WO2023128900A1 - Compositions pharmaceutiques comprenant de la pimavansérine comme principe actif et excipients appropriés - Google Patents

Compositions pharmaceutiques comprenant de la pimavansérine comme principe actif et excipients appropriés Download PDF

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Publication number
WO2023128900A1
WO2023128900A1 PCT/TR2021/051621 TR2021051621W WO2023128900A1 WO 2023128900 A1 WO2023128900 A1 WO 2023128900A1 TR 2021051621 W TR2021051621 W TR 2021051621W WO 2023128900 A1 WO2023128900 A1 WO 2023128900A1
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WO
WIPO (PCT)
Prior art keywords
pimavanserin
pharmaceutical composition
capsule
pharmaceutical
composition according
Prior art date
Application number
PCT/TR2021/051621
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English (en)
Inventor
Abdulhaluk SANCAK
Ayse Figen ONUK GOREN
Trinadh POTUMUDI
Gizem ALKAN
Asiye Sezgin
Hakan GURPINAR
Koray YILMAZ
Original Assignee
Pharmactive Ilac Sanayi Ve Ticaret A.S.
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 Pharmactive Ilac Sanayi Ve Ticaret A.S. filed Critical Pharmactive Ilac Sanayi Ve Ticaret A.S.
Priority to PCT/TR2021/051621 priority Critical patent/WO2023128900A1/fr
Publication of WO2023128900A1 publication Critical patent/WO2023128900A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs

Definitions

  • the present invention relates to the preparation of pharmaceutical compositions comprising pimavanserin is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, having specific polymorph with other relevant excipients in formulation.
  • Pimavanserin has active moiety of the tartrate salt with the chemical name of urea, N-[(4- fluorophenyl)methyl]-N-(l-methyl-4-piperidinyl)-N’- ⁇ [4-(2-methylpropoxy)phenyl] methyl ⁇ , (2R,3R)-2,3-dihydroxybutanedioate. It has molecular weight of 427.55 g/mol, white or off- white powder.
  • Pimavanserin has been used for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
  • Parkinson's disease is a progressive nervous system disorder that affects movement. It is a condition in which parts of the brain become progressively damaged over many years. Parkinson's disease is a brain disorder that leads to shaking, stiffness, and difficulty with walking, balance, and coordination.
  • parkinson's symptoms may include: involuntary shaking of particular parts of the body, slow movement, stiff and inflexible muscles, impaired posture and balance, loss of automatic movements, speech and writing changes.
  • the pimavanserin compound can be in amorphous form, in polymorphic forms, or both.
  • Pimavanserin tartrate can be obtained in many polymorphic forms as described in W02006/037043.
  • Polymorphic Form C has been found to be a thermostabile form of pimavanserin.
  • pimavanserin tartrate exhibits a X-ray powder diffraction pattern comprising peaks having d-values in angstroms of about 12.0, about 10.7, about 5.86, about 4.84, about 4.70, about 4.57, and about 3.77 , it is called form C of pimavanserin tartrate.
  • there are different polymorphic forms of pimavanserin such as Form I, form II, form III, form IV, form B, form C, form D, form E, form F and also form A.
  • Originator of pimavanserin product is Acadia Pharmaceuticals. Acadia has many granted patents and patent applications about form C polymorph of pimavanserin.
  • polymorphism has crucial effect to property of pharmaceutical drugs.
  • Polymorphic forms of a drug substance can effect many chemical and physical properties, such as melting point, chemical reactivity, apparent solubility, dissolution rate, optical and mechanical properties, vapor pressure, and density. These kind of properties can have a potential effect on the ability to manufacturing the drug substance and also the drug product.
  • Polymorphism effects on drug product stability, dissolution, and bioavailability. After all, polymorphism can affect the quality, safety, and efficacy of the drug product.
  • W02007/133802 relates to tablet composition comprising pimavanserin tartarat prepared by wet granulation.
  • WO2017/015272 relates to capsule composition comprising pimavanserin tartarat form C.
  • WO20 19046167 relates to capsule composition comprising pimavanserin prepared by wet granulation.
  • US2020009122 relates to capsule composition comprising pimavanserin tartarat prepared by wet granulation. Capsule sizes is 3 or 4.
  • the present invention provides a pharmaceutical composition comprising pimavanserin or pharmaceutically acceptable salts or esters thereof, for the the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, wherein process including dry granulation method.
