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System and process for providing at least one opening in dosage formsSystem and process for providing at least one opening in dosage forms description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20090148523, System and process for providing at least one opening in dosage forms. Brief Patent Description - Full Patent Description - Patent Application Claims
The present invention relates to apparatus, methods, and processes for making solid dosage forms comprising at least one active ingredient, a core and shell configuration, wherein the shell comprises a hardenable material, such as a thermal-gelling polymer, for example gelatin; and the shell is provided with at least one opening. The opening(s) are formed while the shell is still in a softened state. A variety of dosage forms, such as tablets, capsules and gelcaps are known in the pharmaceutical arts. Tablets generally refer to relatively compressed powders in various shapes. One type of elongated, capsule-shaped tablet is commonly referred to as a “caplet.” Capsules are typically manufactured using a two piece gelatin shell formed by dipping a steel rod into gelatin so that the gelatin coats the end of the rod. The gelatin is hardened into two half-shells and the rod extracted. The hardened half-shells are then filled with a powder and the two halves joined together to form the capsule. Dosage forms having core and shell portions are well-known. Outer shell portions are provided over active cores for many reasons. The shell can, for example, provide taste-masking of bitter actives, modify the dissolution profile, delay the delivery thereof, or provide means for identifying the sources of goods. Gelatin-coated tablets, commonly known as geltabs and gelcaps, are an improvement on gelatin capsules and typically comprise a tablet coated with a gelatin shell. Several well known examples of gelcaps are McNeil Consumer Healthcare\'s acetaminophen based products sold under the trade name Tylenol®. U.S. Pat. Nos. 4,820,524; 5,538,125; 5,228,916; 5,436,026; 5,679,406; 5,415,868; 5,824,338; 5,089,270; 5,213,738; 5,464,631; 5,795,588; 5,511,361; 5,609,010; 5,200,191; 5,459,983; 5,146,730; 5,942,034 describe geltabs and gelcaps and methods and apparatuses for making them. Conventional methods for forming gelcaps are generally performed in a batchwise manner using a number of stand alone machines operating independently. Such batch processes typically include the unit operations of granulating, drying, blending, compacting (e.g., in a tablet press), gelatin dipping or enrobing, drying, and printing. Another method of producing gelatin coated dosage forms is via an enrobing process wherein two separate films made of gelatinous material are applied to opposite sides of a tablet by a pair of rotary dies, as disclosed for example, in U.S. Pat. Nos. 5,146,730 and 5,459,983. Film formulations for producing gelcaps and geltabs prepared via enrobing methods such as those disclosed in U.S. Pat. Nos. 5,146,730 and 5,459,983 typically comprise a water-based gelatin preparation having about 45% gelatin and about 9% plasticizer (glycerin and/or sorbitol) by weight. Glycerin and sorbitol can be used as single plasticizers or in combination with each other. In addition, other sugars and poly-hydroxy compounds can be used as additives and plasticizers. If a tamper-evident gelatin-coated medicine tablet is the desired end product, then the ratio of plasticizer to gelatin in the gelatin formulation should be in the range of about 1:5. Certain dosage forms containing apertures or embossments are known. For instance, “osmotic pump” dosage forms for the administration of pharmaceutically active ingredients are known in the art. They typically comprise a semipermeable wall that surrounds a reservoir containing drug. The wall is permeable to the passage of an external fluid, impermeable to the passage of drug, and has a passageway through the semipermeable wall for delivering drug from the osmotic system. For example, U.S. Pat. No. 4,576,604 discloses an osmotic device comprising a drug compartment surrounded by a wall (coating) having a passageway therein. The wall may comprise an immediate release dose of drug, and the inner drug compartment may comprise a sustained release dose of drug. U.S. Pat. No. 4,449,983 discloses another osmotic device comprising two separately housed drugs that are separately dispensed from the device. The device comprises two compartments, one for each drug, separated by a partition. Each compartment has an orifice for communicating with the exterior of the device. U.S. Pat. No. 3,823,816 discloses a water-soluble package provided in the form of a hard shell capsule filled with powder, granules, or the like. The capsule is apertured, and a water-soluble barrier film covers the apertures. The film is more water soluble than the capsule so that when the package contacts water, the film rather than the capsule dissolves first, exposing the contents for dissolution and/or release by way of the apertures while the capsule is intact. U.S. Pat. No. 5,256,440 relates to an intagliated dosage form comprising one or more circumscribed regions on its surface. The dosage form is spray coated with a latex polymer. When placed in an environment of use, the latex coating within the circumscribed region is