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WO1999038496A1 - Produits pharmaceutiques a dissolution rapide - Google Patents

Produits pharmaceutiques a dissolution rapide Download PDF

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Publication number
WO1999038496A1
WO1999038496A1 PCT/GB1999/000317 GB9900317W WO9938496A1 WO 1999038496 A1 WO1999038496 A1 WO 1999038496A1 GB 9900317 W GB9900317 W GB 9900317W WO 9938496 A1 WO9938496 A1 WO 9938496A1
Authority
WO
WIPO (PCT)
Prior art keywords
dosage form
form according
drug
matrix
low density
Prior art date
Application number
PCT/GB1999/000317
Other languages
English (en)
Inventor
Harry Seagar
Original Assignee
R.P. Scherer Corporation
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 R.P. Scherer Corporation filed Critical R.P. Scherer Corporation
Priority to AU22918/99A priority Critical patent/AU2291899A/en
Publication of WO1999038496A1 publication Critical patent/WO1999038496A1/fr

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
    • A61K9/0012—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

Definitions

  • This invention relates to pharmaceutical products, and particularly to such products suitable for oral ingestion and capable of rapid disintegration in the oral cavity.
  • a large variety of dosage forms for oral ingestion are known and readily available .
  • Some such dosage forms are used for the controlled delivery and absorption of medicaments to different sites in the gastro-intestinal tract, the requisite control being achieved by the rate at which the carrier for the medicament breaks down and releases it.
  • fast dispersing carriers are used for such products in which the medicament is to be quickly released.
  • Slower dispersing carriers and carriers resistant to digestion in the gastro-intestinal tract can be used where it is intended that release of the medicament is to be delayed, for example until the product has itself reached the upper or lower intestine.
  • Some drugs are administered orally in the form of a tablet designed to be swallowed whole or a measured amount of a conventional syrup designated to be swallowed rapidly.
  • Drugs administered in this way are absorbed from the gastrointestinal tract, that is, the stomach, the small intestine and the proximal large intestine (colon) , into the hepatic portal system and are presented to the liver before reaching the systemic circulation.
  • the liver is known to be the principal site for conversion of drugs into metabolites, some of which are unwanted. Consequently, this first pass of absorbed drug through the liver results in extensive metabolism of the drug and a significant proportion of the absorbed dose never reaches the systemic circulation. This phenomenon is known as the "first pass effect" and results in a decrease in the bioavailability of drugs administered in this way (see Heinonen et al, Clinical Pharmacology & Therapeutics, 2
  • Certain drugs are hydrophobic and exhibit poor bioavailability when taken orally.
  • the present invention is concerned particularly with such drugs; ie, those not generally effectively absorbed after conventional oral ingestion. These drugs will be referred to hereinafter as "non- absorbed drugs” .
  • the aim of the present invention is to provide a means by which non-absorbed drugs can be taken orally, and targeted to appropriate sites to obtain their absorption pre-gastrically.
  • the target sites for drugs provided in dosage forms according to the invention are the mucosal surfaces in the mouth, pharynx and oesophagus. If a drug can achieve absorption at the pre-gastric target sites, then it avoid the destructive "first pass" via the liver. By achieving pre-gastric absorption they also avoid the stomach, and go straight to the circulatory tissue.
  • a dosage form comprises a solid, fast-dispersing or fast-dissolving matrix carrying a non-absorbed drug. This form provides for rapid release of the drug and its even distribution over the target sites.
  • the drug is particularly adapted for absorption at these sites.
  • the adapted drug can be borne in a fast-dispersing carrier, thereby taking advantage of such carriers, and ensuring that the drug is irrevocably dispersed in a patient's mouth, and in active contact with the target sites.
  • a principal step in one such adaptation is to provide the drug in 3 particulate form, and with a very low average particle size. In such embodiments of the invention a typical maximum particle size is 400 nanometers, although an average particle size of no greater than 100 nanometers would be preferred.
  • the particle surfaces may themselves be modified to improve the bioavailability of the drug, and examples of means by which the particle surfaces can be so modified are given in PCT Patent Publication Nos. O93/25190; W096/22766; 096/25921; and O97/04756.
  • the nanoparticle technology disclosed in these publications provides means by which the bioavailability of the drugs disclosed can be improved. We have found that by providing them in a dosage form comprising a fast-dispersing or fast-dissolving matrix, the adapted drug can disperse more uniformly and rapidly in the mouth and promote pre-gastric absorption.
  • This microsphere technology is itself known, and reference is directed to U.S. Patent No. 5540939, and PCT Publication Nos. WO94/23702; W094/28878; and WO96/09813.
  • This microsphere encapsulation option can also be taken up when the drug is provided in nanoparticulate form, as described above.
  • a third option for adapting drugs for incorporation into dosage forms of the invention is to convert the drug into a form which has better absorption characteristics, the drug adapting after the converted form has been absorbed, thereby releasing the drug at the target sites in its native form.
  • the converted form is an intermediate conformational state between its native and denatured state, in a supramolecular non-covalently bonded complex.
  • Certain drugs can be so converted by exposure to a complexing perturbant, as is described in PCT Publication No. W096/12475, to which once again, reference is directed. 4
  • This option has the additional advantage that in its converted form the drug can be more stable and better resist enzymatic degradation.
  • Coated microemulsions or microemulsion preconcentrates or liposomes can also be used to protect drugs from enzymatic degradation, and/or to enhance absorption of the drug in the target sites. It is preferred that dosage forms of the invention disintegrate within 1 to 60 seconds, more preferably 1 to 30 seconds, especially 1 to 10 seconds and particularly 2 to 8 seconds, of being placed in the oral cavity.
