Process for manufacturing chewable dosage forms for drug delivery and products thereof

Abstract

A palatable, soft chewable medication vehicle for delivery of a pharmaceutically acceptable active ingredient, such as a drug, to an animal or human subject. The soft chews contain only food grade or better inactive ingredients, and preferably do not contain ingredients of animal origin. Processes for manufacturing the soft chews do not require the generation of heat during mixing of active and inactive ingredients, provide stable concentrations of the active ingredient, and produce chews of consistent weight and texture.

Description

FIELD OF THE INVENTION [0001] The invention relates to the field of orally administrable pharmaceutical dosage units; in particular, units in the form of an edible mass, such as a chunk. BACKGROUND OF THE INVENTION [0002] Formulation of a drug into an edible medication, such as a chewable tablet or confection, can increase patient acceptance of the medication, especially animals, who tend to resist swallowing hard tablets or capsules. Unfortunately, many drugs and other active ingredients (collectively, “actives”) have a strongly bitter or otherwise unpalatable taste, making chewing them unpleasant. [0003] Flavorings are commonly added to chewable medications to enhance their palatability. For example, a veterinary medication might include animal product-based flavorings such as uncooked dried meat parts such as beef, pork, chicken, turkey, fish and lamb; organ meats such as liver; meat meals, bone meals and ground bone; and animal-derived food such as casein, milk (which may includ...

AI Technical Summary

Benefits of technology

[0009] The invention provides a unique soft chew medication and processes for its manufacture. The soft chews of the invention are particularly palatable to pet animals. They contain inactive ingredients of at least food grade quality, and most preferably do not contain inactive ingredients of animal origin. As such, the soft chews may be manufactured without concern about transmission of infectious agents or contaminants, and without risk of cross-contaminating other products produced in the same manufacturing facility.

[0010] The manufacturing processes of the invention allow the soft chews to be produced without application of heat to the ingredient mixture. Stability of the actives is therefore preserved, and a well-blended, soft texture is provided. Further, no water is used as an ingredient of the chews, thereby avoiding the need for use of costly pharmaceutical grade water, while reducing the opportunity for microbial growth or loss of potency by the active.

[0011] To these ends, the soft chews of the invention are manufactured using large capacity horizontal mixers which spins the chew mixture into particulate form. The mixing action causes the ingredients in the mixture to be cast away from the mixing vessel walls, crisscrossing the vessel to provide a uniformly blended mixture formed without application of heat. Because no cooling step is required, the time to produce chews is shortened compared to cooking extrusion methods.

[0012] The highly blended mixture produced is placed into molds to form individual dosage units and allowed to set without application of heat. Soft chews can be produced in any desired shape. Preferred mixing and molding equipment utilized in the invention can provide individual soft chews with consistently blended ingredients, stably provided actives and consistent weights.

[0013] The soft chews of the invention are produced in palatable form without the use of any non-food grade inactive ingredients (or, preferably, any animal origin inactive ingredients). The manufacturing processes may therefore be performed without risk of potential cross-contamination of other equipment in the facility with infectious agents or contaminants derived from sources such as the animal-origin meat flavorings commonly used in chewable medications for animals.

Problems solved by technology

Unfortunately, many drugs and other active ingredients (collectively, “actives”) have a strongly bitter or otherwise unpalatable taste, making chewing them unpleasant.

However, use of many animal origin flavorings (especially of meat, poultry or seafood origin) risks exposure to infectious agents, not only to the recipient of the drug, but also through contamination of manufacturing equipment on which the flavored dosage units are made.

For this reason, manufacturing facilities that prepare pharmaceutical products with animal origin flavorings are often devoted exclusively to their preparation, at a correspondingly greater cost than would be incurred if manufacturing could be performed in a facility capable of concurrently processing multiple products.

Texture is also an issue for chewable medications.

One of the most commonly used form for chewable dosage units is the compressed tablet, whose ingredients (including the actives and inactive ingredients such as binders) can make the tablet gritty or otherwise unappealing, especially to animals.

The heat generated during the extrusion process can cause deterioration in the stability (potency or integrity) of the active in the mixture, causing the effective dose provided by each unit formed to vary.

Consistency of texture, shape and weights of the chews from batch to batch of extruded material can also suffer.