WO2020212829A1 - Formes galéniques uniques pharmaceutiques à composants multiples et leurs procédés d'utilisation - Google Patents

Formes galéniques uniques pharmaceutiques à composants multiples et leurs procédés d'utilisation Download PDF

Info

Publication number
WO2020212829A1
WO2020212829A1 PCT/IB2020/053482 IB2020053482W WO2020212829A1 WO 2020212829 A1 WO2020212829 A1 WO 2020212829A1 IB 2020053482 W IB2020053482 W IB 2020053482W WO 2020212829 A1 WO2020212829 A1 WO 2020212829A1
Authority
WO
WIPO (PCT)
Prior art keywords
piece
dosage form
single dosage
component pharmaceutical
drug substance
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IB2020/053482
Other languages
English (en)
Inventor
Amruth Gowda Doddaveerappa
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2020212829A1 publication Critical patent/WO2020212829A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms

Definitions

  • the present disclosure relates generally to the field of tablet formulations
  • the present disclosure is related to multi-component pharmaceutical single dosage forms and methods employed thereof.
  • the multi-component pharmaceutical single dosage forms disclosed herein comprise a plurality of tablet sub-units, a body piece and a cap.
  • oral dosage forms have been developed over the years and the more popular oral dosage forms are tablets, capsules and gelcaps. Tablets are compressed or molded solid dosage forms of various sizes or various shapes. Oblong-shaped tablets may sometimes be referred to as caplets. Tablets remain popular with consumers, however uncoated tablets suffer from drawbacks such as medicinal taste, a tendency to powder or flake (i.e., physical disintegration) when packaged in bottles, and/or the perception by consumers that they are not easy to swallow. These limitations are overcome by coating the tablets with a polymeric coating.
  • Hard gelatin capsules are popular dosage forms consisting of two halves, a body and a cap. Over the years these hard gelatin capsules are used to deliver medicament in the form of powder, liquid or suspension form. Soft gelatin capsules are the dosage forms made of gelatin films and are used to deliver medicament in liquid or suspension form.
  • Enrobed tablets are the dosage forms wherein solid tablet core is enrobed in soft elastic film material such as a gelatin film has significant advantages like tamper evident and ease of swallowing making it one of the most desired dosage form.
  • the enrobed tablets can be further processed to have enteric coatings for acid resistant properties and also the enrobed tablet can be enrobed to have significantly more strength and resistance to breakage during handling.
  • Several times while formulating some APIs in tablet dosage form we come across several challenges like variation in dissolution, drug stability and bioavailability issues. Further, tablets require very high compaction forces for formation.
  • Hard gelatin capsules offer distinct advantages over tablets like the powder containing active substance can be filled into capsules with very little compaction or un-compacted, compared to tablet. Also pellets or mini tablets can be filled into the capsules. Capsules require lesser amounts of disintegrants and lubricants compared to tablets due to lower compacted powder mass. Many times direct mixing and filling into capsules minimize scale up issues in commercial production. Often capsule dosage form can offer better bioavailability and less scale up issues.
  • An objective of the present disclosure is directed towards providing a multi- component pharmaceutical actives in a single unit of dosage form i.e., multi-component pharmaceutical single dosage forms.
  • An objective of the present disclosure is directed towards providing a method of preparing multi-component pharmaceutical single dosage forms wherein the multi- component pharmaceutical single dosage forms comprise at least two tablet sub-units, a body and a cap
  • An objective of the present disclosure is directed towards providing various possible methods of sealing a body filled with powder with active drug substance and various forms of medicament (pellets, mini tablets, granules etc) incorporated in the dosage form of invention. Use of sealing agents to improve sealing is also disclosed herein.
  • Another objective of the present disclosure is directed towards machines used for manufacturing of the multi-component pharmaceutical single dosage forms containing atleast two pieces comprising a body and a cap
  • Another objective of the present disclosure is directed towards different capsule like multi-component pharmaceutical single dosage form offering advantages of capsule formulations.
  • Another objective of the present disclosure is directed towards multi-component pharmaceutical single dosage form comprising placebo blend for body piece compressed in a tablet press with suitable punches and subsequently filled with powder form of active drug substances into the placebo body piece.
  • the pre-compressed placebo cap piece is placed over body. Cap and body pieces are joined by pressing.
  • a sealing agent having adhesive properties such as polymer or non-polymer in solvent can be applied to the cap surfaces coming in contact with placebo body piece to improve sealing strength.
