EP1343481A2 - Procede de preparation d'une forme posologique rapidement soluble - Google Patents

Procede de preparation d'une forme posologique rapidement soluble

Info

Publication number
EP1343481A2
EP1343481A2 EP01270300A EP01270300A EP1343481A2 EP 1343481 A2 EP1343481 A2 EP 1343481A2 EP 01270300 A EP01270300 A EP 01270300A EP 01270300 A EP01270300 A EP 01270300A EP 1343481 A2 EP1343481 A2 EP 1343481A2
Authority
EP
European Patent Office
Prior art keywords
drugs
process according
dosage form
group
sodium
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.)
Withdrawn
Application number
EP01270300A
Other languages
German (de)
English (en)
Other versions
EP1343481A4 (fr
Inventor
Deepak Murpani
Rajiv Malik
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.)
Ranbaxy Laboratories Ltd
Original Assignee
Ranbaxy Laboratories Ltd
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 Ranbaxy Laboratories Ltd filed Critical Ranbaxy Laboratories Ltd
Publication of EP1343481A2 publication Critical patent/EP1343481A2/fr
Publication of EP1343481A4 publication Critical patent/EP1343481A4/fr
Withdrawn legal-status Critical Current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
    • A61K9/0012—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

  • the present invention relates to a process for the preparation of fast dissolving dosage form, such as tablet, which disintegrates quickly in the mouth.
  • the process of this invention is particularly suitable for moisture sensitive, poorly compressible and bitter drugs having a taste mask coating.
  • Fast disintegrating tablets are known to be prepared by tablet molding, spray drying, vacuum drying and freeze drying techniques, to name a few.
  • Currently available fast disintegrating tablets have several limitations such as poor physical integrity; insufficient taste masking; requirement of careful packaging and handling; sensitivity to humidity and temperature; unpleasant mouth-feel; difficulty in high drug loading; requirement of special equipment like freeze dryer or spray dryer; use of expensive or time consuming processing; and need for special packaging material or equipment.
  • U.S. Pat. No. 5,466,464 describes a process, using an agar solution as a binding agent and a blister - packaging well as a mold to prepare an intra- buccal fast-disintegrating tablets.
  • the process involves the preparation of a suspension containing active, agar and sugars, filling the suspension into the well, solidifying at room temperature and drying at 30 Q C under a pressure of 700 to 760mm Hg.
  • U.S. Pat. No. 5,298,261 describes a vacuum drying process to prepare rapidly disintegrating tablets. Vacuum drying a frozen mixture containing a gum, carbohydrates and a solvent in a tablet shaped mold produced tablets with enhanced structural integrity compared with that of traditional molded tablets. However, there is always a risk of residual solvents in the tablets prepared by this method.
  • Spray drying technique described in U.S. Pat. Nos. 5,587,180; 5,595,761 , 5,635,210 and 5,807,576 is another technique used to prepare fast dissolving tablets.
  • These formulations incorporated hydrolyzed and non- hydrolyzed gelatin as support agents, mannitol as a bulking agent, sodium starch glycolate or croscarmellose sodium as a disintegrant, and an effervescent couple to enhance disintegration and dissolution. Tablets made from the spray dried powder disintegrate within 20 seconds when immersed in an aqueous medium.
  • U.S. Pat. No. 5,576,014 describes a fluidized-bed granulation technology for WOWTAB quick-dissolving, without water tablets.
  • U.S. Pat. Nos. 4,305,502; 4,371 ,516; 5,738,875 use lyophilization (freeze drying) process to make an amorphous, porous structure which dissolves rapidly.
  • the principle of this technology (Zydis, technology) consists of preparing an aqueous suspension of the active ingredient and the excipients, which is dispensed into blister packs and water is removed by a freeze drying process. The final product is obtained by sealing the dried product in special peel-off blister packs.
  • the effectiveness of a freeze-drying process depends on the physico-chemical parameters of active substances used.
  • 6,083,531 describes an improved technique for preparing a rapidly dispersing tablet by preparing a suspension or solution of the active ingredient by dispersing or dissolving it in a solvent together with all other components of the composition and dispensing into molds e.g. blisters and then drying either by simple storage at room temperature or at elevated temperatures or by microwave radiation either at normal pressure or at reduced pressure.
  • molds e.g. blisters
  • microwave radiation either at normal pressure or at reduced pressure.
  • U.S. Pat. No. 5,853,758 provides a method for the preparation of a tablet of increased strength which comprises the steps of (a) combining and compressing a meltable binder and the active agent into a tablet (b) melting said binder in the tablet and (c) solidifying the binder by cooling. Further, volatile substances are added to increase the porosity. Method provides better hardness and friability but increases the disintegration time.