  • a pharmaceutical composition in the form of capsule comprising: a) pimavanserin or a salt thereof in polymorphic form A, b) at least one filler, c) at least one lubricant, wherein the pharmaceutical product is prepared by dry granulation.
  • Figure 3 Comparative Dissolution Profiles of Nuplazid 34mg Capsule and Pimavanserin 34mg Capsule (Test Product) pH 1.2 with 0, 1 HCL + 0,1% CTAB .
  • Figure 4 Comparative Dissolution Profiles of Nuplazid 34mg Capsule and Pimavanserin 34mg Capsule (Test Product) in acetat buffer pH 4.5 with % 0.1 CTAB
  • Figure 5 Comparative Dissolution Profiles of Nuplazid 34mg Capsule and Pimavanserin 34mg Capsule (Test Product) in phosphate buffer pH 6.8 with 0,1% CTAB.
  • Figure 7 X-ray powder diffraction pattern of Form C of pimavanserin tartrate
  • the present invention relates to preperation of pharmaceutical compositions comprising pimavanserin in the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
  • the present invention provides a pharmaceutical composition comprising pimavanserin or pharmaceutically acceptable salts or esters thereof, for the the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, wherein process including dry granulation method.
  • Dosage forms of capsule and tablet forms are used commonly for oral administration way.
  • Tablet form has many advantages like cost-effective, lighter and compact, easiest and cheapest to package, can be masked by coating technique and greatest chemical and microbial stability over all oral dosage forms.
  • Capsule form has many advantages like masking the odor and taste of unpleasant medicines, being simply administered, fewer excipients are required than tablets, easy to swallow with water, easy to handle and take and digesting easily and quickly in the gastrointestinal tract.
  • a pharmaceutical composition may comprise one or more pharmaceutically acceptable excipient(s).
  • Pharmaceutically acceptable excipients examples can be filler, disintegrant, binder, surfactant, lubricant, solvent, antiadherent, flavor, glidant, preservative, sweetener, suspending/viscosity agent, diluent, colorant and the mixtures thereof.
  • Ideal pharmaceutical excipient profile should have suitable physical and chemical properties with active ingredient and also other raw materials. These properties can be stable and reproducible, no unwanted interaction with active ingredient, inert property, desired functionality and cost effective.
  • the present invention relates to the preparation of pharmaceutical compositions comprising pimavanserin or pharmaceutically acceptable salts or esters thereof, and one or more pharmaceutically acceptable carriers or excipients.
  • the present invention relates to the preparation of pharmaceutical compositions comprising pimavanserin or pharmaceutically acceptable salts or esters thereof, and one or more pharmaceutically acceptable carriers or excipients, comprising a filler and a lubricant.
  • the present invention relates to the preparation of pharmaceutical compositions comprising pimavanserin or pharmaceutically acceptable salts or esters thereof, and one or more pharmaceutically acceptable carriers or excipients, comprising a filler and a lubricant, wherein process including dry granulation method.
  • the present invention relates to the preparation of pharmaceutical compositions comprising pimavanserin or pharmaceutically acceptable salts or esters thereof, and one or more pharmaceutically acceptable carriers or excipients, comprising a filler and a lubricant, wherein process including dry granulation method in capsule dosage form.
  • the present invention relates to pimavanserin has the chemical formula, figure 1;
  • pimavanserin can be referred to as (N-(4-fluorophenylmethyl)-N-(l- methylpiperidin-4-yl)-N’-(4-(2-methylpropyloxy) phenylmethyl)carbamide).
  • pimavanserin can be used as a tartrate salt, chemical formula, figure 2;
  • Figure 2 The chemical formula of pimavanserin tartrate Polymorphism is an important characteristic properties for pharmaceutical products especially for solid dosage forms.
  • Polymorphism can effect the formation and properties of medicine both on active ingredients and excipients, fillers, stabilizers, coatings, drying agents, etc. These properties can be related to usage, efficacy and stability of the pharmaceutical products.
  • Dissolution rate and solubility can be influenced by polymorhic forms relevant to the formation of hydrates, solvates, metastable forms and amorphous forms for pharmaceutical products.
  • the present invention relates to pimavanserin tartrate exhibits a X-ray powder diffraction pattern comprising peaks having d-values in angstroms of about 12.0, about 10.7, about 5.86, about 4.84, about 4.70, about 4.57, and about 3.77 , hereinafter referred to as Form C.
