US20080254119A1 - Imbedded liquid lubricants for tableting - Google Patents
Imbedded liquid lubricants for tableting Download PDFInfo
- Publication number
- US20080254119A1 US20080254119A1 US11/787,381 US78738107A US2008254119A1 US 20080254119 A1 US20080254119 A1 US 20080254119A1 US 78738107 A US78738107 A US 78738107A US 2008254119 A1 US2008254119 A1 US 2008254119A1
- Authority
- US
- United States
- Prior art keywords
- composition
- oil
- matrix
- nutritional supplement
- vitamin
- 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.)
- Abandoned
Links
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- 239000011159 matrix material Substances 0.000 claims abstract description 106
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- 238000000034 method Methods 0.000 claims abstract description 40
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- 238000005461 lubrication Methods 0.000 claims abstract description 38
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 24
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- 230000001050 lubricating effect Effects 0.000 claims abstract description 9
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- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/15—Vitamins
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
-
- 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
Definitions
- This invention relates to pharmaceutical and nutriceutical tablets. More particularly the invention provides a composition and method for effective lubrication in tableting.
- Stearic acid or metallic salts of stearic acid are commonly used as an excipient in pharmaceutical and nutriceutical compositions to facilitate the tableting process.
- Compounds such as magnesium stearate function as a lubricant and facilitate tableting by reducing friction at the tablet-die wall interface during tablet formation and ejection, and/or by preventing sticking to punch faces and the die wall.
- Magnesium stearate is a laminar lubricant.
- As a laminar lubricant the structure of magnesium stearate is a stack of laminar sheets. Lubrication occurs when one or more laminar sheets are “peeled off” the stack and at least partially coat surrounding particles. Mixing facilitates removal of sheets from the stack and accordingly the degree of lubrication (i.e. lubrication with a laminar lubricant is “mixing sensitive”).
- the laminar sheets peel off from the stack structure of magnesium stearate and coat the surrounding particles or granules of the composition. Accordingly, the mixing time, speed and/or mixing method impact the lubricating efficacy of magnesium stearate. For example, if too many laminar sheets peel off from the stack structure of magnesium stearate in the mixing process over lubrication occurs. Namely, particles get over coated with laminar sheets which reduce interparticular bonding leading to poor compressibility and lower tablet hardness, thus creating potential processing problems and/or the propensity for malformed tablet. In some cases over lubrication can render the tablet hydrophobic which may lengthen disintegration time undesirably.
- magnesium stearate is typically added to the composition in a separate last step before tableting to provide control of the lubrication process and minimize the opportunity for over-lubrication or undesirable disruption of the magnesium stearate structure in the mixing process.
- liquid lubricants have not been particularly useful in powder blend compositions of nutriceuticals and/or pharmaceuticals intended for tableting.
- liquid lubricants can only be added in small quantities to powder blends and must be added immediately prior to compression because they tend to wet the powder blends rendering mixing difficult.
- a second approach used to facilitate use of liquid lubricants in dry mixtures intended for tableting was to coat liquid lubricants with an oil-insoluble film-forming substance to avoid the wetting issue.
- the film forming material assembles to form a layer or skin over the surface of an oil droplet.
- Film forming substances as set forth in U.S. Pat. No. 3,518,343 include water soluble gums such as gum Arabic, pectin, traganth, modified celluloses such as hydroxypropyl cellulose or carboxymethyl cellulose, alginates or proteinaceous material such as gelatin. While the oil insoluble film-former may address the wetting issue to some extent, the film-coated liquids known in the art have substantially decreased lubrication efficiency as the lubricant is encased in the film.
- compositions and/or method for improved lubrication of dry nutriceutical and/or pharmaceutical compositions for tableting is needed.
- the invention provides a nutritional supplement tablet composition comprising an embedded lubrication matrix.
- the embedded lubrication matrix comprises an oily liquid finely dispersed in an oil insoluble material.
- the nutritional supplement composition is substantially free of stearate.
- Oily liquids suitable for dispersion in the oil insoluble material include, but are not limited to, Vitamin E, animal oil, synthetic oil, mineral oil, polyethylene glycol, silicon oil and combinations thereof.
- Suitable oil insoluble materials include, but are not limited to, starch, dextrin, microcrystalline cellulose, ethylcellulose, gelatin, sugars, glucose, maltose, fructose, sorbitol, sucrose, mannitol, sorbitol, lactose, methylcellulose, hydroxypropylmethyl cellulose, maltodextrin, silicon dioxide, anhydrous dicalcium phosphate, and combinations thereof.
- the composition may be a direct compression, roller compaction or granulation composition.
- One embodiment of the invention provides a pharmaceutical composition for tableting comprising an embedded lubrication matrix wherein the embedded lubrication matrix comprises an oily liquid dispersed in an oil insoluble base material, and wherein the pharmaceutical composition is substantially free of stearate.
