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WO2025046044A1 - Nouveaux procédés de préparation de compositions semi-solides et leurs utilisations - Google Patents

Nouveaux procédés de préparation de compositions semi-solides et leurs utilisations Download PDF

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Publication number
WO2025046044A1
WO2025046044A1 PCT/EP2024/074239 EP2024074239W WO2025046044A1 WO 2025046044 A1 WO2025046044 A1 WO 2025046044A1 EP 2024074239 W EP2024074239 W EP 2024074239W WO 2025046044 A1 WO2025046044 A1 WO 2025046044A1
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WO
WIPO (PCT)
Prior art keywords
use according
gel
polyethylene oxide
dry solid
solid composition
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Application number
PCT/EP2024/074239
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English (en)
Inventor
Peter Kühl
Si Ying LAI
Leonie Flurina Claude Wagner-Hattler
Original Assignee
F. Hoffmann-La Roche Ag
Hoffmann-La Roche Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by F. Hoffmann-La Roche Ag, Hoffmann-La Roche Inc. filed Critical F. Hoffmann-La Roche Ag
Publication of WO2025046044A1 publication Critical patent/WO2025046044A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Definitions

  • the present invention generally relates to the preparation of semi-solid, gel-forming compositions. More specifically, the present invention related to the field of semi-solid pharmaceutical dosage forms for oral administration of drugs to patient populations with difficulties to swallow.
  • Solid formulation that are used for instant preparation of a semi-solid, jelly form for the administration of drug, particularly for those patients who may have difficulties in swallowing solid dosage forms, are known in the art.
  • W02005/107713 discloses swellable powder systems forming a gel within 5 minutes without application of mixing forces.
  • the formation of a gel is primarily related to the use of gellan gum that are further combined with swelling and gelling agents.
  • Powder blend can be filled into spoon, which sealed foil. This relates to the original Parvulet system invented by Bar-Shalom.
  • W02022/011341 Al discloses gel forming tablets or mini-tablets that primarily contain gellan gum as gel forming agent and an osmogen.
  • the regular tablets convert to the semi-solid form within 30- 90 seconds.
  • Fig- 1 Tablet holder with ring.
  • Fig- 2 Water uptake of tablet using tensiometer with ring holder for different binary combinations of gel formers; tablet weight dry: 350 mg.
  • Fig- 3 Viscosities in dependency of shear rate for various gelled tablet systems combining two gel formers and a wi eking agent, tablet weight: 350 mg
  • Fig- 4 Water uptake of tablets using tensiometer with ring holder containing kappa- carrageenan, polyethylene oxide and calcium silicate; tablet mass dry: 350 mg.
  • Fig- 5 Water uptake of tablets using tensiometer with ring holder containing kappa- carrageenan, sodium polyacrylate and calcium silicate, tablet mass dry: 350 mg.
  • Fig. 7 Water uptake of gelling tablet containing optionally a drug, formulation system with polyethylene oxide and kappa-carrageenan.
  • Fig. 8 Gelling behavior of a tablet over time described by images at the example of formulation with 2.5% polyethylene oxide, 2.5% kappa-carrageenan and 5% calcium silicate (F58-2).
  • Fig. 9 Gelling behavior of a tablet over time described by images at the example of formulation with 7.5% polyethylene oxide, 7.5% kappa-carrageenan and 10% calcium silicate (F58-10).
  • the present invention provides improved dry solid compositions for use in the preparation of semi-solid gel bodies.
  • Said gel bodies are formed upon addition of water to the present dry solid compositions and can, for example, be used as oral dosage form for the administration of drugs to patients with difficulties to swallow.
  • the present invention provides a solution to these problems by providing novel combinations of gel forming agents and wicking agents and their use in the preparation of dry solid compositions which lead to a rapid gel-formation upon the addition of water.
  • the present compositions and uses also lead to stable, homogenous gels with an improved drug load and a favorable drug-release profile.
  • the term “rapid” as used herein means within 180 seconds; or within 120 seconds; or within 60 seconds; or within 30 seconds. In one embodiment, rapid means within 30 seconds. In another embodiment, rapid means any time between 30 and 180 seconds.
