colon, or vagina.

27. 5. The oral drug dosage form of claim 4, wherein the body or base is a semipermeable membrane.

28. 28. The oral pharmaceutical dosage form of claim 27, wherein the at least one of the one or more fluid inlets is the semi-permeable material filling a pore formed by the body.

29. 6. An oral pharmaceutical dosage form according to any one of claims 1 to 5, wherein at least one of the one or more fluid inlets is a pore.

30. 6. An oral pharmaceutical dosage form according to any one of claims 1 to 5, wherein the body further defines a stop configured to engage the movable arm in an extended position.

31. 31. The oral drug dosage form of claim 30, wherein the stop includes a locking element configured to maintain the movable arm in one or more extended positions.

32. 6. The oral pharmaceutical dosage form of claim 1, wherein the body has a wall thickness of at least about 0.4 mm.

33. 6. An oral pharmaceutical dosage form according to any one of claims 1 to 5, wherein at least two of the movable arms have different movement mechanisms or the same movement mechanism.

34. 6. The oral drug dosage form of claim 1, further comprising a second swellable material at least partially contained in a second swellable material section formed by the body, and wherein at least one of the movable arms is configured such that at least a portion of the movable arm is extendable beyond or further away from the body of the oral drug dosage form or rotates about the body via a force provided by the second swellable material.

35. 6. The oral pharmaceutical dosage form of claim 1, wherein the arms have a thickness of at least about 1 mm.

36. 6. The oral pharmaceutical dosage form of claim 1, further comprising an erodible restraint configured to prevent extension of the movable arm.

37. 37. The oral drug dosage form of claim 36, wherein the erodible restraint erodes within about 30 minutes after administration to an individual.

38. An oral drug dosage form according to any one of claims 1 to 5, wherein the drug is located within one or more of the movable arms and / or the body.

39. 39. The oral drug dosage form of claim 38, wherein the drug is selected from the group consisting of ribonuclease, aceclofenac, bicalutamide, carbamazepine, carvedilol, clotrimazole, cinnarizine, danazol, dapsone, estradiol, ethiofen glibenclamide, fenofibrate, griseofulvin, ibuprofen, itraconazole, ketoconazole, mefenamic acid, naproxen, nevirapine, nifedipine, nitrofurantoin, nomegestrol acetate, phenytoin sodium salt, piroxicam, praziquantel, rifampicin, sulfamethoxazole, trimethoprim, and verapamil hydrochloride.

40. 1. An oral drug dosage form configured for gastric retention, comprising: a swellable material; a movable arm configured such that at least a portion of the movable arm is extendable beyond or further away from a body of the oral pharmaceutical dosage form via a force provided by the swellable material, The body includes: a swellable material section configured to contain at least a portion of the swellable material; a directional channel operatively connected to the swellable material section, the movable arm includes a contact element configured to interact with the swellable material proximate the directional channel; the swellable material section and the contact element of the movable arm substantially surround the swellable material; a directional channel, wherein the movable arm, or a portion thereof, is configured to slide within the directional channel such that the movable arm extends beyond or further away from the body of the oral drug dosage form along an axis based on the directional channel; one or more fluid inlets operably connected to the swellable material section; a stop configured to engage the movable arm in an extended position; a drug; the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention; The oral drug dosage form, wherein the elongated dosage form of the post-administration state of the oral drug dosage form is due at least in part to expansion of the swellable material in the presence of gastrointestinal fluids.

41. 41. The oral drug dosage form of claim 40, wherein the stop includes a locking element configured to maintain the movable arm in one or more extended positions.

42. 42. The oral drug dosage form of claim 41, wherein the locking element is configured to maintain the movable arm in a single position.

43. 43. The oral drug dosage form of claim 42, wherein the locking element is configured to maintain the movable arm in a plurality of advanced positions.