- a method of lubricating a nutritional supplement or pharmaceutical composition for tableting comprises providing a matrix with embedded liquid lubricant, providing a nutritional supplement composition or pharmaceutical composition, mixing the matrix with embedded liquid lubricant and the nutritional supplement or pharmaceutical composition, and forming a tablet.
- the nutritional supplement or pharmaceutical composition may be a direct compression mixture, a roller compaction mixture or comprise a granulation.
- the present invention provides a composition comprising a matrix with embedded liquid lubricants.
- the embedded liquid lubricants serve to provide lubrication for tableting of the composition.
- the matrix with embedded liquid lubricant of the invention is an oil-insoluble-particulate-solid base material having a viscous oily liquid lubricant dispersed in the base material.
- the matrix with embedded liquid lubricant may be used as an alternative to metal stearate lubricants such as magnesium stearate as a tableting lubricant for nutriceutical or pharmaceutical compositions.
- the matrix with embedded lubricant may be used as a partial replacement for stearate lubricants or other tableting lubricants.
- the matrix with embedded lubricant is a useful lubricant for tableting dry nutritional and/or pharmaceutical compositions such as, for example, vitamin and/or mineral compositions.
- the matrix with embedded lubricant is particularly useful for compositions subjected to direct compression in the tableting process.
- liquid Vitamin E acetate finely dispersed in a starch/dextrin matrix was found to effectively lubricate a multi-vitamin and mineral formulation for direct compression.
- Embodiments having Vitamin E as the lubricant embedded in the matrix may provide the additional benefits of antioxidant activity and/or nutritional supplementation of Vitamin E.
- the invention further includes a method of lubricating a nutritional or pharmaceutical composition for tableting by providing a matrix with embedded liquid lubricant, and a nutritional supplement or pharmaceutical composition, and mixing the matrix with embedded liquid lubricant with the nutritional supplement or pharmaceutical composition prior to tableting.
- the inventors believe without wishing to be bound to the theory that embedding a liquid lubricant in a matrix allows the liquid lubricant to be evenly distributed in the matrix without wetting the matrix.
- the liquid lubricant may be extruded from the matrix and provide lubrication for tableting, eliminating the over-lubrication issues seen with stearic acid and metal stearates. Since the liquid lubricant in a matrix does not have mixing related over-lubrication issues, it can be added with other components for mixing in a single step. Thus, the conventional step of adding lubricant as a separate step immediately before tableting can be avoided.
- matrix with embedded liquid lubricants means a composition comprising at least one oily liquid finely dispersed in an oil insoluble material wherein the matrix appears to be dry and no oil or oily appearance is visible to the human eye and the matrix is free flowing. Small particles of oil are incorporated in the mass of the oil insoluble material (e.g. interspersed in the interstitial spaces of the oil insoluble material.) The lubricant may be displaced from the matrix by the compression forces of the tableting process.
- the oil insoluble material may be a single component or mixture of components. Typically, the oil insoluble material is in the form of dry particles.
- the oily liquid may be a single entity or a mixture of oily liquids.
- Each of the materials comprising the matrix with embedded liquid lubricants should be a material that is acceptable for consumption by a mammal.
- oil means a substance that is substantially insoluble in water (as designated by the Merck Index, CRC Handbook or MSDS Data sheet) and that is a liquid at ambient temperatures.
- An “embedded liquid lubricant” includes oils as well as other materials which are liquids at ambient temperatures, have lubricating properties, and do not react with or solubilize the oil insoluble material.
- Embedded liquid lubricants are distinguished from film-coated lubricants in that there is no chemical or physical process that causes the oil insoluble material to assemble a layer over the surface of an oil droplet.
- a simple listing of oil insoluble materials suitable for forming a matrix and a listing of film forming polymers may over lap; however, chemical identity alone is not dispositive.
- the method of combining, proportions used, the presence of other reactive entities, amount of moisture and temperature are exemplary of factors that may determine whether a film-coated oil is formed or a matrix with embedded lubricant is formed.
- stearate(s) includes stearic acid and metallic salts of stearic acids.
- Magnesium stearate is an exemplary metallic salt of stearic acid.
- Substantially, free of stearates means that the composition comprises less than 0.01% stearate by weight.
- multivitamin and mineral or “multivitamin and multimineral” supplement(s) includes compositions comprising, at least one vitamin and at least one mineral and optionally one or more related nutritional agent.
- multivitamin and mineral or “multivitamin and multimineral” should be interpreted in a like manner herein when they proceed the terms “supplement”, “tablet”, or “composition”. Additionally multivitamin and mineral supplement is an example of nutritional supplement and/or a nutriceutical.
