EP2262475A1 - Comprimé à mâcher et procédé de formulation - Google Patents

Comprimé à mâcher et procédé de formulation

Info

Publication number
EP2262475A1
EP2262475A1 EP07862797A EP07862797A EP2262475A1 EP 2262475 A1 EP2262475 A1 EP 2262475A1 EP 07862797 A EP07862797 A EP 07862797A EP 07862797 A EP07862797 A EP 07862797A EP 2262475 A1 EP2262475 A1 EP 2262475A1
Authority
EP
European Patent Office
Prior art keywords
agents
active ingredient
tableting
process according
tablet
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Withdrawn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
EP07862797A
Other languages
German (de)
English (en)
Inventor
Ajmal Ali Khan
Eddie Brunson
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.)
Bayer Consumer Care Holdings LLC
Original Assignee
Schering Plough Healthcare Products 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.)
Filing date
Publication date
Application filed by Schering Plough Healthcare Products Inc filed Critical Schering Plough Healthcare Products Inc
Publication of EP2262475A1 publication Critical patent/EP2262475A1/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Withdrawn legal-status Critical Current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
    • 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
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
    • 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

Definitions

  • Chewable tablet formulations particularly those containing pharmaceutically active agents, present issues of organoleptic characteristics of odor, taste, appearance and mouth feel.
  • the formula ingredients and manufacturing process both play a role in obtaining the desired organoleptic properties.
  • Manufacturing of tablet products is generally done using either a wet granulation process or direct compression, see, e.g., Pharmaceutical Dosage
  • the wet granulation process typically involves wet massing of the formula ingredients using a liquid to form aggregates. The process requires a drying step to remove the liquid, following which the dried aggregates are reduced to an appropriate size by milling. Over-wetting of granules in the wet granulation process can produce harder granules. Tablets made from such granulations often have a gritty mouth-feel when chewed, see, e.g., Pharmaceutical Dosage Forms: Tablets Volume 1 , Marcel Dekker Inc. Second Edition 1989, editors Lieberman, Lachman and Schwarz, Page 396. This grittiness can be avoided by using a direct compression manufacturing process which eliminates the wet massing and subsequent drying steps.
  • micronized and submicron forms of therapeutically and/or physiologically active substances are being incorporated into tablet formulations to take advantage of the enhanced absorption characteristics of these forms.
  • the use of a micronized or submicron form makes it difficult to disperse the drug uniformly in the powder blend using a conventional direct compression process.
  • a method of preparing a chewable tablet that comprises a low concentration of micronized or submicron active ingredient forms but having a uniform active ingredient dispersion and beneficial organoleptic qualities would be desirable.
  • the present invention provides a process for preparing a chewable tablet comprising a micronized form or submicron form of an active ingredient, the method comprising the steps of combining the active ingredient with tablet excipients by geometric dilution to form a final mixture and applying direct compression to at least a portion of the final mixture to form at least one tablet.
  • at least one of the active ingredients present in the composition is an antihistamine.
  • the active ingredient is loratadine or desloratadine.
  • the invention also provides a process for preparing a chewable tablet from a composition comprising an amount of at least one active ingredient in micronized form or submicron form and a plurality of tableting excipients, wherein the chewable tablet exhibits acceptable content uniformity of active ingredient, the process comprising: a) dividing a first tableting excipient into a plurality of portions; b) combining a percentage of the amount of the active ingredient with a first portion of the first tableting excipient in the absence of additional tableting excipients to form a primary premixture; c) combining one or more additional tableting excipients from the plurality of tableting excipients into one or more remaining portions of the first tableting ingredient not containing the active ingredient to form one or more secondary premixtures; d) adding said one or more secondary premixtures to the primary premixture to form a main batch; and e) applying direct compression to at least a portion of the main batch to form at least one tablet.
  • the percentage of the amount of the active ingredient added to said first portion of said first tableting excipient is typically greater than 50%, and in additional embodiments can be greater than 75%, greater than 80%, greater than 90%, up to 100%. In the practice of the process wherein less than the entire amount of active ingredient is added to the first portion, the remainder of the amount of active ingredient is added to one or more of the secondary premixtures prior to formation of the main batch.