  • the present invention provides the combined use of two gel forming agents and a wicking agent in the preparation of a dry solid composition as a precursor for a stable gel body formation upon addition of water to said dry solid composition.
  • 2mL of water was added to a dry solid 350 mg tablet on a spoon using a plastic pipette.
  • gel forming agent means an agent independently selected from kappa-carrageenan (Ph.Eur., USP-NF), polyethylene oxide (USP-NF), pectin (USP), sodium polyacrylate (polymerization degree: 2.700-7.500) and sodium alginate (Ph.Eur., USP-NF, 60-170 mPas for 1% solution).
  • the gel forming agent is polyethylene oxide with an average molecular weight (MW) of about 100.000 g/mol.
  • MW average molecular weight
  • the following combinations of gel forming agents and respective ratios are preferred:
  • the polyethylene oxide preferably has an average molecular weight (MW) of about 100.000 g/mol (max. 10.0% in total of the dry tablet mass).
  • ratios used throughout this specification are weight ratios (w/w).
  • wicking agent as used herein means an agent independently selected from highly porous calcium silicate (USP-NF) and highly porous magnesium aluminometasilicate (JP, USP- NF, Ph.Eur).
  • the wicking agent is highly porous calcium silicate at a concentration of about 5 to about 10% (w/w) in the dry solid composition.
  • the wicking agent is highly porous magnesium aluminometasilicate at a concentration of about 7 to about 8% (w/w), preferably at about 7.5% (w/w) in the dry solid composition.
  • the present invention provides any of the uses described hereinbefore for the preparation of a pharmaceutical composition, preferably a dry tablet, which comprises an active pharmaceutical ingredient and, optionally, additional pharmaceutically acceptable excipients.
  • active pharmaceutical ingredient means any therapeutically active agent or a drug, which is suitable for oral administration, preferably by administration via a tablet or a gel.
  • the API is a small molecule or an oligonucleotide.
  • small molecule and oligonucleotide are well known to a person of skill in the art, for example a medical practitioner or a medicinal Chemist.
  • a huge number of small molecule APIs is already approved or in development such as, for example, acetoaminophen or ibuprofen which are used herein as model compounds.
  • the term “small molecule” refers to molecules, whether naturally-occurring or artificially created (e.g., via chemical synthesis) that have a relatively low molecular weight.
  • a small molecule is an organic compound (i.e., it contains carbon).
  • the small molecule may contain multiple carbon-carbon bonds, stereocenters, and other functional groups (e.g., amines, hydroxyl, carbonyls, and heterocyclic rings, etc.).
  • the molecular weight of a small molecule is not more than about 1,000 g/mol, not more than about 900 g/mol, not more than about 800 g/mol, not more than about 700 g/mol, not more than about 600 g/mol, not more than about 500 g/mol, not more than about 400 g/mol, not more than about 300 g/mol, not more than about 200 g/mol, or not more than about 100 g/mol.
  • the molecular weight of a small molecule is at least about 100 g/mol, at least about 200 g/mol, at least about 300 g/mol, at least about 400 g/mol, at least about 500 g/mol, at least about 600 g/mol, at least about 700 g/mol, at least about 800 g/mol, or at least about 900 g/mol, or at least about 1,000 g/mol. Combinations of the above ranges (e.g., at least about 200 g/mol and not more than about 500 g/mol) are also possible.
  • the small molecule is a therapeutically active agent such as a drug (e.g., a molecule approved by the U.S.
  • the small molecule may also be complexed with one or more metal atoms and/or metal ions.
  • the small molecule is also referred to as a “small organometallic molecule.”
  • Preferred small molecules are biologically active in that they produce a biological effect in animals, preferably mammals, more preferably humans.
  • the small molecule is a drug.
  • the drug is one that has already been deemed safe and effective for use in humans or animals by the appropriate governmental agency or regulatory body. For example, drugs approved for human use are listed by the FDA under 21 C.F.R.
  • the API is a small molecule drug suitable for oral administration to a patient, preferably a patient with difficulties to swallow.
  • compositions are known to a person of ordinary skill in preparing/providing pharmaceutical dosage forms such as tablets.
  • pharmaceutically acceptable excipients are those typically used to prepare oral dosage forms.