- Nutritional agents include substances other than vitamins and minerals known to have health benefits.
- Nutritional agents include, but are not limited to, carotinoids (such as lutein, lycopene, zeaxanthin, astaxantin, and related xanthanins), fiber, phytosterols, glucosides, polyphenols, B complex related compounds (such as choline and inositol), omega-3 fatty acids, probiotics, glucosamine, herbals, amino acids and peptides.
- disintegration time means the amount of time it takes for a tablet dosage unit of a pharmaceutical composition or nutritional supplement to disintegrate under controlled laboratory conditions.
- disintegration time means the amount of time it takes for a tablet dosage unit of a pharmaceutical composition or nutritional supplement to disintegrate under controlled laboratory conditions.
- One of ordinary skill in the art is familiar with methods and procedures for determination of disintegration times.
- dry pharmaceutical composition refers to a composition that is presented as a dry material for compressing into a tablet dosage form. While the composition is dry at the time of compression into a tablet, processing steps that involve moisture are not precluded so long as the material is not overtly moist at the time it is presented for tableting.
- pharmaceutical active(s) As used herein the terms “pharmaceutical active(s)”, “active(s)”, “active agent(s)”, “therapeutic agent(s)”, drug(s)” should be considered to be equivalent terms and taken to mean a substance used in the prevention, diagnosis, alleviation, treatment, or cure of disease or medical condition.
- composition of the invention may comprise any nutritional or pharmaceutical composition, which may be formed into a tablet dosage form.
- Compositions with a plurality of nutritional components and/or pharmaceutical actives are also within the scope of the invention.
- the composition may comprise a single nutritional component, a select group of components (such as, for example, a group of nutrients directed to bone health), or a wide spectrum of nutritional components such as vitamins and minerals, and optionally, one or more nutritional agents (such as, for example, commercial multivitamin and mineral tablets or multivitamin and mineral tablets with one or more added nutritional agents.)
- Suitable vitamins and related entities which may be included in the compositions of the invention include, but are not limited to, Vitamin C, Vitamin E, thiamin (Vitamin B 1 ), riboflavin (Vitamin B 2 ), niacin (Vitamin B 3 ), pyridoxine (Vitamin B 6 ), folic acid, cobalamins (Vitamin B 12 ), Pantothenic acid (Vitamin B 5 ), Biotin, Vitamin A (and Vitamin A precursors), Vitamin D, Vitamin K, and other B complex vitamins, and mixtures thereof.
- Suitable minerals which may be included in the composition of the invention include, but are not limited to, iron, iodine, magnesium, zinc, selenium, copper, calcium, manganese, silicon, molybdenum, vanadium, boron, nickel, tin phosphorus, chromium, cobalt, chloride, potassium and combinations thereof.
- Mineral components of multivitamin-multimineral tablets are typically provided in salt form.
- the salt form used should be a pharmaceutically acceptable salt form.
- a listing of vitamins and minerals and related agents that may be included in nutritional supplements and dosage amounts are set forth in established reference guides such as the United States Pharmacopeia National Formulary Official Compendium of Standards (i.e., the U.S.P. N.F. Official Compendium of Standards) or European Directive 90/496/EC including amendments which are incorporated herein by reference.
- Amounts of vitamins and minerals may vary in specific embodiments but should typically fall within the dosage amounts set forth in the U.S.P. N.F. Official Compendium of Standards or European Union Directive
- Nutritional agents which may be included in the composition of the invention include, but are not limited to, carotinoids (such as lutein, lycopene, zeaxanthin, astaxanthin, and related xanthins), B complex related compounds such as choline and inositol, for example, fiber, phytosterols, probiotics, glucosides, polyphenols, choline, omega-3 fatty acids, glucosamine, herbals, amino acids and peptides.
- carotinoids such as lutein, lycopene, zeaxanthin, astaxanthin, and related xanthins
- B complex related compounds such as choline and inositol, for example, fiber, phytosterols, probiotics, glucosides, polyphenols, choline, omega-3 fatty acids, glucosamine, herbals, amino acids and peptides.
- compositions of the invention further comprise a matrix with embedded liquid lubricant.
- the matrix comprises a base material portion and an oily liquid.
- the base material portion is an oil insoluble material.
- Oil insoluble materials suitable for the base material portion include, but are not limited to, starch, dextrin, microcrystalline cellulose, ethylcellulose, gelatin, sugars, glucose, maltose, fructose, sorbitol, sucrose, mannitol, sorbitol, lactose, methylcellulose, hydroxypropylmethyl cellulose, maltodextrin, silicon dioxide, anhydrous dicalcium phosphate, and combinations thereof.