  • the so called first tableting excipient is typically, but not always, the largest component of the composition by weight percentage of the total composition.
  • the first tableting excipient is a sweetener, such as mannitol.
  • additional tableting excipients can be used in the compositions of the invention.
  • the secondary premixtures can be separately added to the primary premixture or two or more of said secondary premixtures can be combined prior to being added to the primary premixture.
  • one or more of the tableting excipients can be deagglomerated during the process, such as by passing through a mill or screen.
  • the first tableting excipient can be deagglomerated prior to step (a) or step (b).
  • one or more of the primary premixture and the one or more secondary premixtures can be deagglomerated prior to step (d).
  • the process of the invention may further comprise the step of combining one or more tableting excipients with at least one portion of said main batch to form a tertiary premixture and then adding that tertiary premixture to the main batch.
  • the tertiary premixture may be deagglomerated, such as by passing through a mill or screen, prior to its being added to said main batch.
  • the invention further provides a process for preparing a chewable tablet comprising an antihistamine in micronized form or submicron form and tableting excipients, the method comprising the steps of combining antihistamine with tableting excipients by geometric dilution to form a final mixture and applying direct compression on the final mixture to produce tablet shapes, wherein any two of said chewable tablets exhibits bioequivalence to one non-chewable tablet comprising an equal or similar amount of antihistamine.
  • the antihistamine is loratadine or desloratadine.
  • the invention also provides a chewable tablet comprising an antihistamine in micronized form or submicron form and tableting excipients, wherein the chewable tablet exhibits acceptable organoleptic qualities, antihistamine content uniformity, rapid dissolution, a substantial absence of binding in the die cavities and a substantial absence of sticking to punch faces under compression.
  • two of said chewable tablets exhibit bioequivalence to one nonchewable tablet comprising an equal or similar amount of antihistamine.
  • the antihistamine is present in an amount up to about 2.0 weight % per tablet.
  • the antihistamine is loratadine or desloratadine.
  • Figure 1 provides an example of an embodiment of a manufacturing process according to the invention.
  • active ingredient refers any substance having a measurable activity of therapeutic, cosmetic or nutraceutical nature, towards a human or animal to which the active ingredient is administered.
  • active ingredients can be utilized in forming the products of this invention, including, for example, pharmaceuticals, dietary supplements, animal feeds, or biocidal agents.
  • the processes according to the present invention are particularly useful for preparation of tablets comprising low amounts of micronized or submicron active ingredients, such as formulations containing up to about 5% by weight of the tablet, alternatively containing up to about 4%, about 3%, about 2%, or about 1% by weight of the tablet.
  • adrenergics include, for example, adrenergics; adrenocortical steroids; adrenocortical suppressants; aldosterone antagonists; amino acids; anabolics; analeptics; analgesics; anesthetics; anorectics; antiacne agents; antiadrenergics; antiallergics; antiamebics; antianemics; antianginals; antiarthritics; antiasthmatics; antiatherosclerotics; antibacterials; anticholinergics; anticoagulants; anticonvulsants; antidepressants; antidiabetics; antidiarrheals; antidiuretics; antiemetics; antiepileptics; antifibrinolytics; antifungals; antihemorrhagics; antihistamines; antihyperlipidemics; antihypertensives; antihypotensives
  • Examples of analgesics include codeine, diamorphine, dihydromorphine, ergotamine, fentanyl and morphine; examples of antiallergics include cromoglycic acid and nedocromil; examples of antibiotics include cephalosporins, fusafungin, neomycin, penicillins, pentamidine, streptomycin, sulfonamides and tetracyclines; examples of anticholinergics include atropine, atropine methonitrate, ipratropium bromide, oxitropium bromide and trospium chloride; examples of antihistamines include Hi or H2 antagonists or other types of histamine release inhibitors, the Hi antagonists can be sedating or non-sedating, such as diphenhydramine, chlorpheniramine, tripelennamine, promethazine, clemastine, doxylamine, astemizole, terfenadine, loratadine and deslorata
  • the active ingredients mentioned by way of example can be employed as free bases or acids or as pharmaceutically acceptable salts.
  • Counterions which can be employed are, for example, physiologically tolerable alkaline earth metals or alkali metals or amines, as well as, for example, acetate, benzenesulfonate, benzoate, hydrogen carbonate, hydrogen tartrate, bromide, chloride, iodide, carbonate, citrate, fumarate, malate, maleate, gluconate, lactate, pamoate and sulfate.