  • pharmaceutically acceptable excipients may be mannitol or microcrystalline cellulose (see e.g. Table 2). Patients with difficulties to swallow may, for example be pediatric or geriatric patients or patients with certain types of diseases which do not allow them to swallow easily.
  • the API is present in the pharmaceutical compositions, obtained from the uses in accordance with the present invention, in an amount up to 30% (w/w) of the final drug product; or in an amount ranging from 25-30% (w/w) of the final drug product.
  • the present invention provides the uses as defined herein before for the preparation of a stable gel body upon the addition of water to said dry solid composition or tablet.
  • said stable gel body is formed within 30 seconds after the addition of water.
  • stable gel body as used herein means a gel body which shows sufficient gel firmness, no disintegration into fractional parts and no solid dry core after a maximum of 3 minutes subsequent to the addition of water.
  • FaSSIF has its ordinary meaning known to a person of skill in the art. In one embodiment, FaSSIF is as for example described in S. Klein, The Use of Biorelevant Dissolution Media to Forecast the In Vivo Performance of a Drug, AAPS Journal, Vol. 12, No. 3, September 2010 (# 2010) DOI: 10.1208/sl2248-010-9203-3.
  • SGF simulated gastric fluid
  • the present invention provides the uses as described herein before for the preparation of an oral dosage form for the administration of medicaments to patients with difficulties to swallow such as, for example, pediatric or geriatric patients or patients whose disease state does not allow them to swallow easily.
  • the present invention provides a dry solid composition, stable gel body or pharmaceutical composition obtained through any of the uses as defined herein before.
  • Table 1 summarizes parameters and criteria to describe targeted properties of compositions (dry solid compositions and gels) in accordance with the present invention.
  • Table 1 Features and related parameters describing properties of suitable gel forming tablets
  • Table 2 summarizes Materials (Ingredients) used to make compositions in accordance with the present invention.
  • the amounts of ingredients are weighed, subsequently mixed in a tumble bin mixer for a time equivalent to approximately 160 rotations.
  • the mixed blend is then sieved with a 1mm meshed sieve followed again by mixing in a tumble bin mixer at same time and speed.
  • the amount of lubricant is sieved and added to the blend and mixed.
  • the final dry blend is dry granulated using a roller compactor at a compaction force of approximately 3 kN/cm.
  • the granules are screen milled with approx. 1 mm meshed screen.
  • the amount of lubricant is sieved and added to the blend or granules and mixed for another time equivalent to approx. 50 to 160 rotations.
  • the final blends are compressed to tablets using a single punch or rotary press at targeted solid fraction that results in sufficient tablet hardness and acceptable friability, e.g. 0.75 to 0.80.
  • the tablet are flat-faced round shaped with a diameter of 11 mm and tablet weight 350 mg nominal, and 352 mg for lubricated final blends retrospectively.
  • the tablets can be placed on a teaspoon or medical spoon with an approximate volume capacity of 5 ml and the 2 mL tap water is added to the spoon.
  • the incubation time of the water for swelling and gelling is not more than 3 min until an administration is appropriately instructed.
  • Table 3 Tablet Compositions for suitable combinations of gel formers, tablets with 350 mg weight
  • Table 4 Tablet Compositions for suitable ranges of gel formers PO and CA, and wicking agent FR, tablets with 350 mg weight
  • Table 5 Tablet Compositions for suitable ranges of gel formers SP and CA, and wicking agent FR, tablets with 350 mg weight
  • the amount of water ingress is detected by KRUSS Tensiometer K100 Mk2 (Kriiss GmbH, Germany) with 80mL tap water at room temperature (20°C).
  • the water uptake of the excipients is determined with the Washburn method setup. lOOmg of the polymer powder was poured into a glass tube with a glass filter and carefully tapped for 5 times. The change in weight was recorded and interpreted as the amount of water absorption.
  • the gelling performance of the tablets was characterized using a Texture Analyzer TA-XT2i (Stable Micro Systems, UK).
  • the Texture analyzer is equipped with a 5 kg load cell, a flat- ended cylindrical probe of 7 mm in diameter is used, and the initial probe distance is set to 10 mm.