- Suitable oily liquids include, but are not limited to, Vitamin E, animal oil, synthetic oil, mineral oil, organic liquid with lubricating function, polyethylene glycol, silicon oil and combinations thereof.
- a processing aid such as, for example, silicon dioxide.
- the base material should be in a substantially particulate state in the matrix such that interparticulate spaces (or interstitial spaces) are available for receiving the small particles or fine droplets of the lubricant.
- the oily liquid is finely dispersed in the base material. Dispersion of the oily liquid in the base material should be such that the matrix appears to be dry and no oil or oily appearance is visible to the human eye and the matrix is free flowing.
- the amount of oily liquid dispersed in the base material will typically be up to about 70% wt/wt oil to oil plus base material. Typically about 10% to about 55% wt/wt oil to oil plus base material is convenient for maintaining the properties of the matrix and providing optimized quantities of lubricant per amount of matrix used in the tableting composition. These amounts are representative and other amount may be likewise suitable with the specific amount being dependent on the nature of the base material and oily liquid used, flow properties, and/or degree of lubrication desired.
- Vitamin E acetate from a starch maltodextrin base material under compression differs from the release of Vitamin E acetate from a starch gelatin base material under compression.
- adjusting the ratio of oil to matrix base and/or adding processing aids such as silicon dioxide, for example, are exemplary of methods that may be used to modulate the flow properties.
- the matrix is to be used in a composition intended for direct compression, preferably at least 70% of the matrix will have particle sizes that fall in the range of about 20 mesh (850 microns) to about 200 mesh (75 microns) as measured by US standard sieves. Additionally, for direct compression, the matrix with embedded lubricant will preferably have a Carr compressibility Index value of about 5 to about 21.
- Amounts of matrix used will depend on amount of lubrication needed which, in turn, is a function of the chemical and physical properties of activities and excipients in the composition.
- amounts of lubricant as low as about 0.1% to about 1.5% wt/wt of a matrix which is 50% by weight of lubricant may provide sufficient lubrication, for example.
- the dispersion of the oily liquid in the base material may be accomplished with mixing.
- Base material particle size, speed of mixing and mechanism of mixing are exemplary of parameters which may be modified to achieve the desired dispersion.
- small base material particle size and high shear mixing may be used to create the fine dispersion in which the oil is not visible to the human eye.
- Other methods such as spray processes, for example may be likewise suitable to finely disperse the oily liquid in the base material.
- the base material comprises one or more materials that may react or assemble to form films under certain conditions, the method selected for preparing the matrix with embedded lubricant should avoid processing steps and or addition of substances that would lead to film formation.
- Vitamin E may have some advantages over other traditional lubricating oils. Most traditional lubricating oils contain trans fats, which are associated with an increased risk of coronary heart disease. On the contrary, Vitamin E has been suggested to also assists in healthy heart and blood vessels. Furthermore, Vitamin E is widely acknowledged as a powerful antioxidant. Vitamin E is used as a supplement to prevent the destructive impacts of free radicals in human. Also Vitamin E is widely used as a preservative in a variety of consumer goods to maintain quality and/or prevent undesirable reactions and extend shelf life. Vitamin E may be used in free form or in a derivatized form such as, for example, Vitamin E acetate.
- a matrix with embedded Vitamin E is widely applicable as a tableting lubricant.
- a matrix with embedded vitamin E can effectively lubricate a direct compression multi-vitamin/mineral formulation, which contains high levels of abrasive metal salts. Abrasive materials such as metal salts are believed to make lubrication difficult.
- the matrix with embedded Vitamin E can be an effective sole lubricant for the multi-vitamin/mineral formulation, or the matrix with embedded vitamin E may be employed in conjunction with another lubricant for various tabletable formulations.
- a matrix with vitamin E embedded is also suitable for use in compression blends with less abrasive materials, compositions subjected to roller compaction or in granulation compositions subjected to tableting.
- compositions in accordance with the present invention are intended for oral administration in a solid form (i.e. tablet).
- the composition may further comprise excipients and/or processing aides in addition to vitamins and minerals.
- excipients and processing aids include but are not limited to, absorbents, diluents, flavorants, colorants, stabilizers, fillers, binders, disintegrants, glidants, antiadherents, sugar or film coating agents, preservatives, buffers, artificial sweeteners, natural sweeteners, dispersants, thickeners, solubilizing agents and the like or some combination thereof.
- stearic acid and/or metal stearate lubricants are not included as excipients.
- the nutritional compositions of the invention may be prepared by combining the matrix with embedded lubricant with the vitamin(s) and/or mineral(s) and/or nutritional agent(s) intended for inclusion in the tablet dosage form and tableting excipients.
- the matrix with embedded lubricant is not mixing sensitive, the timing and/or manner of a addition of the matrix with embedded lubricant is not critical. Accordingly, a special addition step or steps for addition of the lubricant and/or special mixing provisions for the lubricant are not required.