  • Esters can also be employed, for example including but not limited to acetate, acetonide, propionate, dipropionate, valerate.
  • micronized as used herein has its customary meaning, and generally refers to materials having a particle size ranging from about 1 ⁇ m up to about 30 ⁇ m, more preferably up to about 20 ⁇ m and more preferably up to about 5 ⁇ m.
  • submicron as used herein has its customary meaning, and generally refers to materials having a particle size up to about 1 ⁇ m.
  • Methods of making micronized and submicron forms of active ingredients are well known in the art and include, for example, attrition mills, fluid energy mills and micronizers. Methods are discussed, for example, in Advanced Pharmaceutical Solids, Jens T. Cartensen. p 330 (Marcel Dekker Inc. 2001) and Rasenack, M. and Muller, B.W., "Micron-Size Drug particles: Common and Novel Micronization Techniques", Pharmaceutical Development and Technology, VoI 9, No. 1 , pp. 1-13 (2004).
  • bioequivalence has its customary meaning referring to the ratio of the least square mean of C max and AUC of a test compound to the least square mean of C max and AUC of the reference compound falling within 0.8 to 1.25 at the 90% confidence intervals.
  • additional components generally referred to herein as tableting excipients, can be included which have desirable functions and characteristics that enable the formation of chewable tablets comprising the micronized active ingredient.
  • tableting excipients include, but are not limited to, agents that impart desired attributes of chewablity and mouth feel, flow aids, disintegrants, lubricants, mold release agents, sweeteners and flavorants, colorants, stabilizers, adjuvants, corrosion inhibitors, dyes, surfactants, synergists, effervescents, diluents, builders, chelating agents, buffers, and the like.
  • agents that impart desired attributes of chewablity and mouth feel include, but are not limited to, agents that impart desired attributes of chewablity and mouth feel, flow aids, disintegrants, lubricants, mold release agents, sweeteners and flavorants, colorants, stabilizers, adjuvants, corrosion inhibitors, dyes, surfactants, synergists, effervescents, diluents, builders, chelating agents, buffers, and the like.
  • binders are those substances known to one of ordinary skill in the art as natural or synthetic binders, e.g., hydroxyalkyl cellulose, such as hydroxy methyl cellulose and hydroxy ethyl cellulose; methyl cellulose; plant gums including traganth gum, gum arabicum, carayagum, guar gum, xanthan gum, and irish moss; polyvinyl pyrrolidone, polynicyl alcohol, polyvinyl acetate, gelatin, starch, carboxy methyl starch; polyurethanes, synthetic polyelectrolytes, polyalkylene glycols, inorganic thickening agents, including various forms of silicon oxide and silicon dioxide, such as amorphous, hydrogels, pyrogenic, sublimated or suspended particles, and silicates.
  • hydroxyalkyl cellulose such as hydroxy methyl cellulose and hydroxy ethyl cellulose
  • methyl cellulose methyl cellulose
  • plant gums including traganth gum
  • Conventional adjuvants include, for example, carrier substances, such as the sugars lactose, saccharose, mannitol, or sorbitol, cellulose preparations and/or calcium phosphate, such as tricalcium phosphate or calcium hydrogen phosphate, the starches of corn, wheat, rice, or potato, methyl cellulose, hydroxy methyl cellulose, sodium carboxy-methyl cellulose and/or polyvinyl pyrrolidone.
  • Additional adjuvants are in particular flow aids and lubricants, include such substances as silica, talcum, stearic acid or salts thereof such as the magnesium, calcium, sodium, and potassium stearates, polyethylene glycol and its derivatives, hard paraffin and combinations thereof.
  • Wetting agents are materials that accelerate the solubilization and/or the dissolution of the active substance(s) and the other excipients contained in the micronized powder.
  • Diluents are materials added to the powder containing the active substance(s) until a predetermined total volume containing a selected amount of the active substance(s) is obtained.
  • Sweeteners may be those typically used in consumable products and include, but are not limited to, such substances as aspartame, dextrates, dextrose, fructose, mannitol, sodium or calcium saccharinate, sorbitol, sucralose, sucrose, and mixtures thereof.
  • the flavor additive may be any flavors of synthetic, semi-synthetic or natural origin that are typically used in consumable products and are well known to those of ordinary skill in the art. Representative examples include, but are not limited to, mint, peppermint, lemon, grape, banana, strawberry, raspberry, orange, vanilla, caramel, and mixtures thereof. Also, colorants can be added to the mixtures, including all
  • FD&C and D&C colorants approved for use in foods, drugs, cosmetics and/or medical devices.