44. 1. An oral drug dosage form configured for gastric retention, comprising: a swellable material; a first movable arm and a second movable arm, the first movable arm and the second movable arm are configured such that at least a portion of each movable arm is extendable beyond or away from a body of the oral pharmaceutical dosage form via a force provided by the swellable material; the first movable arm and the second movable arm extend in substantially opposite directions along an axis based on the directional channel; The body includes: a swellable material section configured to contain at least a portion of the swellable material; a first directional channel and a second directional channel operably connected to the swellable material section, the first movable arm including a first contact element configured to interact with the swellable material proximate the first directional channel; the second movable arm includes a second contact element configured to interact with the swellable material proximate the second directional channel; the swellable material section and the first contact element of the first movable arm and the second contact element of the second movable arm substantially surround the swellable material; the first movable arm, or a portion thereof, is configured to slide within the first directional channel such that the first movable arm extends beyond or further away from the body of the oral drug dosage form along the axis; the first directional channel and a second directional channel, wherein the second movable arm, or a portion thereof, is configured to slide within the second directional channel such that the second movable arm extends beyond or further away from the body of the oral drug dosage form along the axis; one or more fluid inlets operably connected to the swellable material section; a first stop configured to engage the first movable arm in the extended position; a second stop configured to engage the second movable arm in an extended position; and a drug; the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention; The oral drug dosage form, wherein the elongated dosage form of the post-administration state of the oral drug dosage form is due at least in part to expansion of the swellable material in the presence of gastrointestinal fluids.

45. 1. An oral drug dosage form configured for gastric retention, comprising: a first swellable material; and a first movable arm, the first movable arm is configured such that at least a portion of the movable arm is extendable beyond or further away from a body of the oral pharmaceutical dosage form via a force provided by the first swellable material; a first movable arm configured to rotate on a first axis; a second swellable material; and a second movable arm, the second movable arm is configured such that at least a portion of the movable arm is extendable beyond or further away from the body of the oral pharmaceutical dosage form via a force provided by the second swellable material; the second movable arm is configured to rotate on a second axis; The body includes: a first swellable material section configured to contain at least a portion of the first swellable material; a first directional channel operably connected to the first section of swellable material, the first directional channel comprises a curved channel; the first movable arm including a first contact element configured to interact with the first swellable material proximate the first directional channel; the first swellable material section and the first contact element of the first movable arm substantially surround the first swellable material; a first directional channel, wherein the first movable arm, or a portion thereof, is configured to rotate on the first axis in a manner such that the first contact element slides within the first directional channel such that the first movable arm extends beyond or further away from the body of the oral drug dosage form; one or more fluid inlets operably connected to the first section of swellable material; a second swellable material section configured to contain at least a portion of the second swellable material; a second directional channel operatively connected to the second section of swellable material, the second directional channel comprises a curved channel; the second movable arm includes a second contact element configured to interact with the second swellable material proximate the second directional channel; the second swellable material section and the second contact element of the second movable arm substantially surround the second swellable material; a second directional channel, wherein the second movable arm, or a portion thereof, is configured to rotate on the second axis in a manner such that the second contact element slides within the second directional channel such that the second movable arm extends beyond or further away from the body of the oral drug dosage form; one or more fluid inlets operably connected to the second section of swellable material; and a drug; the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention; The oral drug dosage form, wherein the elongated dosage form of the post-administration state of the oral drug dosage form is due at least in part to expansion of the swellable material in the presence of gastrointestinal fluids.