- the composition thus prepared may be fed into a tablet press and formed into tablets.
- the compression forces of the tablet press are sufficient to extrude lubricant from the matrix to permit lubrication.
- the matrix with embedded lubricant is well suited for use with direct compression blends (e.g. compositions prepared for direct compression).
- a matrix with embedded lubricants may likewise be useful for lubrication of granulation blends intended for tableting or compositions prepared by roller compaction as the lubrication function is achieved as the composition is pressed into a tablet.
- compositions of pharmaceutical actives for tableting utilizing a matrix with embedded lubricant as a tableting lubricant may be prepared as described above for the nutritional compositions.
- a matrix with embedded lubricant is Vitamin E acetate dispersed in a base material of equal parts of modified food starch and maltodextrin.
- the ratio of vitamin E to base material is about 50/50 by weight.
- Silicon dioxide may be included in the matrix as a processing aid. Typically the processing silicon dioxide processing aid would be included in an amount of about 0.2 to 2.5%.
- the vitamin E, starch, maltodextrin and processing aid should be mixed such that the oily viscous vitamin E is finely dispersed in the starch maltodextrin base material and no liquid or viscous material is visible to the human eye. Mixing may be accomplished using a high shear mixer or alternatively a spray system.
- the mixing method should yield a matrix in the form of a free flowing powder. Once prepared, the matrix with embedded lubricant may then be combined with the material to be tableted.
- This composition is representative of the many matrix compositions that are within the scope of the invention and is provided for illustrative purposes.
- Table 1 An example of a nutritional supplement composition of an exemplary embodiment of the invention is provided in Table 1.
- This composition is representative of the many compositions that are within the scope of the invention and is provided for illustrative purposes.
- the exemplary composition of Table 1 is a multivitamin and mineral supplement.
- the matrix with embedded lubricant is vitamin E finely dispersed in a starch maltodextrin base (50% w/w) with silicon dioxide as a processing aid as described in Example 1.
- the amount of matrix with embedded lubricant was varied from 0.3% to 8.8% for the individual samples of the nutritional supplement composition and accordingly is listed as a range of amounts in Table 1.
- the matrix with embedded lubricant was the sole lubricant in the composition (e.g. no magnesium stearate or other tableting lubricant was added.
- the composition of the formulation provided in Table 1 is stated as the weight (mg) of each component per tablet.
- the above ingredients were passed through a No. 20 (U.S. Standard Mesh) hand screen, and blended together using a V-blender in a single step. All samples were mixed identically except for the amount of matrix with embedded lubricant added.
- the resulting compression mixtures with various concentrations of the matrix with embedded lubricant (Vitamin E) were paddle-fed into the dies for compression using a Manesty Beta Press and modified oval shape tablet tooling. Compression forces were targeted at 30, 40, and 50 kN, with a pre-compression force of about 8 kN and press speed at 85 rpm.
- the tablets were 0.330 inch wide, 0.745 inch long and approximately 0.280 inch thick (with slight variation in size do to the varying amounts of matrix with embedded lubricant used).
- the Manesty Betapress was instrumented to monitor both compression force and ejection force, and recorded results using MCC software. Tablets were evaluated for hardness by Hardness Tester (Dr. Schleuniger Pharmatron, Model 6D-500N), friability by Vanderkamp Friabilator (Van-Kel Industry, Model 10809), weight by Analytical Balance and thickness by Caliper.
- the Vitamin E matrix performed well as the sole lubricant with minimal impact on tablet hardness, friability, and disintegration time (DT).
- the compression mixtures were found to be well lubricated for compression and subsequent ejection from the dies with a minimum of 0.3% matrix with embedded Vitamin E by weight (or 0.15% Vitamin E), and smooth surfaced and elegant in appearance with a minimum of 1.2% Matrix with embedded Vitamin E (or 0.6% Vitamin E). 0.3% of matrix with embedded Vitamin E was sufficient for providing equivalent ejection forces as a comparable vitamin and mineral supplement in which 0.3% Magnesium stearate is used as the lubricant.
- the matrix with embedded Vitamin E was found to decrease the friability by approximately 50% at all concentrations tested (0.3-8.8%) as compared to a comparable tablet composition differing only in the use of magnesium stearate as a tableting lubricant.
- the presence of matrix with embedded Vitamin E at low concentrations (0-1.2%) did not show significant impact on disintegration times, however, increased the disintegration times from 0.9 to 2 and 4 min at higher concentrations (2.4% and 4.6%). It is well know in the art that for vitamin and mineral compositions addition magnesium stearate even at low concentrations (ca. 0.3%) usually increases disintegration times due to the hydrophobic nature it imparts on the compression blend.