  • drugs and dosage forms according to the invention will also normally include a mucoadhesive element or substance.
  • Mucoadhesive technology is well established, and some suitable polymeric mucoadhesives are disclosed in PCT Publication No. WO94/20070.
  • Fast-dispersing dosage forms, delivered orally, have been demonstrated to rapidly disperse and coat the mucosal surfaces in the mouth, pharynx and oesophagus.
  • reference is directed to a paper by Wilson et al published in the International Journal of Pharmaceutics, 40 (1997) pages 119-123.
  • Figure 1 in that paper shows the results of a gamma scintigraphic study.
  • fast-dispersing dosage form improves the targeting of drugs to mucous membranes in the mouth, the pharynx and the oesophagus and in turn, the concentration of drug making contact with these tissues.
  • Fast-dispersing dosage forms increase the contact time with the target tissue in the buccopharyngeal and oesophagal area.
  • drugs are appropriately protected from digestion in the stomach and gut, rapidly dispersed materials will further promote absorption of any drug which reaches the small intestine.
  • U.S. Patent No. 5120549 discloses a fast-dispersing matrix system which is prepared by first solidifying a matrix-forming system dispersed in a first solvent and subsequently contacting the solidified matrix with a second solvent that is substantially miscible with the first solvent at a temperature lower than the solidification point of the first solvent, the matrix- forming elements and active ingredient being substantially insoluble in the second solvent, whereby the first solvent is substantially removed resulting in a fast-dispersing matrix.
  • a fast-dispersing dosage form which comprises a porous skeletal structure of a water soluble, hydratable gel or foam forming 6 material that has been hydrated with water, rigidified in the hydrated state with a rigidifying agent and dehydrated with a liquid organic solvent at a temperature of about 0°C or below to leave spaces in place of hydration liquid.
  • U.S. Patent No. 5587180 discloses a particulate support matrix for a tablet, and method for making same, which disintegrates or dissolves in just a few seconds once placed in the oral cavity.
  • the particulate support matrix comprises a first polymeric component which may be a polypeptide, a second polymeric component which may be a different polypeptide, and may be a hydrolyzed gelatin, and a bulking agent.
  • fast-dispersing dosage form therefore encompasses all the types of dosage form described in the preceding paragraphs.
  • the fast-dispersing dosage form is of the type described in U.K. Patent No. 1548022, that is, a solid fast-dispersing dosage form comprising a network 7 of the active ingredient and a water-soluble or water- dispersible carrier which is inert towards the active ingredient , the network having been obtained by subliming solvent from a composition in the solid state, that composition comprising the active ingredient and a solution of the carrier in a solvent.
  • the composition will preferably contain, in addition to the active ingredient, matrix forming agents and secondary components.
  • Matrix forming agents suitable for use in the present invention include materials derived from animal or vegetable proteins, such as the gelatins, dextrins and soy, wheat and psyllium seed proteins; gums such as acacia, guar, agar, and xanthan; polysaccharides; alginates; carboxymethylcelluloses; carrageenans; dextrans; pectins; synthetic polymers such as polyvinylpyrrolidone; and polypeptide/protein or polysaccharide complexes such as gelatin-acacia complexes.
  • matrix forming agents suitable for use in the present invention include sugars such as mannitol, dextrose, lactose, galactose and trehalose; cyclic sugars such as cyclodextrin; inorganic salts such as sodium phosphate, sodium chloride and aluminium silicates; and amino acids having from 2 to 12 carbon atoms such as a glycine, L-alanine, L-aspartic acid, - glutamic acid, L-hydroxyproline, L-isoleucine, -leucine and L-phenylalanine .
  • One or more matrix forming agents may be incorporated into the solution or suspension prior to solidification.
  • the matrix forming agent may be present in addition to a surfactant or to the exclusion of a surfactant.
  • the matrix forming agent may aid in maintaining the dispersion of any active ingredient within the solution or suspension. This is especially helpful in the case 8 of active agents that are not sufficiently soluble in water and must, therefore, be suspended rather than dissolved.
  • Suitable colouring agents include red, black and yellow iron oxides and FD & C dyes such as FD & C blue No. 2 and FD & C red No. 40 available from Ellis & Everard.
  • Suitable flavouring agents include mint, raspberry, liquorice, orange, lemon, grapefruit, caramel, vanilla, cherry and grape flavours and combinations of these.
  • Suitable pH modifiers include citric acid, tartaric acid, phosphoric acid, hydrochloric acid and maleic acid.
  • Suitable sweeteners include aspartame, acesulfame K and thaumatic.
  • Suitable taste-masking agents include sodium bicarbonate, ion-exchange resins, cyclodextrin inclusion compounds, adsorbates or microencapsulated actives.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une forme galénique pour administration orale comprenant une matrice solide, à dispersion ou à dissolution rapide, qui contient un médicament du type généralement difficilement absorbé à la suite d'une ingestion orale classique. Ces médicaments sont dénommés 'médicaments non absorbés'. La forme galénique de la présente invention permet une libération rapide du médicament avec une égale distribution entre les muqueuses de la bouche, du pharynx et de l'oesophage. Le médicament est particulièrement bien adapté à son absorption au niveau de ces sites. Le support à dissolution rapide assure la dispersion parfaite dudit médicament dans la bouche du patient, et, son contact actif avec les sites cibles, ce qui permet son absorption pré-gastrique.
PCT/GB1999/000317 1998-01-30 1999-01-29 Produits pharmaceutiques a dissolution rapide WO1999038496A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU22918/99A AU2291899A (en) 1998-01-30 1999-01-29 Fast dissolving pharmaceutical products