  • the present invention addresses the drawbacks and problems associated with the currently available technologies. It avoids the use of expensive and non-conventional equipment like freeze dryer or spray dryers. It also avoids the time consuming conventional process like compression.
  • the present invention relates to a process of preparing fast dissolving dosage form for oral administration, comprising the steps of a. Blending a pharmaceutically active ingredient, a cementing agent and optionally, together with other pharmaceutical excipients;
  • the process of the present invention is simple as it requires less number of steps than required in the conventional tabletting methods and is suitable for broad range of active ingredients with varying physico-chemical properties. It is particularly suitable for moisture sensitive drugs because the process does not involve the use of any solvent medium. It is also suitable for the poorly compressible drugs, as the binding is provided by fusion with cementing agent rather than compression; and the bitter drugs having a taste mask coat because the process does not involve compression leaving the coating intact.
  • the final dosage form is at least as free of residual solvents as the starting active ingredient. Furthermore, as the dosage form is made in-situ in the mold/final pack, the low hardness and high friability problems normally associated with the fast dissolving dosage forms do not arise.
  • the dosage form prepared by the present invention does not require any special packing like "peel on” etc. It has sufficient mechanical strength to withstand the usual press through pack (blister packaging).
  • the present invention provides a process for preparing a solid pharmaceutical dosage form adapted for direct usual administration into the mouth, which is particularly useful for improving compliance in geriatric and pediatric patients who have difficulty in swallowing.
  • the cementing agent of the present invention provides cohesive properties to the powdered material on heating and thereby fuses the powder blend when allowed to cool to make the tablets in-situ. Further, it ensures that the tablet remains intact.
  • the cementing agent of the present invention can be selected from the excipients well known in the art. Preferably, it is selected from the pharmaceutical binders which melt on heating.
  • the preferred cementing agent of the present invention melts at a temperature ranging from about 20 S C to about 100 Q C, preferably from about 40 Q C to about 60 9 C.
  • the cementing agent of the present invention may include fats such as lanolin, lanolin alcohol, hydrous lanolin; natural waxes such as carnuba wax; natural or synthetic polymers such as polyethylene glycols (PEGs); maltodextrins; and sugars such as dextrose and xylitol.
  • fats such as lanolin, lanolin alcohol, hydrous lanolin
  • natural waxes such as carnuba wax
  • natural or synthetic polymers such as polyethylene glycols (PEGs); maltodextrins
  • sugars such as dextrose and xylitol.
  • the cementing agent is selected in a way such that it melts at a temperature lower than the decomposition temperature of the pharmaceutically active agent and excipients present.
  • the preferable cementing agents of this invention are PEGs, having molecular weights ranging from 200 to 20,000; preferably from 1000 to 8000. Solid PEGs are preferred. Mixture of PEGs of different molecular weights or a mixture of liquid and solid grade PEGs are also contemplated. A structural body having desired hardness and disintegration / dissolution rate can be obtained regardless of their mixing ratio. However, such a structure of interest can not be obtained with usual pharmaceutical binders such as polyvinylpyrrolidone, xanthan gum, guar gum and the like, if used alone. However, they can be used together with PEGs to increase the cohesiveness.
  • the polyethylene glycol forms the desired shape because it melts on heating and therefore fuse all the components of the dosage form when allowed to cool acquire the shape of the mold/pack.
  • Different molecular weight PEGs can be combined to give good dispersibility and solubility.
  • the concentration and molecular weight may vary depending upon the active ingredient and the desired hardness, the PEGs may be used in the inventive process in a concentration of upto 90 w/w%, preferably 20 w/w% or more, based on the total weight of the dosage form.
  • the cementing agent may be combined with the other excipients and the pharmaceutically active agent in any sequence.
  • the excipients of the present invention may be selected from the diluent, binder, disintegrants, flow promoters/antiadherents, flavors and sweetening agents.
  • the diluent of the present invention may be selected from water soluble diluents well known in the art such as mannitol, lactose, sucrose, glucose, fructose, sorbitol, xylitol, calcium sulfate, calcium carbonate, microcrystalline cellulose and maltodextrin.