- the matrix with embedded Vitamin E was also found to be compatible with other ingredients in vitamin and mineral tablets.
- the Vitamin E was fully recoverable and stable after compressed into tablets based on an accelerated stability study. No significant impacts of the Matrix with embedded Vitamin E were observed on the stability of other ingredients in vitamin and mineral tablets.
- a vitamin and mineral composition with 0.3% Magnesium stearate in place of the matrix with embedded Vitamin E but alike in all other respects was also prepared and compressed after mixed in the Littleford for 0, 2, 4, 10, and 20 minutes.
- Increasing the mixing time significantly reduced tablet hardness, slightly decreased ejection force, and significantly increased friability for tablets of using 0.3% magnesium stearate as a lubricant.
- Table 2 shows exemplary data for tablet hardness for tablets compressed at 40 kN after 0, 2, 4, 10 and 20 minutes of mixing.
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Priority Applications (38)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/787,381 US20080254119A1 (en) | 2007-04-16 | 2007-04-16 | Imbedded liquid lubricants for tableting |
MX2009011058A MX340643B (es) | 2007-04-16 | 2008-04-14 | Lubricantes liquidos embebidos para formacion de comprimidos. |
RU2009136554/13A RU2473243C2 (ru) | 2007-04-16 | 2008-04-14 | Жидкие смазки для таблетирования, интегрированные в таблетки |
HUE13154734A HUE038703T2 (hu) | 2007-04-16 | 2008-04-14 | Beágyazott folyékony kenõanyagok tablettázáshoz |
PH12009501979A PH12009501979A1 (en) | 2007-04-16 | 2008-04-14 | Embedded liquid lubricants for tableting |
DK13154734.1T DK2599394T3 (da) | 2007-04-16 | 2008-04-14 | Indlejrede flydende smøremidler til tablettering |
CN201510953380.5A CN105360879B (zh) | 2007-04-16 | 2008-04-14 | 用于压片的包埋液体润滑剂 |
RU2012138912A RU2615823C9 (ru) | 2007-04-16 | 2008-04-14 | Жидкие смазки для таблетирования, интегрированные в таблетки |
KR1020097023699A KR20100016514A (ko) | 2007-04-16 | 2008-04-14 | 타정용 매립 액체 윤활제 |
MYPI20094240A MY146906A (en) | 2007-04-16 | 2008-04-14 | Embedded liquid lubricants for tableting |
BRPI0810017-9A BRPI0810017A2 (pt) | 2007-04-16 | 2008-04-14 | Composição de suplemento nutricional, composição de multivitamina e mineral, composição farmacêutica, método e processo para preparar um tablete, e, tablete. |
KR1020157014285A KR101867139B1 (ko) | 2007-04-16 | 2008-04-14 | 타정용 매립 액체 윤활제 |
CN200880012059A CN101657109A (zh) | 2007-04-16 | 2008-04-14 | 用于压片的包埋液体润滑剂 |
ES08745723.0T ES2655552T3 (es) | 2007-04-16 | 2008-04-14 | Lubricantes líquidos incorporados para fabricación de comprimidos |
PL08745723T PL2136653T3 (pl) | 2007-04-16 | 2008-04-14 | Osadzone ciekłe środki smarujące do tabletkowania |
HUE08745723A HUE035179T2 (hu) | 2007-04-16 | 2008-04-14 | Beágyazott folyékony kenõanyagok tablettázáshoz |
DK08745723.0T DK2136653T3 (da) | 2007-04-16 | 2008-04-14 | Indlejrede flydende smøremidler til tablettering |
PT131547341T PT2599394T (pt) | 2007-04-16 | 2008-04-14 | Lubrificantes líquidos impregnados para produção de comprimidos |
AU2008242256A AU2008242256B2 (en) | 2007-04-16 | 2008-04-14 | Embedded liquid lubricants for tableting |
PT87457230T PT2136653T (pt) | 2007-04-16 | 2008-04-14 | Lubrificantes líquidos impregnados para produção de comprimidos |
NO08745723A NO2136653T3 (da) | 2007-04-16 | 2008-04-14 | |
CA2682551A CA2682551C (en) | 2007-04-16 | 2008-04-14 | Embedded liquid lubricants for tableting |
PL13154734T PL2599394T3 (pl) | 2007-04-16 | 2008-04-14 | Osadzone ciekłe środki smarujące do tabletkowania |
EP13154734.1A EP2599394B1 (en) | 2007-04-16 | 2008-04-14 | Embedded liquid lubricants for tableting |
JP2010504175A JP5615170B2 (ja) | 2007-04-16 | 2008-04-14 | 錠剤化用の埋め込まれた滑沢マトリクス |