  • a list of colorants approved for use in foods, drugs, cosmetics and/or medical devices in the United States is provided at 21 C. F. R. Parts 73 and 74, which list is periodically updated. It is understood that similar lists in various jurisdictions, and updated versions thereof, will guide those of ordinary skilled in the art towards appropriate colorants for use in preparing compositions and tablets according to the invention.
  • the colorant may be FD&C blue #2 dye aluminum lake, D&C red #27 dye aluminum lake, FD&C blue #1 dye aluminum lake, FD&C green #3 dye aluminum lake, D&C green # 5 dye aluminum lake, FD&C red # 3 dye aluminum lake, D&C red # 6 dye aluminum lake, D&C red # 7 dye aluminum lake, D&C red # 21 dye aluminum lake, D&C red # 22 dye aluminum lake, D&C red # 30 dye aluminum lake, D&C red # 33 dye aluminum lake, D&C red # 36 dye aluminum lake, D&C red # 40 dye aluminum lake, FD&C red # 40 dye aluminum lake, FD&C yellow # 5 aluminum lake, FD&C yellow #6 dye aluminum lake, D&C yellow # 10 dye aluminum lake, synthetic iron oxide pigments and combinations thereof.
  • the invention will be further described by means of the following examples, which are not intended, and should not be interpreted, to limit the invention which is more fully defined by the claims which follow thereafter.
  • Chewable tablets containing loratadine were manufactured using a direct compression process according to the subject invention to produce tablets with sufficient flow and compressibility suitable for high speed manufacturing while assuring uniform loratadine content uniformity, rapid dissolution, absence of binding in the die cavities and absence of sticking to punch faces under compression.
  • the loratadine used was micronized material added at a relatively low concentration resulting in a final content of 5 mg loratadine per tablet.
  • Chewable tablets were prepared according to the process described herein containing the following materials per tablet.
  • the batch size was 2.1 million tablets.
  • Figure 1 provides the flow diagram of the manufacturing process used.
  • Spray dried mannitol was de-agglomerated before use by milling and then added in four separate portions to the batch.
  • Loratadine was dispersed in a pre-mixture with a portion of the mannitol and de-agglomerated by passing through a screen.
  • a second pre- mixture was prepared consisting of the FD&C blue #2 aluminum lake, D&C red #27 aluminum lake, citric acid, aspartame and colloidal silicon dioxide.
  • the pre-mixture was then de- agglomerated by passing through a mill.
  • Sodium starch glycolate, microcrystalline cellulose and grape flavor were then passed through a screen individually before addition to the batch.
  • the lubricants magnesium stearate and stearic acid were then mixed with portions of the material from the main batch and passed through a screen before adding to the batch. After addition of the lubricants, the powder was mixed and then compressed into tablets.
  • the process steps for preparation of the powder mixture are done sequentially as a batch over a period of about 8 hours.
  • the currently verified hold time for prepared powder mixture prior to compression into tablets is 14 days.
  • Content uniformity testing on the compressed tablets provides an assessment of how uniformly the micronized or submicron active ingredient is dispersed in the powder mixture.
  • Content uniformity of loratadine in tablets prepared according to the invention was determined according to the following procedure: the tablet was accurately weighed and placed into a 50 mL volumetric flask and 20 ml_ of a diluent was then added. The diluent was prepared by adding 400 mL of 0.05N hydrochloric acid and 80 ml_ of 0.6M dibasic potassium phosphate into a 1.0 L volumetric flask, diluted to volume with methanol:acetonitrile (1 :1 ) and mixed.
  • the flasks with the tablets and diluent were shaken on a wrist action shaker for 40 minutes.
  • the flasks were diluted to volume with the diluent and mixed.
  • a portion of the solution was filtered through through a 0.45 micron Whatman GD/X hrdrophobic PTFE membrane filter. The first three mL were discarded and then an aliquot was collected in an HPLC vial for HPLC analysis.
  • Acceptance criteria used for content uniformity is the current USP ⁇ 905> for content uniformity of tablets which consists of two stages of testing. Stage 1 testing is conducted on 10 tablets to determine percent label strength, with the goal of determining no tablet outside 85.0 % to 115.0 % of label strength, with relative standard deviation (RSD) less than or equal to 6.0
  • stage 2 testing would be conducted on 30 tablets with the goal of determining percent label strength within 75.0 % to 125 % of label strength, RSD less than or equal to 7.8%.
  • a randomized, open label, single dose, two-way crossover study was performed to compare the bioequivalence of 2 x 5 mg loratadine chewable tablets prepared according to the invention against one loratadine 10 mg swallow tablet in healthy adult subjects.
  • a total of 48 subjects were enrolled and all 48 subjects were analyzed. Subjects were screened for eligibility within
  • AUC ⁇ the area under the concentration-time curve from time zero to last measurable concentration
  • AUC the area under the concentration-time curve from time zero to infinity