  • Another objective of the present disclosure is directed towards multi-component pharmaceutical single dosage form providing advantages like improving patient compliance by masking taste and odour.
  • the multi-component pharmaceutical single dosage form may be extended release or immediate release tablets.
  • a multi-component pharmaceutical single dosage form comprising: a plurality of sub-units comprising a body piece and a cap piece, wherein the body piece is a capsule shaped tablet piece filled with an active drug substance blend, and the cap piece compressed in pre-determined dimensions with suitable punches and attached to provide the multi-component pharmaceutical single dosage form.
  • FIG. 1 is a diagram 100 depicting a pictorial representation of multi-component pharmaceutical single dosage form comprising compression of placebo body piece, in accordance with one or more exemplary embodiments.
  • FIG. 2 is a diagram 200 depicting a multi-component pharmaceutical single dosage form related to filling of powder with active drug substance into placebo body piece, in accordance with one or more exemplary embodiments.
  • FIG. 3 is a diagram 300 depicting compression of placebo cap piece for a multi- component pharmaceutical single dosage form, in accordance with one or more exemplary embodiments.
  • FIG. 4 is a diagram 400 depicting placing of placebo cap onto placebo body filled with powder with active drug substance, in accordance with one or more exemplary embodiments.
  • FIG. 5 is a diagram 500 depicting a sealing of cap and body to form a multi- component pharmaceutical single dosage form, in accordance with one or more exemplary embodiments.
  • FIG. 6 is a diagram 600 depicting different placebo cap designs for multi-component pharmaceutical single dosage form, in accordance with one or more exemplary embodiments.
  • tablet unit/tablet sub-units refer to the tablet units that comprise the multi- component pharmaceutical single dosage form. As disclosed herein sub-units/units or table subunits, a body piece and a cap comprise the multi-component pharmaceutical single dosage form.
  • FIG.l represented by 100 is the placebo blend for body piece of the multi-component pharmaceutical single dosage form compressed with punches and specifically designed to form a capsule body shaped tablet piece as shown in FIG. 1.
  • a capsule body shaped tablet piece can be prepared in various shapes and sizes.
  • Placebo blend used for compression of body piece 101 comprises of at least one pharmaceutical diluent and a lubricant.
  • the placebo blend optionally may comprise of a disintegrant, colorant, antiadherent.
  • the placebo for body piece comprise of a lubricant to facilitate compression process.
  • the placebo blend for body piece may also comprise other ingredients such as a disintegrant to facilitate disintegration of the dosage form such as Crospovidone, Croscarmellose sodium, Sodium starch glycolate, a lubricant such as Magnesium stearate, Sodium stearyl fumarate, stearic acid, and calcium stearate. Further optionally excipients such as binders, glidants, and wetting agents may be incorporated into the body piece. Diluent such as Lactose, microcrystalline cellulose, starch or dicalcium phosphate can be used.
  • FIG. 2 is a diagram 200 depicting a multi-component pharmaceutical single dosage form related to filling of powder with active drug substance into placebo body piece, in accordance with one or more exemplary embodiments.
  • the placebo body piece is filled with a powder with active drug substance 202 as shown in FIG. 2.
  • the powder with active drug substance 202 may comprise of an active drug substance and at least one pharmaceutical excipient.
  • FIG. 3 is a diagram 300 depicting compression of placebo cap piece for a multi-component pharmaceutical single dosage form, in accordance with one or more exemplary embodiments.
  • a placebo cap is compressed in pre-determined dimensions with suitable punches in another tablet press as shown in FIG. 3.
  • the cap portions coming in contact with body portion can be applied with sealing agent.
  • a sealing agent may comprise of polymer or non-polymer substance having adhesive properties and dispersed or dissolved in solvent.
  • the cap is then transported and placed over the body piece filled with powder with active substance.
  • 303a and 303b represents placebo caps while 304 represent the adhesive layer.
  • FIG.S 4 and FIG.5 are diagrams 400 and 500 respectively;
  • FIG.4 represented by 400 depicts placing of placebo cap onto placebo body filled with powder with active drug substance.
  • 401 is the placebo body
  • 402 is the powder with active and 403a is placebo cap.
  • FIG.5 represented by 500 represents sealing of a cap and a body to form multi-component pharmaceutical single dosage form.
  • 501 is the placebo body
  • 502 is the powder with active and 503a is placebo cap.
  • the cap is pressed so that body and cap is tightly held as shown in FIG. 4 and FIG. 5.
  • the cap may be compressed in various sizes and shapes suitable for the body piece. Excipients used for compression of placebo body piece can be used for compression of cap piece.
  • FIG. 6 is a diagram 600 depicting different placebo cap designs for multi-component pharmaceutical single dosage form, in accordance with one or more exemplary embodiments.
  • 601 is placebo body
  • 602 is powder with active