  • Preferred diluents are mannitol and sorbitol as they form the low density matrix which disintegrates rapidly within the mouth.
  • the diluent is usually present in an amount of upto 90 weight percent, preferably upto 70 weight percent.
  • Binders may include starch; gelatin; sugars such as molasses, lactose, glucose, dextrose and sucrose; natural and synthetic gums such as acacia, sodium alginate, carboxymethyl cellulose, methylcellulose, polyvinyl pyrrolidone and veegum.
  • Disintegrating agents may be selected from celluloses such as croscarmellose sodium, starches such as potato starch, clay such as bentonite, gums such as sodium alginate, polymers such as hydroxypropyl methyl cellulose and effervescent agents such as citric acid and sodium bicarbonate.
  • Flow promoters / anti-adherents may be selected from magnesium stearate, talc, aerosil and sodium stearyl fumarate.
  • Excipients such as coloring agents, flavoring agents, artificial sweeteners; having acceptable food and drug approval and which are compatible with the cementing agent and active, can be included.
  • Active substances may be selected from the pharmaceuticals but may also include vitamins, minerals or dietary supplements.
  • Pharmaceuticals may include antacids such as omeprazole, non-steroidal anti-inflammatory drugs such as rofecoxib and nimesulide, steroidal anti-inflammatory drugs such as betamethasone, anti-psychotic drugs such as olanzapine, hypnotic drugs such as alprazolam, antiepileptic drugs such as sodium valproate, antiparkinsonism drugs such as levodopa, hormone drugs such as progestin, analgesic drugs such as aspirin, serotonin 5HT receptor antagonists such as ondansetron, diuretic drugs as sulphamethoxazole, coronary vasdilators such as nitroglycerin, H2 receptor antagonists such as ranitidine hydrochloride, antiarrhythmic drugs such as pindolol, cardiotonic drugs such as digitoxin, calcium antagonists such as diltia
  • bronchodilators such as salbutamol, ⁇ -adrenergic receptor blockers such as
  • osteoporosis treating drugs such as sodium alderonate, antifungal drugs such as fluconazole, antivirals drugs such as lamivudine, drugs for erectile dysfunction such as sildenafil and antidepressant such as sertraline.
  • the active ingredients are not particularly limited to the above examples, and not only to pharmaceutical drugs but also various other substances such as diagnostic drugs, food and dental plaque disclosing agent can be applied to the preparation of the present invention.
  • Active substances can be coated, if desired. Active substances may have a taste mask coating.
  • the inventive process of the present invention comprises uniform blending of the pharmaceutically active ingredient with the cementing agent, and the optional excipients such as diluent, binder, disintegrant, sweetener, flavoring agent and flow enhancer.
  • the powder blend is sieved through fine mesh to obtain fine powder and volumetrically filled into the mold/final pack. Filling may be done manually, semi-automatically or automatically.
  • the powder blend can be pressed slightly after filling inside the mold/pack either by manual or automatic tapping or rollers.
  • the powder blend can be granulated before filling, if desired. Filled final packs are either sealed first and heated or heated as such.
  • Heating may be done at about 25 9 C to about 80 9 C, but preferably at about 50 9 C to about 60 9 C.
  • the mold to be used is not particularly limited, and those made of metals or resin films may be used.
  • a preferred mold is a resin film sheet having a number of hollows, which is used for the enclosure of tablets by Press Through Pack (blister packaging). After filling in the resin film sheet, a cover sheet for use in usual Press Through Pack (blister packaging) is adhered to the resulting resin film sheet, thereby, easily obtaining packages of the solid preparation of the present invention.
  • the material of the sheet has no particular limitation, and may be selected from polypropylene, polyvinyl chloride, polyvinylidene chloride and the like.
  • the shape of the mold is not particularly limited, the hollow of the mold may preferably have a globular shape. After heating, the molds / packs are allowed to cool to ambient temperature.
  • the dosage forms prepared by the present inventive process disintegrates when taken into the mouth within about 15 seconds, preferably within about 10 seconds and especially within about 5 seconds because of its highly porous nature and there is no after taste or grittiness.
  • Rofecoxib, aspartame, orange flavour, croscarmellose sodium, PEG 8000 and sorbitol are sifted through (60 BSS) sieve and mixed.
  • the powder is dosed by weight / volume into preformed blisters.
  • Blisters are sealed using an appropriate covering sheet such as aluminium foil or aluminium foil paper laminates. After sealing, blister strips are heated at about 60 9 C for approx. 10 minutes and allowed to cool to room temperature.
  • Sealed blister strips are heated at about 60 9 C for approx. 15 minutes and allowed to cool to room temperature.