PCT/US2008/060188 WO2008130883A1 (en) | 2007-04-16 | 2008-04-14 | Embedded liquid lubricants for tableting |
ES13154734.1T ES2676820T3 (es) | 2007-04-16 | 2008-04-14 | Lubricantes líquidos incorporados para fabricación de comprimidos |
NZ580136A NZ580136A (en) | 2007-04-16 | 2008-04-14 | Embedded liquid lubricants for tableting |
EP08745723.0A EP2136653B1 (en) | 2007-04-16 | 2008-04-14 | Embedded liquid lubricants for tableting |
TW097113859A TWI433652B (zh) | 2007-04-16 | 2008-04-16 | 用於壓錠之嵌入式液體潤滑劑 |
EC2009009676A ECSP099676A (es) | 2007-04-16 | 2009-10-02 | Lubricantes líquidos embebidos para formación de comprimidos |
IL201495A IL201495A (en) | 2007-04-16 | 2009-10-13 | Liquid lubricants embedded in a matrix for making tablets |
CO09114325A CO6220919A2 (es) | 2007-04-16 | 2009-10-14 | Lubricantes liquidos embebidos para formacion de comprimidos |
ZA2009/07217A ZA200907217B (en) | 2007-04-16 | 2009-10-15 | Embedded liquid lubricants for tableting |
JP2014113770A JP2014195459A (ja) | 2007-04-16 | 2014-06-02 | 錠剤化用の埋め込まれた滑沢マトリクス |
US14/449,335 US20140342047A1 (en) | 2007-04-16 | 2014-08-01 | Embedded Liquid Lubricants for Tableting |
HK16104223.3A HK1216227A1 (zh) | 2007-04-16 | 2016-04-13 | 用於壓片的包埋液體潤滑劑 |
US15/601,114 US11013251B2 (en) | 2007-04-16 | 2017-05-22 | Embedded liquid lubricants for tableting |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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US11/787,381 US20080254119A1 (en) | 2007-04-16 | 2007-04-16 | Imbedded liquid lubricants for tableting |
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Application Number | Title | Priority Date | Filing Date |
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US14/449,335 Continuation US20140342047A1 (en) | 2007-04-16 | 2014-08-01 | Embedded Liquid Lubricants for Tableting |
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US20080254119A1 true US20080254119A1 (en) | 2008-10-16 |
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Application Number | Title | Priority Date | Filing Date |
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US11/787,381 Abandoned US20080254119A1 (en) | 2007-04-16 | 2007-04-16 | Imbedded liquid lubricants for tableting |
US14/449,335 Abandoned US20140342047A1 (en) | 2007-04-16 | 2014-08-01 | Embedded Liquid Lubricants for Tableting |
US15/601,114 Active US11013251B2 (en) | 2007-04-16 | 2017-05-22 | Embedded liquid lubricants for tableting |
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Application Number | Title | Priority Date | Filing Date |
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US14/449,335 Abandoned US20140342047A1 (en) | 2007-04-16 | 2014-08-01 | Embedded Liquid Lubricants for Tableting |
US15/601,114 Active US11013251B2 (en) | 2007-04-16 | 2017-05-22 | Embedded liquid lubricants for tableting |
Country Status (26)
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---|---|
US (3) | US20080254119A1 (da) |
EP (2) | EP2136653B1 (da) |
JP (2) | JP5615170B2 (da) |
KR (2) | KR20100016514A (da) |
CN (2) | CN105360879B (da) |
AU (1) | AU2008242256B2 (da) |
BR (1) | BRPI0810017A2 (da) |
CA (1) | CA2682551C (da) |
CO (1) | CO6220919A2 (da) |
DK (2) | DK2136653T3 (da) |
EC (1) | ECSP099676A (da) |
ES (2) | ES2655552T3 (da) |
HK (1) | HK1216227A1 (da) |
HU (2) | HUE038703T2 (da) |
IL (1) | IL201495A (da) |
MX (1) | MX340643B (da) |
MY (1) | MY146906A (da) |
NO (1) | NO2136653T3 (da) |
NZ (1) | NZ580136A (da) |
PH (1) | PH12009501979A1 (da) |
PL (2) | PL2599394T3 (da) |
PT (2) | PT2599394T (da) |
RU (2) | RU2615823C9 (da) |
TW (1) | TWI433652B (da) |
WO (1) | WO2008130883A1 (da) |
ZA (1) | ZA200907217B (da) |
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20110223250A1 (en) * | 2004-03-29 | 2011-09-15 | Wyeth Llc | Multi-vitamin and mineral nutritional supplements |