  • pimavanserin tartrate of Form C exhibits a X-ray powder diffraction pattern comprising peaks having d-values in angstroms of about 12.0, about 10.7, about 7.4, about 6.9, about 6.6, about 6.2, about 5.86, about 5.53, about 5.28, about 5.16, about 4.84, about 4.70, about 4.57, about 4.38, about 4.09, about 3.94, about 3.77, about 3.71, about 3.49, about 3.46, about 3.25, about 3.08, and about 2.93.
  • pimavanserin tartrate of Form C characterized by having an endotherm with an onset of between 167 and 177 °C as obtained by differential scanning calorimetry (DSC) in accordance with USP ⁇ 891 > .
  • pimavanserin tartrate of Form C may be characterized by powder diffraction (pXRD), see Figure 4 of W02006/037043.
  • crystal form C is the most stable form of all found crystal forms, compared to with other polymorhic forms.
  • Form C has stable properties in chemically. It is easy to formulate for tablets or any other pharmaceutically acceptable dosage form.
  • forms A and B are very suitable to pharmaceutical processing for granulation with water or with solvent-water mixtures.
  • pimavanserin tartrate of Form A exhibits X-ray powder diffraction pattern exhibits the following characteristic peaks expressed in d-values (A): 18.6 (s), 16.7 (vs), 10.2 (s), 8.2 (m), 7.7 (w), 7.4 (w), 6.5 (w), 6.2 (m), 6.1 (vs), 5.86 (w), 5.14 (m), 5.03 (m), 4.78 (m), 4.69 (m), 4.63 (s), 4.49 (s), 4.44 (vs), 4.35 (m), 4.10 (m), 3.96 (s), and 3.66 (m).
  • a pharmaceutical composition in the form of capsule comprising: a) pimavanserin or a salt thereof in polymorphic form A, b) at least one filler, c) at least one lubricant, wherein the pharmaceutical product is prepared by dry granulation.
  • the pharmaceutical composition can be formed using a minimum number of excipients.
  • One of the excipient can be a filler and other excipient can be lubricant except pimavanserin active ingredient.
  • compositions comprising pimavanserin or pharmaceutically acceptable salts or esters thereof, pimavanserin used in polymorphic form A.
  • compositions comprising pimavanserin or pharmaceutically acceptable salts or esters thereof and also an excipient of filler.
  • compositions comprising pimavanserin or pharmaceutically acceptable salts or esters thereof and also an excipient of lubricant.
  • the pharmaceutical composition can be in the form of capsule or tablet.
  • the pharmaceutical composition including pimavanserin tartrate and relevant excipients.
  • this invention includes a dry granulation method with slugging stage for use in preparing capsules, the pharmaceutical composition including pimavanserin or pharmaceutically acceptable salts or esters thereof and relevant excipients.
  • Another embodiment disclosed herein includes includes a method of preparing a pharmaceutical capsule including dry granulating pimavanserin tartrate using slugging phase with a lubricant, and a filler.
  • Microcrystalline Cellulose is one of the most common binding and filling agent used to manufacture solid dose foods and also pharmaceutical industry.
  • MCC microcrystalline cellulose
  • MCC is a good option as an excipient for pressing tablets and also filling empty capsules.
  • One of the main advantages of microcrystalline cellulose is that it helps with flow allowing formulations to move smoothly through capsule filling machinery ensuring consistent capsule weights.
  • Lubricant s main mission is to keep the ingredients in a capsule from sticking together. It also provide a barrier between the ingredients and the machines that are used for manufacturing. The powder improves the consistency and quality of the medication capsules.
  • Pharmaceutical lubricants are the agents added to capsule formulations in specific quantity (generally, 0.25%-5.0%, w/w) to improve the powder processing properties of formulations.
  • Magnesium Stearate is a common lubricant and is called “flow agent” in pharmaceutical industry.
  • a capsule is a dosage form which one or more active pharmaceutical ingredients and excipients are enclosed in a hard or soft soluble shell, generally as gelatin.
  • capsules are classified as types of hard gelatin or soft gelatin. It depends on the nature of the capsule shell. Soft-shelled capsules are used for pharmaceutical products that are dissolved or suspended in oil. On the other side, hard-shelled capsules are used for dry and powdered active ingredients and excipients.
  • target properties of capsule dosage forms is below:
  • the gelatin shell can protect of the drug from light.
  • the shells of capsules have physiologically inert property.
  • Dissolution test values for pharmaceutical compositions are one of the essential parameters for process development and solid dosage manufacturing.
  • excipients that is used in capsule or tablet dosage form are diluent, binder, disintegrants, lubricant, glidant, colouring agent, flavoring agent, sweetening agent and solvent except active ingredient.