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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 un procédé pour préparer une forme posologique rapidement soluble telle qu'un comprimé qui fond rapidement dans la bouche. Le procédé de l'invention est particulièrement adapté aux médicaments sensibles à l'humidité, faiblement compressibles et amers, munis d'un enrobage masquant le goût.
EP01270300A 2000-12-15 2001-12-07 Procede de preparation d'une forme posologique rapidement soluble Withdrawn EP1343481A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
INDE117000 2000-12-15
IN1170DE2000 IN192750B (fr) 2000-12-15 2000-12-15
PCT/IB2001/002354 WO2002047607A2 (fr) 2000-12-15 2001-12-07 Procede de preparation d'une forme posologique rapidement soluble

Publications (2)

Publication Number Publication Date
EP1343481A2 true EP1343481A2 (fr) 2003-09-17
EP1343481A4 EP1343481A4 (fr) 2004-03-17

Family

ID=11097139

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01270300A Withdrawn EP1343481A4 (fr) 2000-12-15 2001-12-07 Procede de preparation d'une forme posologique rapidement soluble

Country Status (4)

Country Link
EP (1) EP1343481A4 (fr)
AU (1) AU2002220968A1 (fr)
IN (1) IN192750B (fr)
WO (1) WO2002047607A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11179331B1 (en) 2020-04-21 2021-11-23 Cure Pharmaceutcai Holding Corp Oral soluble film containing sildenafil citrate