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB9802088.6A GB9802088D0 (en) 1998-01-30 1998-01-30 Pharmaceutical products
GB9802088.6 1998-01-30

Publications (1)

Publication Number Publication Date
WO1999038496A1 true WO1999038496A1 (fr) 1999-08-05

Family

ID=10826221

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1999/000317 WO1999038496A1 (fr) 1998-01-30 1999-01-29 Produits pharmaceutiques a dissolution rapide

Country Status (3)

Country Link
AU (1) AU2291899A (fr)
GB (1) GB9802088D0 (fr)
WO (1) WO1999038496A1 (fr)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009042114A2 (fr) 2007-09-21 2009-04-02 The Johns Hopkins University Dérivés de phénazine et leurs utilisations
US7700608B2 (en) 2004-08-04 2010-04-20 Shire Holdings Ag Quinazoline derivatives and their use in the treatment of thrombocythemia
US7910597B2 (en) 2006-11-28 2011-03-22 Shire Llc Substituted quinazolines
US8268349B2 (en) 2003-08-28 2012-09-18 Abbott Laboratories Solid pharmaceutical dosage form
US8377952B2 (en) 2003-08-28 2013-02-19 Abbott Laboratories Solid pharmaceutical dosage formulation
US8470347B2 (en) 2000-05-30 2013-06-25 AbbVie Deutschland GmbH and Co KG Self-emulsifying active substance formulation and use of this formulation
US9775819B2 (en) 2009-09-16 2017-10-03 R.P. Scherer Technologies, Llc Oral solid dosage form containing nanoparticles and process of formulating the same using fish gelatin
US10744086B2 (en) 2009-10-30 2020-08-18 Ix Biopharma Ltd. Fast dissolving solid dosage form
US11786508B2 (en) 2016-12-31 2023-10-17 Bioxcel Therapeutics, Inc. Use of sublingual dexmedetomidine for the treatment of agitation
US11806429B2 (en) 2018-06-27 2023-11-07 Bioxcel Therapeutics, Inc. Film formulations containing dexmedetomidine and methods of producing them
US11890272B2 (en) 2019-07-19 2024-02-06 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
US11998528B1 (en) 2023-01-12 2024-06-04 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
US12186426B2 (en) 2009-10-30 2025-01-07 Ix Biopharma Ltd. Solid dosage form