WO2012079679A1 (en) * | 2010-12-16 | 2012-06-21 | Merck Patent Gmbh | Dry granulated cell culture media |
WO2012104075A3 (de) * | 2011-02-04 | 2012-10-18 | J. Rettenmaier & Söhne Gmbh + Co. Kg | Tablettierhilfsmittel |
WO2018019812A1 (en) | 2016-07-28 | 2018-02-01 | Merck Patent Gmbh | Process for improving the dissolution behaviour of components in aqueous solutions |
US20180235271A1 (en) * | 2017-02-21 | 2018-08-23 | Jarrow Formulas, Inc. | Probiotic dietary supplement formulation |
WO2019023250A1 (en) * | 2017-07-26 | 2019-01-31 | Abbott Laboratories | NUTRITIONAL TABLETS AND METHODS OF MAKING THE SAME |
US11419350B2 (en) | 2016-07-01 | 2022-08-23 | Corbion Biotech, Inc. | Feed ingredients comprising lysed microbial cells |
US11737987B2 (en) * | 2019-12-17 | 2023-08-29 | 9286-3620 Quebec Inc. | Oral delivery systems based on in situ forming protein/polysaccharide coacervates |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080254119A1 (en) * | 2007-04-16 | 2008-10-16 | Wyeth | Imbedded liquid lubricants for tableting |
KR102284453B1 (ko) * | 2014-01-29 | 2021-08-02 | 삼성전자 주식회사 | 셀룰러 이동 통신 시스템에서 상향링크 제어 정보 전송 방법 및 장치 |
SG11201705092TA (en) * | 2015-01-14 | 2017-07-28 | Pfizer | Oral delivery product |
JP2022543284A (ja) | 2019-08-08 | 2022-10-11 | エボニック オペレーションズ ゲーエムベーハー | 固形剤および潤滑剤の調製方法 |
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- 2008-04-14 RU RU2009136554/13A patent/RU2473243C2/ru active
- 2008-04-14 CN CN200880012059A patent/CN101657109A/zh active Pending
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- 2008-04-14 ES ES08745723.0T patent/ES2655552T3/es active Active
- 2008-04-14 PL PL13154734T patent/PL2599394T3/pl unknown
- 2008-04-14 WO PCT/US2008/060188 patent/WO2008130883A1/en active Application Filing
- 2008-04-14 NZ NZ580136A patent/NZ580136A/en unknown
- 2008-04-14 PT PT131547341T patent/PT2599394T/pt unknown
- 2008-04-14 AU AU2008242256A patent/AU2008242256B2/en active Active
- 2008-04-14 DK DK08745723.0T patent/DK2136653T3/da active
- 2008-04-14 EP EP08745723.0A patent/EP2136653B1/en active Active
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- 2008-04-14 PT PT87457230T patent/PT2136653T/pt unknown
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Cited By (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20110223250A1 (en) * | 2004-03-29 | 2011-09-15 | Wyeth Llc | Multi-vitamin and mineral nutritional supplements |
KR101899175B1 (ko) * | 2010-12-16 | 2018-09-14 | 메르크 파텐트 게엠베하 | 건조 과립화된 세포 배양 배지 |
WO2012079679A1 (en) * | 2010-12-16 | 2012-06-21 | Merck Patent Gmbh | Dry granulated cell culture media |
KR20140032370A (ko) * | 2010-12-16 | 2014-03-14 | 메르크 파텐트 게엠베하 | 건조 과립화된 세포 배양 배지 |
EP2652123B1 (en) | 2010-12-16 | 2016-01-13 | Merck Patent GmbH | Dry granulated cell culture media |
US9399757B2 (en) | 2010-12-16 | 2016-07-26 | Merck Patent Gmbh | Dry granulated cell culture media |
WO2012104075A3 (de) * | 2011-02-04 | 2012-10-18 | J. Rettenmaier & Söhne Gmbh + Co. Kg | Tablettierhilfsmittel |
US11419350B2 (en) | 2016-07-01 | 2022-08-23 | Corbion Biotech, Inc. | Feed ingredients comprising lysed microbial cells |
WO2018019812A1 (en) | 2016-07-28 | 2018-02-01 | Merck Patent Gmbh | Process for improving the dissolution behaviour of components in aqueous solutions |
US11019838B2 (en) * | 2017-02-21 | 2021-06-01 | Jarrow Formulas, Inc. | Probiotic dietary supplement formulation |
US20180235271A1 (en) * | 2017-02-21 | 2018-08-23 | Jarrow Formulas, Inc. | Probiotic dietary supplement formulation |
WO2019023250A1 (en) * | 2017-07-26 | 2019-01-31 | Abbott Laboratories | NUTRITIONAL TABLETS AND METHODS OF MAKING THE SAME |
US11737987B2 (en) * | 2019-12-17 | 2023-08-29 | 9286-3620 Quebec Inc. | Oral delivery systems based on in situ forming protein/polysaccharide coacervates |
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