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WO1985003438A1 - Compositions eupeptiques et contenant des enzymes - Google Patents

Compositions eupeptiques et contenant des enzymes Download PDF

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Publication number
WO1985003438A1
WO1985003438A1 PCT/US1984/000159 US8400159W WO8503438A1 WO 1985003438 A1 WO1985003438 A1 WO 1985003438A1 US 8400159 W US8400159 W US 8400159W WO 8503438 A1 WO8503438 A1 WO 8503438A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
weight
beads
enzyme
pepsin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1984/000159
Other languages
English (en)
Inventor
Gerald L. Bilton
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.)
ADVANCED DRUG TECHNOLOGY Corp
Original Assignee
ADVANCED DRUG TECHNOLOGY Corp
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 ADVANCED DRUG TECHNOLOGY Corp filed Critical ADVANCED DRUG TECHNOLOGY Corp
Priority to PCT/US1984/000159 priority Critical patent/WO1985003438A1/fr
Priority to EP19840901130 priority patent/EP0172166A1/fr
Publication of WO1985003438A1 publication Critical patent/WO1985003438A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/488—Aspartic endopeptidases (3.4.23), e.g. pepsin, chymosin, renin, cathepsin E
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4873—Cysteine endopeptidases (3.4.22), e.g. stem bromelain, papain, ficin, cathepsin H
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Definitions