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

Abstract

L'invention concerne des procédés de préparation d'un comprimé à mâcher qui comporte une forme micronisée d'un ingrédient actif, le procédé comportant les étapes consistant à combiner l'ingrédient actif avec des excipients de comprimé par dilution géométrique pour former un mélange final et à appliquer une compression directe à au moins une partie du mélange final pour former au moins un comprimé.
EP07862797A 2008-04-01 2008-04-01 Comprimé à mâcher et procédé de formulation Withdrawn EP2262475A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2007/025388 WO2009123580A1 (fr) 2008-04-01 2008-04-01 Comprimé à mâcher et procédé de formulation

Publications (1)

Publication Number Publication Date
EP2262475A1 true EP2262475A1 (fr) 2010-12-22

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Family Applications (1)

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EP07862797A Withdrawn EP2262475A1 (fr) 2008-04-01 2008-04-01 Comprimé à mâcher et procédé de formulation

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EP (1) EP2262475A1 (fr)
WO (1) WO2009123580A1 (fr)

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Publication number Priority date Publication date Assignee Title
ITMI20110713A1 (it) 2011-04-29 2012-10-30 Bracco Imaging Spa Processo per la preparazione di un derivato solfatato di3,5-diiodo-o-[3-iodofenil]-l-tirosina
WO2015044394A1 (fr) * 2013-09-30 2015-04-02 Sandoz Ag Composition pharmaceutique comprenant une faible dose de principe actif pharmaceutique et sa préparation
US12274703B2 (en) 2017-12-21 2025-04-15 Gliapharm Sa Compositions and methods of treatment for neurological disorders comprising a dementia
US12310967B2 (en) 2017-12-21 2025-05-27 Gliapharm Sa Compositions and methods of treatment for neurological disorders comprising motor neuron diseases
WO2020132378A2 (fr) 2018-12-22 2020-06-25 Gliapharm Sa Compositions et méthodes de traitement de troubles neurologiques comprenant la dépression
CN118904458B (zh) * 2024-10-10 2025-03-07 浙江子久文化股份有限公司 一种含有黄茶粉的护肝型咀嚼片及其制备方法

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US4517179A (en) * 1983-04-29 1985-05-14 Pennwalt Corporation Rapid dissolving, uniform drug compositions and their preparation
US5132114A (en) * 1985-05-01 1992-07-21 University Of Utah Research Foundation Compositions and methods of manufacture of compressed powder medicaments
US5895664A (en) * 1993-09-10 1999-04-20 Fuisz Technologies Ltd. Process for forming quickly dispersing comestible unit and product therefrom
US6489346B1 (en) * 1996-01-04 2002-12-03 The Curators Of The University Of Missouri Substituted benzimidazole dosage forms and method of using same
US7101569B2 (en) * 2001-08-14 2006-09-05 Franz G Andrew Methods of administering levothyroxine pharmaceutical compositions
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