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DE10232113A1 (de) 2002-07-16 2004-01-29 Bayer Ag Vardenafil Hydrochlorid Trihydrat enthaltende Arzneimittel
KR100503949B1 (ko) * 2003-04-28 2005-07-26 주식회사유한양행 염산 온단세트론의 쓴맛을 효과적으로 은폐한 경구용 구강속붕해정 조성물
FR2858556B1 (fr) * 2003-08-06 2006-03-10 Galenix Innovations Composition pharmaceutique solide dispersible et/ou orodispersible non pelliculee contenant au moins le principe actif metformine, et procede de preparation
EP1510208A1 (fr) 2003-08-22 2005-03-02 Fournier Laboratories Ireland Limited Compositions pharmaceutiques comprenant une combinaison de metformine et de statine
WO2005062722A2 (fr) * 2003-11-21 2005-07-14 Sun Pharmaceutical Industries Limited Composition pharmaceutique orale
US20090060983A1 (en) * 2007-08-30 2009-03-05 Bunick Frank J Method And Composition For Making An Orally Disintegrating Dosage Form
EP2044929A1 (fr) * 2007-10-04 2009-04-08 Laboratorios del Dr. Esteve S.A. Comprimés oraux à désintégration rapide
KR101560176B1 (ko) 2007-10-31 2015-10-14 맥네일-피피씨, 인코포레이티드 구강내 붕해성 투여 형태
DE102008047910A1 (de) 2008-09-19 2010-03-25 Molkerei Meggle Wasserburg Gmbh & Co. Kg Tablettierhilfsstoff auf Laktose- und Cellulosebasis
US9610224B2 (en) 2009-09-24 2017-04-04 Johnson & Johnson Consumer Inc. Manufacture of tablet in a die utilizing powder blend containing water-containing material
US8858210B2 (en) 2009-09-24 2014-10-14 Mcneil-Ppc, Inc. Manufacture of variable density dosage forms utilizing radiofrequency energy
US8581001B2 (en) 2010-04-16 2013-11-12 Codman & Shurtleff Metformin-cysteine prodrug
US9119793B1 (en) 2011-06-28 2015-09-01 Medicis Pharmaceutical Corporation Gastroretentive dosage forms for doxycycline
CN102258497B (zh) * 2011-08-18 2013-01-09 海南良方医药有限公司 一种拉米夫定片剂组合物及其制备方法
US9511028B2 (en) 2012-05-01 2016-12-06 Johnson & Johnson Consumer Inc. Orally disintegrating tablet
US9445971B2 (en) 2012-05-01 2016-09-20 Johnson & Johnson Consumer Inc. Method of manufacturing solid dosage form
US9233491B2 (en) 2012-05-01 2016-01-12 Johnson & Johnson Consumer Inc. Machine for production of solid dosage forms
US10842802B2 (en) 2013-03-15 2020-11-24 Medicis Pharmaceutical Corporation Controlled release pharmaceutical dosage forms
CN103432091A (zh) * 2013-09-13 2013-12-11 钟术光 一种性能改善的片剂及其制备方法
ES2750323T3 (es) 2014-01-10 2020-03-25 Johnson & Johnson Consumer Inc Método para la fabricación de un comprimido mediante radiofrecuencia y partículas recubiertas con pérdida
US10493026B2 (en) 2017-03-20 2019-12-03 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles
HUE064287T2 (hu) 2019-02-22 2024-02-28 Catalent Uk Swindon Zydis Ltd Hatóanyagrészecske-bevonóanyag agglomerálódásának minimalizálása tárolás során, gyógyszerészeti termékek szétesési idejének stabilizálására
US11166919B2 (en) 2019-02-22 2021-11-09 Catalent U.K. Swindon Zydis Limited Minimizing agglomeration, aeration, and preserving the coating of pharmaceutical compositions comprising ibuprofen
CA3178769A1 (fr) 2020-05-18 2021-11-25 Jonas Savmarker Nouvelle composition pharmaceutique pour une administration de medicament
AR127780A1 (es) 2021-11-25 2024-02-28 Orexo Ab Nueva composición farmacéutica que comprende adrenalina

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EP0166440A2 (fr) * 1984-06-28 1986-01-02 THE PROCTER & GAMBLE COMPANY Compostion antiacide
GB2293099A (en) * 1994-09-15 1996-03-20 Mailway Packaging Group Ltd Drug formulation
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EP0166440A2 (fr) * 1984-06-28 1986-01-02 THE PROCTER & GAMBLE COMPANY Compostion antiacide
GB2293099A (en) * 1994-09-15 1996-03-20 Mailway Packaging Group Ltd Drug formulation
WO1999043306A1 (fr) * 1998-02-26 1999-09-02 Banyu Pharmaceutical Co., Ltd. Composition a desintegration orale et son procede de fabrication
EP0960621A2 (fr) * 1998-05-15 1999-12-01 Pfizer Inc. Compositions pharmaceutiques comprenant du sildenafil

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11179331B1 (en) 2020-04-21 2021-11-23 Cure Pharmaceutcai Holding Corp Oral soluble film containing sildenafil citrate

Also Published As

Publication number Publication date
WO2002047607A3 (fr) 2003-03-20
IN192750B (fr) 2004-05-15
WO2002047607A2 (fr) 2002-06-20
EP1343481A4 (fr) 2004-03-17
AU2002220968A1 (en) 2002-06-24

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