reproducibly expelled, leaving a coated core tablet with a predefined aperture, which exposes a discrete portion of the core surface to the environment of use. The present invention is directed to a system for manufacturing one or more dosage forms having a core and a shell that surrounds at least a portion of the core and having one or more openings. The system comprises a shell-forming module that overcoats at least a portion of the core with a soft shell, a post-coating transfer module for conveying a soft dosage form from the shell-forming module, and a punch assembly for producing at least one opening in the soft shell. The system can further comprise a hardening module for substantially solidifying the shell. The hardening module can employ a drying module for substantially eliminating moisture from the shell. The post-coating transfer module can include a substrate velocity modifying means that enables a controlled transfer of individual substrates between two unit operations that convey individual substrates at different velocities. The post-coating transfer module can be characterized by having a first dosage form conveyor from the shell-forming module, a substrate velocity modifying means for modifying the velocity of dosage forms received from the first dosage form conveyor and a second dosage form conveyor from the substrate velocity modifying means. A transfer arm can move dosage forms from the second conveyor to a third conveyor into a dryer unit. The substrate velocity modifying means can be characterized as having a rotating turret with a plurality of slats for holding individual dosage form carriers. Each slat preferably comprises two carrier tubes. The carrier tubes can move from the outer periphery of the rotating turret towards the center of the rotating turret. Alternatively, the carrier tubes move closer to one another in a radial direction. The soft shell dosage form preferably has a water-content at least 20% greater than its moisture content at equilibrium at 25° C. and 60% relative humidity. The shell can contain one or more gelatin or gelling materials. The average thickness of the shell, excluding uncoated or exposed areas of the core, is preferably in the range from about 100 to about 400 microns. The core comprises at least one active ingredient that can be provided for immediate release. The core can be in the form of a compressed tablet, preferably having a hardness from about 1 to about 30 kp/cm2. One or more openings can be provided into or through the shell, each opening can be from about 200 to about 2000 microns in diameter (if circular) or provide similar a similar opening area regardless of the shape of the opening. The post-coating transfer module can convey a soft dosage form from the shell-forming module to the punch assembly for producing at least one opening in the soft shell. The punch assembly can be located along the path of the first dosage form conveyor, adjacent to the means for modifying dosage form velocity, along the path of the second conveyor or along the path of the third conveyor. The present invention is also directed to a process for making a dosage form having a core and a shell that surrounds at least a portion of the core and having one or more openings. The process comprises providing a shell over at least a portion of the compressed core and providing at least one opening in said shell, wherein the shell is soft at the time the opening is provided in said shell. One or more openings through the shell can contact the core. The soft shell preferably has, at a point in time immediately before one or more openings are provided therein, a water-content at least 20% greater than its moisture content at equilibrium at 25° C. and 60% relative humidity. The present invention is particularly advantageous for providing openings through outer coatings comprising gelatin. Dry gelatin, such as that in hard gelatin capsule shells or finished gelcap coatings cannot be ablated using lasers due to scorching. Forming openings by punching while the gelatin is still in a hydrated (soft and deformable) state allows for both an easier punch through and some smoothing of the edges of the punched opening due to cold flow. Continue reading about System and process for providing at least one opening in dosage forms... Full patent description for System and process for providing at least one opening in dosage forms Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this System and process for providing at least one opening in dosage forms patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. Start now! - Receive info on patent apps like System and process for providing at least one opening in dosage forms or other areas of interest. ### Previous Patent Application: Heated roller compaction process for making pharmaceutical compositions Next Patent Application: Method of producing solid preparation disintegrating in the oral cavity Industry Class: Drug, bio-affecting and body treating compositions ### FreshPatents.com Support Thank you for viewing the System and process for providing at least one opening in dosage forms patent info. IP-related news and info Results in 2.01255 seconds Other interesting Feshpatents.com categories: Software: Finance , AI , Databases , Development , Document , Navigation , Error paws |
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