Citations (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4866046A (en) * 1988-05-31 1989-09-12 Top Laboratories, Inc. Low-dosage sublingual aspirin
EP0371466A1 (fr) * 1988-11-30 1990-06-06 Schering Corporation Comprimé buccal
WO1993023017A1 (fr) * 1992-05-06 1993-11-25 Janssen Pharmaceutica, Inc. Presentations pharmaceutiques et autres formes galeniques
US5384124A (en) * 1988-07-21 1995-01-24 Farmalyoc Solid porous unitary form comprising micro-particles and/or nano-particles, and its preparation
EP0651997A1 (fr) * 1991-12-24 1995-05-10 Yamanouchi Pharmaceutical Co. Ltd. Preparation se desagrageant dans la bouche et elaboration de cette preparation
WO1996009813A1 (fr) * 1994-09-29 1996-04-04 Emisphere Technologies, Inc. Systemes d'apport a base de dicetopiperazine
WO1996012475A1 (fr) * 1994-10-25 1996-05-02 Emisphere Technologies, Inc. Systemes de transport d'agent actif
EP0711547A1 (fr) * 1994-11-04 1996-05-15 Fuisz Technologies Ltd. Administration d'un système à libération contrÔlée avec matrice "shearform"
US5540939A (en) * 1992-12-21 1996-07-30 Emisphere Technologies, Inc. Modified hydrolyzed vegetable protein microspheres and methods for preparation and use thereof
WO1996022766A1 (fr) * 1995-01-24 1996-08-01 Nanosystems L.L.C. Tensioactifs sulfates copolymeres blocs non ioniques utilises comme revetements stabilisants pour des compositions a base de nanoparticules
WO1996025921A1 (fr) * 1995-02-24 1996-08-29 Nanosystems L.L.C. Copolymeres blocs de polyalkylene en tant que modificateurs de surface pour des nanoparticules
WO1996026720A1 (fr) * 1995-03-02 1996-09-06 R.P. Scherer Limited Compositions pharmaceutiques comportant des inhibiteurs de monoamine-oxydase b
WO1996033699A1 (fr) * 1995-04-28 1996-10-31 Emisphere Technologies, Inc. Microspheres d'acides diamide-dicarboxyliques
US5587180A (en) * 1994-01-27 1996-12-24 The Board Of Regents Of The University Of Oklahoma Process for making a particulate support matrix for making a rapidly dissolving tablet
WO1998006379A1 (fr) * 1996-08-08 1998-02-19 R.P. Scherer Limited Compositions pharmaceutiques