  • the tablets are swelled with 2mL of tap water for 30 seconds on a spoon then transferred to a glass slide or directly on a medical spoon for measurement at room temperature ( approx. 20°C).
  • the maximum force is set to 80 g, which is the maximum mouth force of a 2 year-old child, in the “Measure Distance in Compression” mode.
  • the indentation depth and total work of penetration is calculated.
  • the indentation depth is calculated by the percentage of the detected swelled height and the gelling height.
  • the total work of penetration is the integral of the traveled distance and the force applied during the measurement time.
  • the progression of gelling front is determined by the indentation distance into the tablet from the maximum force of the probe. After 30 sec incubation time in water the indentation depth of gel forming tablets with suitable fast gelling progression, should be at least 50%.
  • the total work of penetration is used describe the range of gel strength for the gel forming tablets identified to meet the targeted properties. The found values for the total work range from 2.47 to 11.04 mJ.
  • Rheometer Haake MARSII (Thermo Electron GmbH, Germany) is used to determine the rheological properties of the tablets.
  • the tablets were swelled with 2mL of tap water on a table spoon for 1 minute then carefully transferred to the measurement plate.
  • a cone plate geometry (20mm diameter cone with 2°, C20/2) is used, and the measurements were carried out following the regulatory tutorial for rheology proposed by Simoes et al. (Pharmaceutics 12.9 (2020): 820). The results were analyzed with the software HAAKE RheoWin Data Manager. All measurements were performed at 23 °C.
  • Viscosity at a shear rate of 50 Hz is at minimum 10 Pa*s to obtain a semi-solid gel system.
  • Shear viscosity at 50 Hz should be not less than approximately 10 Pa*s to avoid potential dose losses due spillages of liquid form during administration of the gelled preparation on the spoon.
  • Tablets containing 7.5% (m/m) wicking agents and a combination of 2 gel formers at concentrations as listed in Table 3 resulted in rapid uptake of water and a stable gel body, which does not disintegrate.
  • the results of the water uptake analysis determined with tensiometer using the ring holder show at least more than 50% increase within first 30 seconds and no major weight loss after 180 sec.
  • the combination of 5%PO with 5% Pectin is ideally combined with calcium silicate as wicking agent to obtain most stable gel body (Fig. 2).
  • the formulations identified show an advanced progression of a gelling as expressed by the results of the texture analyzer. After incubation with water for 30 seconds all formulations showed at least an indentation depth of 50% and the gel firmness at this timepoint is ranging between approx. 1.96 to 9.81 mJ(Table 6).
  • Example 2 Formulations with carrageenan and polyethylene oxide as gel formers, and highly porous calcium silicate as wicking agent
  • the indentation depth after 3 seconds is approx. 62% at minimum and the work of penetration ranges from 3.44 to 11.03 mJ.
  • the flow point is for all formulation below 20 kPa and the shear viscosity consistently above 10 Pa*s.
  • the stress at flow point is consistently at 15.2 at maximum and the shear viscosity 35 Pa*s at minimum (Table 8).
  • Example 3 Formulations with carrageenan and sodium polyacrylate as gel formers, and highly porous calcium silicate as wicking agent
  • Example 4 Formulations containing drug
  • Gel forming tablets may be used as vehicle for mixing after gelling with a drug product.
  • the tablets contain themselves a drug.
  • Formulations combining kappa- carrageenan with polyethylene oxide have shown to release the drug rapidly from the gelled body as shown in Figure 6 for the drugs acetaminophen and ibuprofen.
  • Table 10 shows the compositions of the formulation including 28.4% of drug substance equivalent to a dose of lOOmg in a tablet with a mass of 352mg.
  • Table 10 Compositions of drug containing tablet and vehicle tablet * drug substance used: acetaminophen and ibuprofen
  • the obtained properties of the gelled tablets are conform with the targeted characteristics in terms of indentation depth, work of penetration , flow point and shear viscosity at shown in Table 11.
  • the shear viscosity for drug containing tablets at the drug load of 28.4% is below 10 Pa*s but still above 5 Pa*s, which is regarded the lower limit for semi-solid behavior.