  • 603a, 603b and 604 represent placebo caps in different shapes/configurations.
  • a pre-formed placebo cap can also be used to seal the body piece which contains at least one pharmaceutical excipient.
  • the pre-formed placebo cap can be further embedded with an adhesive ingredient on one surface which upon coming in contact with slight moisture can be adhered to body piece.
  • placebo body piece and cap piece may be incorporated with active substance based on requirement.
  • Pre-formed cap can also be coated with film coatings containing polymers such as Flydroxypropylmethyl cellulose to provide adhesive properties for attaching it to body piece upon contact with solvents such as water, alcohol etc.
  • the powder with active drug substance in the dosage form of invention can be replaced with medicament in the form of pellets or mini tablets or tablets or any other suitable form.
  • the diluent may include not limiting to calcium carbonate, calcium phosphate dibasic, calcium phosphate tribasic, calcium sulfate, silicified microcrystalline, cellulose acetate, sugar, dextrates, dextrin, dextrose, fructose, glyceryl palmitostearate, hydrogenated vegetable oil type I, isomalt, kaolin, lactitol, lactose, mannitol, magnesium carbonate, magnesium oxide, maltodextrin, maltose, mannitol, microcrystalline cellulose, polydextrose, sorbitol, starch, starch pregelatinized, sucrose, xylitol.
  • the lubricant may include not limiting to magnesium stearate, Sodium stearyl fumarate, stearic acid, calcium stearate, sodium stearyl fumarate and polyethylene glycols. Further optionally excipients such as binders, glidants, antiadherents, wetting agents may be incorporated into the body piece.
  • the placebo blend for body piece may also comprise other ingredients such as a disintegrant to facilitate disintegration of the dosage form such as Crospovidone, Croscarmellose sodium, Sodium starch glycolate, Low substituted hydroxyproyl cellulose, Carboxymethylcellulose calcium, starches, preglatinized starch.
  • a disintegrant to facilitate disintegration of the dosage form such as Crospovidone, Croscarmellose sodium, Sodium starch glycolate, Low substituted hydroxyproyl cellulose, Carboxymethylcellulose calcium, starches, preglatinized starch.
  • the capsule shaped body piece is filled with active drug substance blend which may be in the form of powder, granules, immediate release pellets, enteric coated pellets, mini tablets as shown in FIG. 2. Further various forms of active substance blend may comprise of atleast one active drug substance and at least one pharmaceutical excipient.
  • various forms of active substance blend such as powders, granules, immediate release pellets, enteric coated pellets, mini tablets used for the preparation of the dosage form of invention may include any of the active ingredients given here not limiting to Anastrozole, Alendronate Sodium, Atorvastatin, Aciclovir, Aspirin, Amitriptyline, Amoxicillin, Amlodipine Besylate, Albuterol, Alprazolam, Atenolol, Azithromycin, Allopurinol, Flydrochlorothiazide, Acyclovir, Amiodarone Flydrochloride, Atomoxetine Flydrochloride, Acetaminophen, Aripiprazole, Amoxicillin, Ambroxol, Atorvastatin, Bisoprolol, Bupropion, Baclofen, Bisoprolol Fumarate, Benztropine Mesylate, Benazepril Flydrochloride, Buspirone Fly
  • Hydrochlorothiazide Haloperidol, Hydralazine Hydrochloride, Hydroxychloroquine Sulfate, Hydromorphone Hydrochloride, Isoniazid, Itraconazole, Irbesartan, Ibuprofen, Isosorbide Mononitrate, Ketorolac, Fevocetirizine, Fevothyroxine, Fevofloxacin, Fisinopril, Fovastatin, Fevodopa, Foperamide, Fosartan Potassium, Fevetiracetam, Forazepam, Foratadine, Fabetalol, Famotrigine, Finagliptin, Fansoprazole, Foperamide, Metronidazole, Methylphenidate, Meloxicam, Metoclopramide Hydrochloride, Mirtazapine, Metoprolol, Metformin Hydrochloride, Memantine Hydrochloride, Metformin
  • compositions used for preparation of active substance blend may comprise of a diluent, a binder, a glidant, a disintegrant, lubricant etc.
  • a sealing agent may comprise of atleast one adhesive agent and one solvent.
  • a sealing agent may include not limiting to acacia, carbomers, gelatin, guar gum, dextrin, hydroxypropyl starch, liquid glucose, magnesium aluminium silicate, sodium alginate, zein, Povidone, co povidone, Hypromellose, hydroxypropyl cellulose, carboxymethyl cellulose.
  • solvents for preparation sealing agent may include not limiting to water or organic solvents such as Iso-propyl alcohol, Ethanol, acetone, Acetic acid, Ethyl acetate, Triethylamine, Dimethyl sulfoxide etc may be used individually or in combination.
  • the compressed cap is transported and placed over the body piece filled with active drug substance blend.
  • a pre-formed placebo cap can also be used to seal the body piece which contains at least one pharmaceutical excipient.
  • the pre-formed placebo cap can be further embedded with an adhesive ingredient on one surface which upon coming in contact with slight moisture can be adhered to body piece.
  • placebo body piece and cap piece may be incorporated with active substance based on requirement.
  • the powder form of active substance blend in the dosage form of invention can be replaced with other forms such as granules, pellets or mini tablets or any other suitable form.