Patent Citations (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4866046A (en) * 1988-05-31 1989-09-12 Top Laboratories, Inc. Low-dosage sublingual aspirin
US5384124A (en) * 1988-07-21 1995-01-24 Farmalyoc Solid porous unitary form comprising micro-particles and/or nano-particles, and its preparation
EP0371466A1 (fr) * 1988-11-30 1990-06-06 Schering Corporation Comprimé buccal
EP0651997A1 (fr) * 1991-12-24 1995-05-10 Yamanouchi Pharmaceutical Co. Ltd. Preparation se desagrageant dans la bouche et elaboration de cette preparation
WO1993023017A1 (fr) * 1992-05-06 1993-11-25 Janssen Pharmaceutica, Inc. Presentations pharmaceutiques et autres formes galeniques
US5540939A (en) * 1992-12-21 1996-07-30 Emisphere Technologies, Inc. Modified hydrolyzed vegetable protein microspheres and methods for preparation and use thereof
US5587180A (en) * 1994-01-27 1996-12-24 The Board Of Regents Of The University Of Oklahoma Process for making a particulate support matrix for making a rapidly dissolving tablet
WO1996009813A1 (fr) * 1994-09-29 1996-04-04 Emisphere Technologies, Inc. Systemes d'apport a base de dicetopiperazine
WO1996012475A1 (fr) * 1994-10-25 1996-05-02 Emisphere Technologies, Inc. Systemes de transport d'agent actif
EP0711547A1 (fr) * 1994-11-04 1996-05-15 Fuisz Technologies Ltd. Administration d'un système à libération contrÔlée avec matrice "shearform"
WO1996022766A1 (fr) * 1995-01-24 1996-08-01 Nanosystems L.L.C. Tensioactifs sulfates copolymeres blocs non ioniques utilises comme revetements stabilisants pour des compositions a base de nanoparticules
WO1996025921A1 (fr) * 1995-02-24 1996-08-29 Nanosystems L.L.C. Copolymeres blocs de polyalkylene en tant que modificateurs de surface pour des nanoparticules
WO1996026720A1 (fr) * 1995-03-02 1996-09-06 R.P. Scherer Limited Compositions pharmaceutiques comportant des inhibiteurs de monoamine-oxydase b
WO1996033699A1 (fr) * 1995-04-28 1996-10-31 Emisphere Technologies, Inc. Microspheres d'acides diamide-dicarboxyliques
WO1998006379A1 (fr) * 1996-08-08 1998-02-19 R.P. Scherer Limited Compositions pharmaceutiques

Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8470347B2 (en) 2000-05-30 2013-06-25 AbbVie Deutschland GmbH and Co KG Self-emulsifying active substance formulation and use of this formulation
US8268349B2 (en) 2003-08-28 2012-09-18 Abbott Laboratories Solid pharmaceutical dosage form
US8309613B2 (en) 2003-08-28 2012-11-13 Abbvie Inc. Solid pharmaceutical dosage form
US8333990B2 (en) 2003-08-28 2012-12-18 Abbott Laboratories Solid pharmaceutical dosage form
US8377952B2 (en) 2003-08-28 2013-02-19 Abbott Laboratories Solid pharmaceutical dosage formulation
US8399015B2 (en) 2003-08-28 2013-03-19 Abbvie Inc. Solid pharmaceutical dosage form
US8691878B2 (en) 2003-08-28 2014-04-08 Abbvie Inc. Solid pharmaceutical dosage form
US7700608B2 (en) 2004-08-04 2010-04-20 Shire Holdings Ag Quinazoline derivatives and their use in the treatment of thrombocythemia
US7910597B2 (en) 2006-11-28 2011-03-22 Shire Llc Substituted quinazolines
WO2009042114A2 (fr) 2007-09-21 2009-04-02 The Johns Hopkins University Dérivés de phénazine et leurs utilisations
US9775819B2 (en) 2009-09-16 2017-10-03 R.P. Scherer Technologies, Llc Oral solid dosage form containing nanoparticles and process of formulating the same using fish gelatin
US10744086B2 (en) 2009-10-30 2020-08-18 Ix Biopharma Ltd. Fast dissolving solid dosage form
US11975097B2 (en) 2009-10-30 2024-05-07 Ix Biopharma Ltd. Fast dissolving solid dosage form
US12186426B2 (en) 2009-10-30 2025-01-07 Ix Biopharma Ltd. Solid dosage form
US11786508B2 (en) 2016-12-31 2023-10-17 Bioxcel Therapeutics, Inc. Use of sublingual dexmedetomidine for the treatment of agitation
US11839604B2 (en) 2016-12-31 2023-12-12 Bioxcel Therapeutics, Inc. Use of sublingual dexmedetomidine for the treatment of agitation
US11931340B2 (en) 2016-12-31 2024-03-19 Bioxcel Therapeutics, Inc. Use of sublingual dexmedetomidine for the treatment of agitation
US11806429B2 (en) 2018-06-27 2023-11-07 Bioxcel Therapeutics, Inc. Film formulations containing dexmedetomidine and methods of producing them
US11890272B2 (en) 2019-07-19 2024-02-06 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
US11998529B2 (en) 2019-07-19 2024-06-04 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
US12109196B2 (en) 2019-07-19 2024-10-08 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
US11998528B1 (en) 2023-01-12 2024-06-04 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens

Also Published As

Publication number Publication date
GB9802088D0 (en) 1998-03-25
AU2291899A (en) 1999-08-16

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