  • manufacturing process generally consisting of three stages: a) Sieving and mixing, b) Slugging, Milling and Blending, c) Capsule filling.
  • excipients of filler and lubricant are very critical. These excipients should be in pharmaceutical composition comprising pimavanserin or pharmaceutically acceptable salts or esters thereof with other excipients.
  • the formulations preferably contain active ingredient, filler, lubricant and if needed other excipients.
  • tablets may also be produced.
  • the tablets may vary in shape and be, for example, round, oval, oblong, cylindrical, clover-shaped or any other suitable shape.
  • the present invention provides a pharmaceutical compositions described herein are highly suitable for effective treatment of neuropsychiatric diseases including psychosis, affective disorders, dementia, neuropathic pain and hypertension.
  • the present invention provides a pharmaceutical composition for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
  • crystalline form C is more thermodynamically and chemically stable than form A.
  • pimavanserin in polymorhic form C is known to be more stable compared to other polymorphs, we can obtain a pharmaceutical product similar to the reference product by using Form A.
  • Solubility result of test product (Form A) is well in all medias. There was no precipitation in the solutions and also it dissolved quickly without the need for a hot water bath. According to solubility results of reference product was slower than test product (Form A) and dissolved in a 37 °C hot water bath.
  • compositions of the invention are particularly shows comparatively similar properties in the stability and dissolution property, it is useful as a pharmaceutical product preparation technique.
  • compositions of the invention are particularly suited for the oral administration.
  • the present invention provides pharmaceutical composition comprising pimavanserin and relevant excipients, characterized by i) A simple and exclusive manufacturing process ii) Stable formulation
  • Capsule dosage form is simple, cost-effective, easy and convenient to use and also suitable for substances having bitter taste and unpleasant odor.
  • composition of the present inventions may comprise one or more pharmaceutically acceptable excipient(s).
  • Pharmaceutically acceptable excipients comprise, but are not limited to, filler, disintegrant, binder, surfactant, lubricant, solvent and the mixtures thereof, to facilitate the physical formulation of various dosage forms for oral administration like capsules or tablets.
  • “pharmaceutically acceptable salt” refers to a salt of a compound that does not abrogate the biological activity and properties ofthe compound.
  • Pharmaceutical salts can be obtained by reaction of a compound disclosed herein with an acid or base.
  • Suitable disintegrants according to the present invention include, but are not limited to, carboxymethylcellulose calcium, carboxymethylcellulose sodium, croscarmellose (crosslinked carboxymethylcellulose) sodium, cross-linked polyvinylpyrrolidone, crospovidone (crosslinked povidone, a synthetic cross-linked homopolymer of N-vinyl-2-pyrrolidone), alginic acid, microcrystalline cellulose (such as refined wood pulp derived from alpha cellulose), hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, polacrillin potassium, sodium alginate, sodium starch glycolate, partially hydrolysed starch, sodium carboxymethyl starch, and starch.
  • Suitable binders according to the present invention include, but are not limited to, hydroxypropyl cellulose, hypromellose (hydroxypropyl methylcellulose, HPMC), HPMC E5, acacia, alginic acid, carboxymethylcellulose, methylcellulose, hydroxyethylcellulose, ethylhydroxyethylcellulose, carboxymethylcellulose sodium, methylcellulose, polyvinyl pyrrolidone and pregelatinized starch.
  • Suitable lubricants according to the present invention include, but are not limited to, calcium stearate, magnesium stearate, mineral oil, stearic acid, fumaric acid, sodium stearylfumarate, zinc stearate and polyethylene glycol.
  • the preferred lubricant is magnesium stearate.
  • Suitable fillers according to the present invention include, but are not limited to, dibasic calcium phosphate, kaolin, microcrystalline cellulose, silicated microcrystalline cellulose, dicalcium phosphate, tricalcium phosphate, magnesium trisilicate, lactose such as example the anhydrous form or the hydrate form such as the monohydrate form, sugars such as dextrose, maltose, saccharose, glucose, fructose or maltodextrine, sugar alcohols such as mannitol, maltitol, sorbitol, xylitol, powdered cellulose, precipitated calcium carbonate, sodium carbonate, sodium phosphate and starch. Fillers which are slightly hygroscopic or non- hygroscopic are preferred, with non-hygroscopic fillers being particularly preferred, in particular when the dosage form is to be used for tropical countries.
  • the preferred filler is microcrystalline cellulose.