  • Microcrystalline cellulose, lactose monohydrate and magnesium stearate are sifted separately. Microcrystalline cellulose and Lactose monohydrate are mixed. To this Magnesium stearate is added and mixed. Blend is taken for compression in tablet in tablet compression machine.
  • Ramipril and Hydroxypropylmethyl cellulose are sifted and mixed. To this dry mix purified water is added and granulated. Wet mass is dried and sifted. Ramipril granules are mixed with presifted Amlodipine and Pregelatinized starch. This blend is taken for filling.
  • One of the compression machine is fixed with 10 mm Flat, plain upper punches and 10 mm Flat lower punches. In this machine cap piece (lid piece) is compressed.
  • the other compression machine is fixed with special tooling to compress cup like tablet.
  • Upper punch with 10.1 mm outer diameter with 6 mm flat, plain tip with 6 mm deep is used.
  • 10.1 mm Flat, plain lower punches are used.
  • Cap piece is compressed in first rotary compression machine. Simultaneously Cup like tablet body piece is compressed in second rotary compression machine. In to this cup like tablet body piece Ramipril and amlodipine granules were filled. Compressed Cap piece is applied with sealing agent and then placed over cup like tablet body piece. Mechanical pressure is applied on to Cap piece to attach it to body piece. After attachment the dosage form of invention is ejected from the compression machine.
  • a multi-component pharmaceutical single dosage form may comprise the body piece or cap piece comprising at least one diluent and one lubricant and may not contain active drug substance.
  • a multi-component pharmaceutical single dosage form comprising: a plurality of sub-units comprising a body piece and a cap piece, wherein the body piece is a capsule shaped tablet piece filled with an active drug substance blend, and the cap piece compressed in pre-determined dimensions with suitable punches and attached to provide the multi-component pharmaceutical single dosage form.
  • the multi-component pharmaceutical single dosage form comprising a compressed cap piece having adhesive properties or applied with binder for adhesive properties is placed over the capsule shaped tablet piece filled with the active drug substance blend and mechanically attached to form a tablet dosage form.
  • the multi-component pharmaceutical single dosage form comprising the active drug substance blend comprise at least one of: an active drug substance and a pharmaceutical excipient.
  • the multi-component pharmaceutical single dosage form comprising the body piece or cap piece comprise at least one diluent and one lubricant and optionally contain active drug substance.
  • the multi-component pharmaceutical single dosage form comprising the capsule shaped tablet piece is filled with the active drug substance blend is selected from a group comprising at least one of: a powder form; granules form; immediate release pellets; enteric coated pellets; mini tablets and combinations thereof.
  • the multi-component pharmaceutical single dosage form comprising the active drug substance blend comprises of a diluent, a binder, a glidant, a disintegrants and a lubricant.
  • the multi-component pharmaceutical single dosage form comprising the compressed cap piece and the capsule shaped tablet piece are joined by a sealing agent having adhesive properties applied to the compressed cap piece surface in contact with the capsule shaped tablet piece.
  • a process of preparing a multi-component pharmaceutical single dosage form comprising:
  • Step a) preparing a capsule shaped tablet piece filled with a powder selected from an active drug substance blend
  • Step b) compressing a cap piece in pre-determined dimensions with suitable punches
  • Step c) placing the compressed cap piece over the capsule shaped tablet piece filled with the powder selected from the active drug substance blend and compressing the compressed cap piece and the capsule shaped tablet piece filled with the powder selected from the active drug substance blend to provide the multi-component pharmaceutical single dosage form.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Des exemples de modes de réalisation de la présente invention concernent des formes galénique uniques pharmaceutiques à composants multiples et leurs procédés d'utilisation. La forme galénique unique pharmaceutique à composants multiples comprend : une pluralité de sous-unités comprenant une pièce de corps et une pièce de capuchon, la pièce de corps étant une pièce de comprimé en forme de capsule ou de coupelle remplie d'une poudre choisie à partir d'un mélange de substances de médicament actif, et la pièce de capuchon comprimée dans des dimensions prédéterminées avec des poinçons appropriés pour fournir la forme galénique unique pharmaceutique à composants multiples. L'avantage de la forme galénique décrite ici est que le mélange de principes actifs n'est pas soumis à des forces de compression de comprimé. De plus, les concentrations de lubrifiant, de liant ou de délitant requises dans le mélange sont inférieures à celles des formes galéniques de comprimés classiques. Ceux-ci offrent un meilleur procédé de mise à l'échelle avec moins de problèmes de qualité.
PCT/IB2020/053482 2019-04-17 2020-04-14 Formes galéniques uniques pharmaceutiques à composants multiples et leurs procédés d'utilisation Ceased WO2020212829A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201941015483 2019-04-17
IN201941015483 2019-04-17