46. 1. An oral drug dosage form configured for gastric retention, comprising: a first swellable material; and a first movable arm and a second movable arm, the first movable arm and the second movable arm are configured such that at least a portion of each movable arm is extendable beyond or away from a body of the oral pharmaceutical dosage form via a force provided by the first swellable material; the first movable arm and the second movable arm extending in substantially opposite directions along an axis based on the directional channel; a second swellable material; and a third movable arm, the third movable arm is configured such that at least a portion of the third movable arm is extendable beyond or further away from the body of the oral pharmaceutical dosage form via a force provided by the second swellable material; a third movable arm configured to rotate on a first axis; a third swellable material; and a fourth movable arm, the fourth movable arm is configured such that at least a portion of the fourth movable arm is extendable beyond or further away from the body of the oral pharmaceutical dosage form via a force provided by the third swellable material; the fourth movable arm is configured to rotate on a second axis; The body includes: a first swellable material section configured to contain at least a portion of the first swellable material; a first directional channel and a second directional channel operably connected to the first section of swellable material, the first movable arm including a first contact element configured to interact with the first swellable material proximate the first directional channel; the second movable arm includes a second contact element configured to interact with the first swellable material proximate the second directional channel; the first swellable material section and the first contact element of the first movable arm and the second contact element of the second movable arm substantially surround the first swellable material; the first movable arm, or a portion thereof, is configured to slide within the first directional channel such that the first movable arm extends beyond or further away from the body of the oral drug dosage form along the axis; the first directional channel and a second directional channel, wherein the second movable arm, or a portion thereof, is configured to slide within the second directional channel such that the second movable arm extends beyond or further away from the body of the oral drug dosage form along the axis; one or more fluid inlets operably connected to the first section of swellable material; a first stop configured to engage the first movable arm in the extended position; a second stop configured to engage the second movable arm in the extended position; a second swellable material section configured to contain at least a portion of the second swellable material; a third directional channel operatively connected to the second section of swellable material, the third directional channel comprises a curved channel; the third movable arm includes a contact element configured to interact with the second swellable material proximate the third directional channel; the second swellable material section and the contact element of the third movable arm substantially surround the second swellable material; a third directional channel, wherein the third movable arm, or a portion thereof, is configured to rotate on the first axis in a manner such that the contact element slides within the third directional channel such that the third movable arm extends beyond or further away from the body of the oral drug dosage form; one or more fluid inlets operably connected to the third section of swellable material; a third swellable material section configured to contain at least a portion of the third swellable material; a fourth directional channel operatively connected to the third section of swellable material, the fourth directional channel comprises a curved channel; the fourth movable arm including a contact element configured to interact with the third swellable material proximate the fourth directional channel; the third swellable material section and the contact element of the fourth movable arm substantially surround the third swellable material; a fourth directional channel, wherein the fourth movable arm, or a portion thereof, is configured to rotate on the second axis in a manner such that the contact element slides within the fourth directional channel such that the fourth movable arm extends beyond or further away from the body of the oral drug dosage form; the fourth movable arm including one or more fluid inlets operatively connected to the third section of swellable material; a drug; the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention; The oral drug dosage form, wherein the elongated dosage form in the post-administration state is due at least in part to the expansion of the first swellable material, the second swellable material, and the third swellable material in the presence of gastrointestinal fluids.

47. 1. An oral drug dosage form configured for gastric retention, comprising: a swellable material; a first movable arm and a second movable arm, the first movable arm and the second movable arm are configured such that at least a portion of each movable arm is extendable beyond or away from a body of the oral pharmaceutical dosage form via a force provided by the swellable material; the first movable arm and the second movable arm are configured to rotate in opposite directions on a shared axis; The body includes: a swellable material section configured to contain at least a portion of the swellable material; a first directional channel and a second directional channel operably connected to the swellable material section, the first directional channel and the second directional channel are curved and configured about the shared axis; the first movable arm including a first contact element configured to interact with the swellable material proximate the first directional channel; the first contact element is ladder-shaped and configured to move within the first directional channel such that the first movable arm rotates beyond or further away from the body of the oral drug dosage form relative to the shared axis; the second movable arm includes a second contact element configured to interact with the swellable material proximate the second directional channel; the first and second directional channels, wherein the second contact element is ladder-shaped and configured to move within the second directional channel such that the second movable arm rotates beyond or further away from the body of the oral drug dosage form relative to the shared axis; one or more fluid inlets operably connected to the swellable material section; a stop configured to engage the first and second movable arms in an extended position; a drug; the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention; The oral drug dosage form, wherein the elongated dosage form of the post-administration state of the oral drug dosage form is due at least in part to expansion of the swellable material in the presence of gastrointestinal fluids.

48. 1. An oral drug dosage form configured for gastric retention, comprising: A swellable material, the swellable material at least partially enclosed in a semipermeable membrane; a first movable arm, a second movable arm, the first movable arm and the second movable arm are configured to rotate on independent axes in a direction toward a vertical plane via a force provided by the swellable material; The main body is a first connection point for the first arm, a second connection point for the second arm, each connection point is configured to provide an independent axis for rotation of the first arm and the second arm; the connection point, wherein each movable arm includes a contact element configured to interact with the swellable material or the semi-permeable material; a first stop and a second stop configured to engage the first movable arm and the second movable arm, respectively, in an extended position; the oral drug dosage form is configured to have a pre-administration state having a compact dosage form and a post-administration state having an elongated dosage form that provides gastric retention; and a body including the first stopper, a second stopper, and wherein the elongated dosage form in the post-administration state of the oral drug dosage form is due at least in part to expansion of the swellable material in the presence of gastrointestinal fluids.

49. 49. The oral pharmaceutical dosage form of claim 48, wherein the swellable material is positioned on the body such that expansion of the swellable material actuates the first movable arm, the second movable arm to an extended position.

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