  • the acid serves to chemically break down food particles, to activate pepsin, to stimulate pancreatic secretion and to aid iron absorption.
  • Pepsin a protein produced by the gastric glands, enzymatically digests protein to proteoses and peptones in acid medium, resulting in the further liquefaction of food and reduction of food particle size.
  • Bile, pancreatic juice and intestinal juice are poured into the small intestine to complete the digestion of food begun in the mouth and stomach.
  • Bile delivered by the gall bladder, functions to emulsify, digest and to aid the gut absorption of the fatty acids resulting from the enzymatic hydrolysis of fats.
  • Pancreatic juice contains enzymes for digesting proteins, carbohydrates and fats. Among the proteolytic enzymes are trypsin and chymotypsin, which break down larger protein fractions into peptides.
  • Amylose converts starch into maltose and lipase splits fats into fatty acids and glycerin.
  • the pancreas also secretes bicarbonate anions, which neutralize stomach acid and provide an appropriate pH (7-11) for the action of the pancreatic enzymes.
  • Exocrine pancreatic insufficiency is commonly treated by the administration of pancreatic enzyme supplements, often in the form of enteric-coated preparations which resist degradation by stomach acid and pepsin.
  • Other substances such as bile salts, additional proteolytic enzymes, cellulase, hemicellulase and simethicone may be included in varying amounts when the additional goal of treating postprandial abdominal distress symptoms is desired.
  • These symptoms which include bloating, pain, nausea, and excess intestinal gas production, may be pathological in origin or merely be due to dietary indiscretion or to "nervous indigestion" .
  • the composition of a number of these products and their modes of action has been described by D. Y. Graham, Enzyme Therapy of Digestive Disorders in Enzymes As
  • compositions suitable for alleviation of digestive dysfunction due to pancreatic insufficiency, postprandial distress, and the like which are suitable for oral administration.
  • compositions which comprise effective amounts of pepsin, a hydrochloric acid source, a source of pancreatic enzymes, a proteolytic enzyme of plant origin and a choleretic agent.
  • the proteolyt ic enzymes and pancreatic enzymes are adhered to sugar beads which are further coated so as to render them resistant to gastric acid, whereas the other components are formulated so as to be readily released and/or solubilized in the stomach.
  • pepsin and an acid source are available to enhance the digestive action of the stomach juices
  • bile salts are made available to aid in gut fat absorption
  • pancreatic and proteolytic enzymes are provided in an active form to the small intestine to augment the digestion of fats, proteins and starches.
  • These components may be combined with minor amounts of suitable inert adjuvants and tabletted, or encapsulated in powdered form.
  • pancreatic extracts are used in the compositions of the present invention to provide a source of the pancreatic enzymes such as lipase, amylase and protease When delivered in an active form to the small intestine, these pancreatic enzymes act to break down fats, starches and proteins, respectively, into components which can be absorbed by the body.
  • pancrease extracts will comprise about 5.0- 25% by weight of the present compositions, most preferably 10-20%.
  • pancreatic extracts employed in the present compositions will possess some degree of proteolytic activity
  • additional amounts of proteolytic enzymes such as the plant-derived proteolytic enzymes bromelain, papain, ficin and mixtures thereof are used in the present compositions to optimize their effectiveness in reducing postprandial digestive syndrome and for reducing the symptoms of episeotomy.
  • Bromelain is the preferred proteolytic enzyme to be used in the present compositions, and may comprise about 2.5-15%, preferably 5-10% by weight of the composition.
  • Choleretic digestants useful in the compositions of the present invention include bile, bile acids and bile salts, with desiccated bile extracts, e.g., ox bile extracts, being preferred.
  • desiccated bile extracts e.g., ox bile extracts
  • bile salts When administered orally, bile salts are absorbed from the intestine and reexcreted by the liver in the bile, thus entering the same cyclic process as endogenous bile salts. They are of value in promoting the absorption of fats and fat- soluble vitamins from the intestinal tract when the normal biliary or pancreatic output is either reduced or absent.
  • Bile salts will preferably comprise about 2.5- 15%, preferably 5-10% by weight of the present compositions.
  • compositions of the present invention will also comprise about 5-25%, preferably 10-20% of a hydrochloric acid source, preferably as an organic hydrochloride salt such as glutamic acid hydrochloride or betaine hydrochloride.
  • Hydrochloric acid acts in the gastrointestinal tract to activate pepsin, render gastric contents relatively sterile, aid in the secretion of pancreatic juices and allow the absorption of certain inorganic salts.
  • Hydrochloric acid salts are effective in relieving symptoms due to hyperchlorhydria or achlorhydria, conditions which may be genetic or due to gastritis or gastric carcinoma, respectively.
  • compositions of the present invention will also include an effective amount of pepsin, preferably as the N.F. grade, although grades of higher activity may also be used.
  • Pepsin acts in the stomach to hydrolyze proteins into polypeptides and amino acids, and thus acts in concert with the bromelain and the pancreatic proteolytic enzymes to restore and maintain the body's amino acid balance.
  • pepsin will comprise about 5-25%, most preferably 10-20% of the present compositions.
  • the above-described active ingredients preferably will comprise about 40-80%, and most preferably 45-75% by weight of the present compositions before the addition of adjuvants and tabletting.
  • the pancreatic enzymes and the other proteolytic enzymes i.e., the bromelain or papain
  • the pancreatic enzymes and the other proteolytic enzymes are readily degraded and deactivated under conditions of low pH, they must be incorporated into the present compositions in a manner which will protect them from stomach acid and deliver them rapidly to the small intestine.
  • the pepsin, bile salts and hydrochloric acid salts should be formulated so as to be quickly released in the stomach.
  • the pancreatic extract and additional proteolytic enzyme are adhered onto and/or absorbed into digestible beadlets which may be formed of substances such as sugars, starches and the like.
  • the beadlets are sized so as to pass readily through the stomach into the small intestine, i.e., to be carried through and out of the stomach by the normal flow of digestive juices, and are coated so that they will maintain their integrity in the stomach but rapidly disintegrate in the small intestine.