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  • Life Sciences & Earth Sciences (AREA)
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Abstract

La présente invention concerne des procédés et des utilisations pour la préparation d'une composition solide sèche en tant que précurseur pour une formation de corps de gel stable lors de l'ajout d'eau. L'invention concerne également les compositions obtenues à partir de ces procédés et utilisations. Lesdits corps de gel peuvent, par exemple, être utilisés dans des compositions pharmaceutiques pour administrer des substances médicamenteuses à des patients présentant des difficultés à avaler.
PCT/EP2024/074239 2023-09-01 2024-08-30 Nouveaux procédés de préparation de compositions semi-solides et leurs utilisations WO2025046044A1 (fr)

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EP23194881.1 2023-09-01

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5496563A (en) * 1991-08-30 1996-03-05 Showa Yakuhin Kako Co., Ltd. Dry gel composition
WO2004019901A2 (fr) * 2002-08-30 2004-03-11 Orchid Chemicals & Pharmaceuticals Ltd. Composition pharmaceutique a liberation prolongee
WO2005107713A2 (fr) 2004-05-11 2005-11-17 Egalet A/S Nouvelle forme dosifiee
US9511015B2 (en) * 2010-07-13 2016-12-06 Ultragenyx Pharmaceutical Inc. Methods and formulations for treating sialic acid deficiencies
US9622977B2 (en) * 2008-10-08 2017-04-18 Bioplus Life Sciences Pvt, Ltd. Sustained release drug delivery system
WO2022011341A1 (fr) 2020-07-10 2022-01-13 Adare Pharmaceuticals, Inc. Compositions pharmaceutiques orales pouvant gonfler

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5496563A (en) * 1991-08-30 1996-03-05 Showa Yakuhin Kako Co., Ltd. Dry gel composition
WO2004019901A2 (fr) * 2002-08-30 2004-03-11 Orchid Chemicals & Pharmaceuticals Ltd. Composition pharmaceutique a liberation prolongee
WO2005107713A2 (fr) 2004-05-11 2005-11-17 Egalet A/S Nouvelle forme dosifiee
US9622977B2 (en) * 2008-10-08 2017-04-18 Bioplus Life Sciences Pvt, Ltd. Sustained release drug delivery system
US9511015B2 (en) * 2010-07-13 2016-12-06 Ultragenyx Pharmaceutical Inc. Methods and formulations for treating sialic acid deficiencies
WO2022011341A1 (fr) 2020-07-10 2022-01-13 Adare Pharmaceuticals, Inc. Compositions pharmaceutiques orales pouvant gonfler

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
HANAWA T ET AL: "DEVELOPMENT OF PATIENT-FRIENDLY PREPARATION(II): PREPARATION AND CHARACTERIZATION OF CARRAGEENAN GEL CONTAINING POLYETHYLENE (OXIDE)", YAKUGAKU ZASSHI : JOURNAL OF THE PHARMACEUTICAL SOCIETY OF JAPAN, PHARMACEUTICAL SOCIETY OF JAPAN, vol. 120, no. 11, 1 November 2000 (2000-11-01), pages 1209 - 1216, XP008037245, ISSN: 0031-6903 *
PARKJI-SUDONG-HWAN OHMOONYOUNG CHANG, JOURNAL OF PHYSICAL THERAPY SCIENCE, vol. 28, no. 2, 2016, pages 442 - 445
POTTER, NANCY L.ROBERT SHORT, DYSPHAGIA, vol. 24, no. 4, 2009, pages 391 - 397
S. KLEIN: "The Use of Biorelevant Dissolution Media to Forecast the In Vivo Performance of a Drug", AAPS JOURNAL, vol. 12, no. 3, September 2010 (2010-09-01)
SIMOES ET AL., PHARMACEUTICS, vol. 12, no. 9, 2020, pages 820

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