Publications (1)

Publication Number Publication Date
WO2020212829A1 true WO2020212829A1 (fr) 2020-10-22

Family

ID=72837745

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2020/053482 Ceased WO2020212829A1 (fr) 2019-04-17 2020-04-14 Formes galéniques uniques pharmaceutiques à composants multiples et leurs procédés d'utilisation

Country Status (1)

Country Link
WO (1) WO2020212829A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002060385A2 (fr) * 2001-01-30 2002-08-08 Smithkline Beecham Plc. Formulation pharmaceutique
US20140044784A1 (en) * 2011-03-15 2014-02-13 Boryung Pharmaceutical Co., Ltd Combined formulation with improved stability
US8673350B2 (en) * 2003-07-21 2014-03-18 Capsugel Belgium Nv Pharmaceutical formulations

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002060385A2 (fr) * 2001-01-30 2002-08-08 Smithkline Beecham Plc. Formulation pharmaceutique
US8673350B2 (en) * 2003-07-21 2014-03-18 Capsugel Belgium Nv Pharmaceutical formulations
US20140044784A1 (en) * 2011-03-15 2014-02-13 Boryung Pharmaceutical Co., Ltd Combined formulation with improved stability

Similar Documents

Publication Publication Date Title
JP6129295B2 (ja) 硬カプセル中にカプセル化された複数単位球状錠剤（ｍｕｓｔ）を含む複合製剤およびこれらの製造方法
KR101616246B1 (ko) 약제학적 투여형
US20080014228A1 (en) Solid form
US20080286344A1 (en) Solid form
US20080286343A1 (en) Solid form
TW200427448A (en) Controlled release preparations comprising tramadol and topiramate
WO2008140460A1 (fr) Forme solide
RS54929B1 (sr) Formulacija i metod obložene tablete
JP6313343B2 (ja) 有機化合物の製剤
WO2008140461A1 (fr) Forme solide
JP5756651B2 (ja) カンデサルタンシレキセチルを安定化した組成物及びその製造方法
CN106456640B (zh) 色瑞替尼制剂
WO2020212829A1 (fr) Formes galéniques uniques pharmaceutiques à composants multiples et leurs procédés d'utilisation
TWI566786B (zh) 含有氫化嗎啡酮鹽酸鹽之經口用徐放性醫藥組成物
WO2020212822A1 (fr) Formes posologiques pharmaceutiques mono doses à éléments multiples et procédé associé
AU2020202056B2 (en) Dosage form providing prolonged release of tapentadol phosphoric acid salt
WO2020255097A1 (fr) Procédé de production de formulations de comprimés à unités multiples
EP4003318A1 (fr) Forme posologique assurant une libération prolongée de sel d'acide phosphorique de tapentadol
JP7786701B2 (ja) 腸溶性の粒状物及びそれを含有する固形製剤
AU2020100442A4 (en) Dosage form providing prolonged release of tapentadol phosphoric acid salt
CA2545513C (fr) Forme de preparation pharmaceutique solide
JP6858873B2 (ja) セレコキシブを含む錠剤
WO2025216283A1 (fr) Composition pharmaceutique contenant du létermovir et son procédé de production et son utilisation
AU2021201353B1 (en) Dosage form providing prolonged release of a salt of Tapentadol with L-(+)-tartaric acid
JP2013119540A (ja) 固形医薬組成物およびその製造法

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20791299

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 20791299

Country of ref document: EP

Kind code of ref document: A1