  • a sugar-starch Nupareil ® bead (Specialty Food Products,
  • Pennsauken, New Jersey about 0.1-0.2 mm in diameter will have a coated diameter within the useful range of about 0.3-0.5 mm.
  • the acid-stable components of the composition are agglomerated and mixed with the coated beadlets and the mixture encapsulated or compressed into tablets with suitable adjuvant fillers, lubricants, and coating materials.
  • tablets prepared in the above-described manner will comprise about 35-75%, and most preferably 40-70% by weight of the active ingredients described hereinabove.
  • the pancreatic extracts and additional plant-derived proteolytic enzymes will comprise about 20-75%, preferably about 30-50% by weight of the total active ingredients, and will be adhered to and/or absorbed into digestible beadlets which will, when loaded with enzymes and enteric-coated, comprise about 35-65%, preferably about 45-55% by weight of the finished tablets.
  • the pancreas extracts and bromelain (or papain) will be used in about a 2:1 weight ratio.
  • Any coating composition which will maintain the integrity of the enzyme-treated beads in gastric juice for at least about 1-2 hours may be applied to protect the beads using methods and formulations well known to those of skill in the pharmaceutical coating arts.
  • suitable enteric-coating materials are discussed in Remington's Pharmaceutical Sciences, A. Osol, ed., Mack Pub. Co., Easton, Pa. ( 16th ed. 1980) at pages 1590-1593, the disclosure of which is incorporated by reference herein.
  • Mixtures of fats and fatty acids are preferred, preferably about a 1:1 to 5:1 mixture of stearic acid and carnauba wax, which is added to the beadlets while they are being sprayed with a food glaze-alcohol solution.
  • the acid-resistant coating will preferably comprise about 5-20% by weight of the finished bead, although the coating could be thinner in cases involving the treatment of patients with extremely low stomach acidity.
  • a mixture of about 30-50%, preferably 35-45% by weight of a mixture of bile extract, pepsin and an organic hydrochloride salt, preferably in a weight ratio of about 1:2:2 is prepared in the presence of about 15-25% water and about 0.5-5% of a binder (i.e., guar gum).
  • a binder i.e., guar gum.
  • the resultant mixture is coarse-screened, dried and ground to a particle size of about 0.5-2.0 mm in diameter, or about 10-16 mesh (U.S. Standard Sieve Series).
  • the granules are combined with the coated beads and encapsulated or, optionally, further combined with suitable amounts of filler and lubricant and compressed into tablets.
  • the tablets may be further finish-coated, for example, with zein, wax, and/or sugar.
  • the hereinabove described formulation steps are carried out under conditions resulting in no more than about a 10% loss in the activity of any given enzymatic component, as measured
  • compositions of the present invention will comprise, before the addition of tabletting adjuvants, about 50-70% by weight of enzyme-treated, coated sugar beadlets which have absorbed therein or coated thereon about 10-20% by weight of pancreatin, and about 5-10% by weight of one or more plant proteolytic enzymes.
  • the beadlets are mixed with about 35-45% of a granulated mixture of bile salt, pepsin and an organic hydrochloride which have been agglomerated in the presence of 0.5-5% of a binding agent.
  • the bile, pepsin and acid are present in weight ranges of about 5-10%, 10-20% and 10-20%, respectively, all weights being expressed as per cent of the entire composition.
  • compositions of the present invention comprise the above-described compositions which have been compressed into tablets in the presence of about 5-15% of a mixture of biologically inert adjuvants comprising lubricants, fillers and coatings.
  • Acceptable lubricants comprise mixtures of hydrogenated vegetable oils of conventional pharmaceutical grade and fatty acid salts, magnesium stearate, i.e., in about a 2:1 ratio (about 5-10% by weight of the finished tablet).
  • Fillers such as microcrystalline cellulose, calcium sulfate and sugars may be used, preferably in amounts of about 1-10% by weight of the finished tablets.
  • a finish coating of zein (whole corn protein; Chicago Specialty, Chicago, Illinois) may further be applied and the tablets buffed if desired.
  • a stainless steel coating pan was loaded with 32.5 kg of Nupareil ® sucrose/starch beads and agitation begun.
  • kg denatured ethanol was prepared and continuously pressure-sprayed onto the beads while 12.5 kg of bromelain and 25.0 kg of pancreatin powder were added to the moving beads. Agitation was continued while a mixture of 3.25 kg of stearic acid and 3.25 kg of carnauba wax were added portion wise to the beads to provide a coating layer.
  • Talc was added as necessary to prevent agglomeration of the beads.
  • Rounded beads were obtained of an average diameter of 0.3-0.5 mm.
  • a mixture of 12.5 kg ox bile extract, 2.5 kg of pepsin N.F., 25 kg of betaine hydrochloride and 2.5 kg of guar gum was ribbon blended with about 7.5 kg of water to form a dough which was screened (6 mesh) and dried in a hot air oven at 50°C.
  • the resultant granules were ground in a Fitz mill, then dry-screened to a 16 mesh size.
  • the granules were mixed with the coated beads in the coating pan and blended with 2.5 kg hydrogenated vegetable oil, 3.75 kg of microcrystalline cellulose and 12.5 kg of magnesium stearate.
  • the bead-containing mixture was punched into about 250,000 600 mg tablets on a tablet punch equipped with standard concave (7/16 inch) tooling.
  • the tablets were then returned to the coating pan and spray-coated with a solution of 7.5 g of zein (1% in ethanol) , followed by drying for 1.5 hours and bottling.
  • the bead-granule mixture is encapsulated in 500 mg gelatin capsules prior to treatment with the lubricants and fillers.
  • coated beads present in either the tabletted or encapsulated preparation resisted disintegration in 1.2N hydrochloric acid stirred at 30 rpm for at least one hour, thus demonstrating the stability of the coating.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Composition conçue pour soulager les symptômes d'un dérèglement digestif, contenant un mélange de perles enduites incorporant des enzymes pancréatiques et des enzymes protéolitiques, surmonté d'un revêtement résistant aux acides gastriques, lesdites perles étant administrées par voie orale en combinaison avec des granules comportant un agent cholérétique, un sel d'acide chlorhydrique et une pepsine.
PCT/US1984/000159 1984-02-03 1984-02-03 Compositions eupeptiques et contenant des enzymes Ceased WO1985003438A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/US1984/000159 WO1985003438A1 (fr) 1984-02-03 1984-02-03 Compositions eupeptiques et contenant des enzymes
EP19840901130 EP0172166A1 (fr) 1984-02-03 1984-02-03 Compositions eupeptiques et contenant des enzymes