  • Suitable surfactants and wetting agents include, but are not limited to, heptadecaethylene oxycetanol, lecithins, sorbitol monooleate, polyoxyethylene sorbitol monooleate, polyoxyethylene stearate, polyoxyethylen sorbitan monolaurate, benzalkonium chloride, nonoxynol 10, oxtoxynol 9, polysorbates, for example polysorbate 20, polysorbate 40, polysorbate 60 or polysorbate 80, sorbitan monopalmitate, sodium salts of fatty alcoholsulfates such as sodium lauryl sulfate, sodium dodecylsulfate, sodium salts of sulfosuccinates such as sodium dioctylsulfosuccinate, partially esters of fatty acids with alcohols such as glycerine monostearate, partially esters of fatty acids with sorbitans such as sorbitan monolaurate,
  • dissolution testing has been performed in pH 1.2 (O,1N HCI), acetate buffer pH 4.5, phosphate buffer pH 6.8.
  • Table 3 Summary of Dissolution Results of Pimavanserin 34mg Capsule (Test Product) in Comparison to Nuplazid 34mg Capsule (Reference Product) in acetat buffer pH 4.5.
  • the dissolution test has been performed for Nuplazid 34mg Capsule and
  • Pimavanserin 34mg Capsule (Test Product) in phosphate buffer pH 6.8 It is shown in Table 4 and Figure 5. Drug release for both the test product and the reference product were found to be satisfactory.
  • Table 4 Summary of Dissolution Results of Pimavanserin 34mg Capsule (Test Product) in Comparison to Nuplazid 34mg Capsule (Reference Product) in phosphate buffer pH 6.8.
  • the analytical method is the HPLC method for polymorphs of pimavanserin tartrate solubility study.
  • Table 5 Summary of pimavanserin tartrate polymorphs The highest of the Ctest given in the results are accepted as Cmax and the table are evaluated according to it.
  • Form A / Pimavanserin It is very well dissolved in all medias and sink condition is provided in all medias. During solubility, it was dissolved as pellets on the surface and in the solution. There was no precipitation in the solutions. It dissolved quickly without the need for a hot water bath.
  • Form C / Pimavanserin It is very well dissolved in all medias and sink condition is provided in all medias. While solubility, it became gel-like in the lower part of the solution and dissolved. Dissolution was slower than Form A/Pimavanserin and dissolved in a 37 °C hot water bath. There was no precipitation in the solutions.
  • w/w % refers to a percentage by weight compared to the total weight of the composition considered.
  • a pharmaceutical composition according to the invention is considered “stable”, if during a certain period of time 70%, preferably 80% and most preferably 95% of the initial content of pimavanserin, is maintained over said period of time.

Abstract

La présente invention concerne la préparation de compositions pharmaceutiques comprenant de la pimavansérine indiquée pour le traitement des hallucinations et délires associés à la psychose de la maladie de Parkinson, ayant un polymorphe spécifique avec d'autres excipients appropriés dans la formulation.
PCT/TR2021/051621 2021-12-30 2021-12-30 Compositions pharmaceutiques comprenant de la pimavansérine comme principe actif et excipients appropriés WO2023128900A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007133802A2 (fr) * 2006-05-15 2007-11-22 Acadia Pharmaceuticals Inc. Formules pharmaceutiques de pimavansérine
WO2016179569A1 (fr) * 2015-05-07 2016-11-10 Axovant Sciences Ltd. Compositions et méthodes de traitement d'une maladie neurodégénérative
WO2019025934A1 (fr) * 2017-08-02 2019-02-07 Kashiv Pharma Llc Composition pharmaceutique orale stable de pimavansérine
US20210177822A1 (en) * 2019-12-12 2021-06-17 Aurobindo Pharma Ltd. Pharmaceutical composition comprising pimavanserin, process of preparation and use thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007133802A2 (fr) * 2006-05-15 2007-11-22 Acadia Pharmaceuticals Inc. Formules pharmaceutiques de pimavansérine
WO2016179569A1 (fr) * 2015-05-07 2016-11-10 Axovant Sciences Ltd. Compositions et méthodes de traitement d'une maladie neurodégénérative
WO2019025934A1 (fr) * 2017-08-02 2019-02-07 Kashiv Pharma Llc Composition pharmaceutique orale stable de pimavansérine
US20210177822A1 (en) * 2019-12-12 2021-06-17 Aurobindo Pharma Ltd. Pharmaceutical composition comprising pimavanserin, process of preparation and use thereof

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