Drug – bio-affecting and body treating compositions – Enzyme or coenzyme containing
Reexamination Certificate
1998-06-04
2002-12-31
Naff, David M. (Department: 1651)
Drug, bio-affecting and body treating compositions
Enzyme or coenzyme containing
C424S094300, C424S094600, C424S094610, C426S002000, C426S805000, C426S807000, C435S177000, C435S178000, C435S179000, C435S187000, C435S188000
Reexamination Certificate
active
06500426
ABSTRACT:
FILED OF THE INVENTION
The present invention relates to the formulation of enzymes, preferably feed-enzymes, into carbohydrate (e.g., starch-) containing granulates, and to processes for the preparation of such enzyme-containing granulates. These (edible) granulates can then be used in animal feeds.
BACKGROUND OF THE INVENTION
The use of various enzymes in animal, e.g., livestock, feed has become almost common practice. These enzymes are usually produced by culturing microorganisms in large. scale fermenters operated by industrial enzyme producers. At the end of the fermentation the resulting “broth” is usually subjected to a series of filtration steps to separate the biomass (the microorganisms) from the desired enzyme (in solution). The enzyme solution is either then sold as a liquid (often after addition of various stabilizers) or processed to a dry formulation.
Enzyme liquid and dry formulations are used on a commercial scale by the feed industry. Liquid formulations may be added to the feed after pelleting in order to avoid heat inactivation of the enzyme(s) which would occur during the pelleting process. However the amounts of enzyme in the final feed preparations are usually very small which makes it difficult to achieve a homogenous distribution of the enzyme in the feed, and liquids are notoriously more difficult to mix evenly than dry ingredients. In addition one needs specialised (expensive) equipment to add liquids to the feed after pelleting which is not currently available at most feed mills (due to the extra cost).
Dry formulations of enzyme(s), on the other hand, have the disadvantage of heat-inactivation of the enzymes during pelleting. Preferred manufacturing protocols in the feed industry involve steam pelleting where the feed is subjected to steam injection(s) prior to pelleting. In the subsequent pelleting step the feed is forced through a matrix or die and the resulting strips are cut into suitable pellets of variable length. The moisture content immediately before pelleting is generally between 18% and 19%. During this process temperatures may rise to 60-95° C. The combined effect of high moisture content and high temperature is detrimental to most enzymes. These disadvantages are also encountered in other types of thermomechanical treatments such as extrusion and expansion.
In order to try and overcome these problems EP-A-0,257,996 (Cultor Ltd.) suggests that the stability of enzymes in feed processing could be increased by the preparation of an enzyme “premix” where an enzyme-containing solution is absorbed onto a grain-based carrier consisting of flour, and the premix is subsequently pelleted and dried. However, these flour-based premixes are not suitable for gentler methods of processing (of the dough-like premix) into granulates, such as low-pressure extrusion or high shear granulation, because of the gluey character of the flour-based premixes.
Various enzyme manufacturers have developed alternative formulation methods to try to improve the stability of dry enzyme products during pelleting and storage.
EP-A-0,569,468 (Novo Nordisk) refers to a formulation consisting of a enzyme-containing “T-granulate” that is coated with a high melting wax or fat alleged to improve resistance to pelleting conditions. The granulate is prepared by mixing a dry inorganic (e.g., sodium sulphate) filler with the enzyme solution in a high shear granulator. EP-A-0,569,468 teaches that any beneficial effect of the coating with respect to pelleting stability is specific for the type of granulate coated, which in this case is based on a sodium sulphate filler. However, the absorption capacity of these (sodium sulphate) fillers is much less than that of carriers such as flour, which is undesirable if one wishes to produce more concentrated enzyme-containing granulates.
In addition, the granulates have a wide particle size distribution which makes it difficult to obtain a homogeneous enzyme concentration throughout. Moreover the bioavailability of the enzyme to the animal is decreased by the wax or fat coating.
WO-A-97/16076 (Novo Nordisk) also refers to the use of waxes and other water-insoluble substances in particulates, but here they are employed as a matrix material.
There is thus a need for stable formulations of enzymes that are based on a carrier that is suitable for granulation methods other than pelleting and that can have a high absorption capacity. Further objects and advantages of the invention will be apparent from the description herein.
BRIEF SUMMARY OF THE INVENTION
The present invention provides carbohydrate-based enzyme granulates and methods for the preparation of same. The granulates can be employed inter alia in animal feed compositions.
DETAILED DESCRIPTION OF THE INVENTION
In a first preferred aspect of the present invention there is provided a process for the preparation of an enzyme-containing granulate suitable for use in an animal feed, the process preferably comprising processing an enzyme, a solid carrier comprising at least about 15% (w/w) of an edible carbohydrate polymer, and water in appropriate relative amounts to obtain enzyme-containing granules, and subsequently drying the granules. The enzyme-containing granulate produceable by this process (which forms the second preferred aspect of the invention that preferably covers a granulate comprising dried granules formed from an enzyme and a solid carrier which comprises at least about 15% (w/w) of an edible carbohydrate polymer) seeks to solve or at least mitigates the problems encountered in the prior art.
The invention can thus preferably provide processes for the preparation of enzyme formulations in the form of granulates that use the carbohydrate as a carrier. The carrier desirably can be in particulate or powder form. The enzyme and water are preferably provided as an enzyme-containing (preferably aqueous) liquid, such as a solution or a slurry, which can be mixed with the solid carrier and allowed to absorb onto the carrier. During or after the mixing, the enzyme-containing liquid and the carrier are processed into a granulate, which optionally can then subsequently be dried. The use of the carbohydrate carrier can allow the absorption of large amounts of enzyme-containing liquid (and therefore enzyme). The mixture desirably can be used to form a plastic paste or non-elastic dough that can readily be processed into granules, for example it is extrudable. Suitably the carrier is non-fibrous which allows for easier granulation: fibrous materials can prevent granulation by extrusion.
A number of prior art documents refer to pellets containing various enzymes, but these find use as detergents, often in washing compositions. In contrast, the present invention finds use in animal feeds and, for that reason, the granulates of the invention are edible (by animals) and preferably also digestible. It therefore is a surprising and unexpected aspect of the present invention that the granulates, granules and compositions of the invention are free of soap, detergents and bleach or bleaching compounds, zeolites, binders, fillers (TiO
2
, kaolin, silicates, talc, etc.) to name but a few.
The edible carbohydrate polymer should be chosen so that it is edible by the animal for whom the feed is intended, and preferably is digestible as well. The polymer preferably comprises glucose (e.g., a glucose-containing polymer), or (C
6
H
10
5
)
n
, units. Preferably the carbohydrate polymer comprises &agr;-D-glucopyranose units, amylose (a linear (1→4) &agr;-D-glucan polymer) and/or amylopectin (a branched D-glucan with &agr;-D-(1→4) and &agr;-D-(1→6) linkages). Starch is the preferred carbohydrate polymer. Other suitable glucose-containing polymers that can be used instead of, or in addition to starch, include &agr;-glucans, &bgr;-glucans, pectin (such as proto-pectin), and glycogen. Derivatives of these carbohydrate polymers, such as ethers and/or esters thereof, are also contemplated although gelatinised starch is best avoided and thus may not be present. Suitably the carbohydrate polymer is wate
Barendse Rudolf Carolus Maria
Harz Hans-Peter
Meesters Gabriel Marinus Henricus
McDonnell & Boehnen Hulbert & Berghoff
Naff David M.
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