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1984/000159 WO1985003438A1 (fr) 1984-02-03 1984-02-03 Compositions eupeptiques et contenant des enzymes

Publications (1)

Publication Number Publication Date
WO1985003438A1 true WO1985003438A1 (fr) 1985-08-15

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1984/000159 Ceased WO1985003438A1 (fr) 1984-02-03 1984-02-03 Compositions eupeptiques et contenant des enzymes

Country Status (2)

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EP (1) EP0172166A1 (fr)
WO (1) WO1985003438A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4332985A1 (de) * 1993-09-28 1995-03-30 Konrad Peter Maria Dr Sommer Arzneimittel zur Behandlung der Dysfunktion des exokrinen Pankreas
WO1999000141A1 (fr) * 1997-06-27 1999-01-07 Provalis Uk Limited Utilisation de la bromelaine pour la fabrication d'un medicament renforçant la permeabilite intestinale
US7833963B2 (en) 1997-02-25 2010-11-16 Sarantis Pty Ltd Component of bromelain
US8071089B2 (en) 2005-11-01 2011-12-06 Bio-Cat, Inc. Composition with a fungal (yeast) lipase and method for treating lipid malabsorption in cystic fibrosis as well as people suffering from pancreatic lipase insufficiency
CN111317126A (zh) * 2018-12-14 2020-06-23 解冰 一种用于恢复和保持消化功能的木瓜酵素组合物及制备方法和复合纳米制剂

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8211375B2 (en) 2009-10-07 2012-07-03 Chevron U.S.A. Inc. Flow distribution device for downflow catalytic reactors

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3003917A (en) * 1959-01-14 1961-10-10 Nat Drug Co Wound healing composition
US3004893A (en) * 1959-10-21 1961-10-17 Richardson Merrell Inc Enteric coated trypsin and chymotrypsin anti-inflammatory compositions
US3860702A (en) * 1972-07-11 1975-01-14 Schuyler Dev Corp Anti-inflammatory compositions
US3932618A (en) * 1971-04-14 1976-01-13 Otsuka Kagaku Yakuhin Kabushiki Kaisha Anti-inflammatory compositions
US4079125A (en) * 1975-06-10 1978-03-14 Johnson & Johnson Preparation of enteric coated digestive enzyme compositions

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3003917A (en) * 1959-01-14 1961-10-10 Nat Drug Co Wound healing composition
US3004893A (en) * 1959-10-21 1961-10-17 Richardson Merrell Inc Enteric coated trypsin and chymotrypsin anti-inflammatory compositions
US3932618A (en) * 1971-04-14 1976-01-13 Otsuka Kagaku Yakuhin Kabushiki Kaisha Anti-inflammatory compositions
US3860702A (en) * 1972-07-11 1975-01-14 Schuyler Dev Corp Anti-inflammatory compositions
US4079125A (en) * 1975-06-10 1978-03-14 Johnson & Johnson Preparation of enteric coated digestive enzyme compositions

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4332985A1 (de) * 1993-09-28 1995-03-30 Konrad Peter Maria Dr Sommer Arzneimittel zur Behandlung der Dysfunktion des exokrinen Pankreas
US7833963B2 (en) 1997-02-25 2010-11-16 Sarantis Pty Ltd Component of bromelain
US9663777B2 (en) 1997-02-25 2017-05-30 Sarantis Pty Ltd Component of bromelain
WO1999000141A1 (fr) * 1997-06-27 1999-01-07 Provalis Uk Limited Utilisation de la bromelaine pour la fabrication d'un medicament renforçant la permeabilite intestinale
US8071089B2 (en) 2005-11-01 2011-12-06 Bio-Cat, Inc. Composition with a fungal (yeast) lipase and method for treating lipid malabsorption in cystic fibrosis as well as people suffering from pancreatic lipase insufficiency
CN111317126A (zh) * 2018-12-14 2020-06-23 解冰 一种用于恢复和保持消化功能的木瓜酵素组合物及制备方法和复合纳米制剂

Also Published As

Publication number Publication date
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