Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
2000-03-24
2001-09-11
Dodson, Shelley A. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S451000, C424S464000, C424S468000
Reexamination Certificate
active
06287595
ABSTRACT:
CROSS REFERENCE TO RELATED CASES
The following U.S. patents are of interest: U.S. Pat. No. 5,669,973 issued Sep. 23, 1997 to Pletcher et al., APPARATUS FOR ELECTROSTATICALLY DEPOSITING AND RETAINING MATERIALS UPON A SUBSTRATE; U.S. Pat. No. 5,714,007 issued Feb. 03, 1998 to Pletcher et al., APPARATUS FOR ELECTROSTATICALLY DEPOSITING A MEDICAMENT POWDER UPON PREDEFINED REGIONS OF A SUBSTRATE; U.S. Pat. No. 5,788,814 issued Aug. 04,1998 to Sun, CHUCKS AND METHODS FOR POSITIONING MULTIPLE OBJECTS ONA SUBSTRATE; U.S. Pat. No. 5,753,302 issued May 19, 1998 to Sun et al., ACOUSTIC DISPENSER; U.S. Pat. No. 5,846,595 issued Dec. 08, 1998 to Sun et al., ELECTROSTATIC CHUCKS; U.S. Pat. No. 5,858,814 issued Jan. 12, 1999 to Sun et al., ELECTROSTATIC CHUCKS; U.S. Pat. No. 5,871,010 issued Feb. 16, 1999 to Datta et al., INHALER APPARATUS WITH MODIFIED SURFACES FOR ENHANCED RELEASE OF DRY POWDERS; U.S. Pat. No. 6,007,630 issued Dec. 28, 1999 to Pletcher et al., METHOD AND APPARATUS FOR ELECTROSTATICALLY DEPOSITING A MEDICAMENT POWDER UPON PREDEFINED REGIONS OF A SUBSTRATE; U.S. Pat. No. 6,074,688 issued Jun. 13, 2000 to Pletcher et al., METHOD AND APPARATUS FOR ELECTROSTATICALLY DEPOSITING A MEDICAMENT POWDER UPON PREDEFINED REGIONS OF A SUBSTRATE; U.S. Pat. No. 6,004,752 issued Dec. 21, 1999 to Loewy et al., DEPOSITED REAGENTS FOR CHEMICAL PROCESSES; U.S. Pat. No. 6,045,753 issued Apr. 04, 2000 to Loewy et al., SOLID SUPPORT WITH ATTACHED MOLECULES; U.S. Pat. No.6,096,368 issued Aug. 01, 2000 to Sun, BEAD TRANSPORTER CHUCKS USING REPULSIVE FIELD GUIDANCE; U.S. Pat. No. 5,988,432 issued Nov. 23, 1999 to Sun, BEAD MANIPULATING CHUCKS WITH BEAD SIZE SELECTOR; U.S. Pat. No. 6,168,666 issued Jan. 01, 2001 to Sun, FOCUSED ACOUSTIC BEAD CHARGER/DISPENSER FOR BEAD MANIPULATING CHUCKS; U.S. Pat. No. 6,149,774 issued Nov. 21, 2000 to Sun et al., AC WAVEFORMS BIASING FOR BEAD MANIPULATING CHUCKS; and U.S. Pat. No. 6,063,194 issued May 16 2000 to Desai et al., DRY POWDER DEPOSITION APPARATUS.
The following U.S. patent applications are of interest: Ser. No. 09/095,321 filed Jun. 10, 1998 by Sun et al., APPARATUS FOR CLAMPING A PLANAR SUBSTRATE and Ser. No. 09/095,616 filed Jun. 10, 1998 by Chrai et al., PHARMACEUTICAL PRODUCT.
FIELD OF THE INVENTION
The present invention relates generally to unit dosage or unit diagnostic forms and an apparatus and method for making such unit forms.
BACKGROUND OF THE INVENTION
In the pharmaceutical industry, pharmaceutical products including diagnostic products comprise a container (e.g., a bottle, a blister pack or other packaging) containing a plurality of “unit dosage forms” or “unit diagnostic forms.” Each of such unit forms contains a pharmaceutically- or biologically-active ingredient or ingredients and inert or inactive ingredient(s).
The pharmaceutically-active ingredient typically forms a drug. The diagnostic form may comprise a reagent or the like for use in diagnostic tests, and may be part of a set which includes several different reagents or active ingredients. Moreover, the diagnostic form may comprise an antibody, an antigen, or labeled forms thereof and the like.
A pharmaceutically- or biologically-active ingredient for use in a unit form may be supplied as a powder comprising a plurality of active-ingredient particles. Such active-ingredient particles are combined with inert or inactive ingredient particles to form a plurality of “major particles.” The major particles are quite small, with dimensions on the order of microns. Such major particles are typically combined with one another to create the final unit dosage or diagnostic form (e.g., tablet, caplet, test strip, capsule, etc.).
There may be significant variation in the amount of pharmaceutically- or biologically-active ingredient in one major particle and the next. Since a large number of major particles are required to create a final unit form, the aforedescribed particle-to-particle variation may result in a substantial variation in the amount of active ingredient between one unit form and the next. Thus, any given final form may contain substantially more or less than a desired amount of active ingredients.
Destructive analytical screening procedures are conventionally performed to assess the amount of active ingredient(s) in final unit forms. Since such procedures destroy the unit forms, a statistical sampling is performed whereby a relatively small number of forms per batch are actually sampled and tested. Such screening procedures disadvantageously provide no assurance that all forms in a given batch contain a desired amount of the pharmaceutically- or biologically-active ingredients. In fact, such statistical methods practically “guarantee” that a statistically determinable percentage of the forms in each batch will be out of specification.
As such, the art would benefit from a method and apparatus that provides improved control over the active-ingredient content of unit dosage and diagnostic forms.
SUMMARY OF THE INVENTION
In one embodiment, the present invention provides a product comprising a plurality of pharmaceutical unit dosage forms or unit diagnostic forms (collectively, “unit forms”). Each form includes at least one active ingredient that is present in an amount that advantageously does not vary by more than about five percent from a predetermined target amount.
In one embodiment, the unit form comprises a substrate, an active ingredient deposited thereon, and a cover layer that covers the active ingredient and is joined (e.g., via welding, adhesives, etc.) to the substrate in the proximity of the active ingredient.
In the illustrated embodiments, the product is made via a dry deposition apparatus that deposits powder/grains on the substrate. In one embodiment, the apparatus comprises an electrostatic chuck, a charged powder delivery apparatus, and an optical detection system. The substrate is engaged to the electrostatic chuck for the dry deposition of powder. The chuck has at least one collection zone at which a powder-attracting electrical field is developed. The charged powder-delivery apparatus directs charged powder for electrostatic deposition to the substrate at the collection zone(s). The optical detection system quantifies the amount of powder deposited.
In some embodiments, the dry deposition apparatus also includes an electronic processor for controlling depositions responsive to sensor inputs. Such sensor inputs advantageously include one or more deposition sensors that are disposed on or adjacent to the electrostatic chuck and that provide data pertaining to the amount of powder deposited. Responsive to sensor data, the electronic processor adjusts deposition parameters, as necessary. Controllable parameters include powder flux through the powder-delivery apparatus and applied voltage at the collection zone(s).
In still other embodiments, the present dry deposition apparatus advantageously includes a variety of other elements that are described in detail later in this Specification.
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Loewy Zvi
Matthies Dennis Lee
Carella Byrne Bain GilfillanCecchi
Delsys Pharmaceuticals Corporation
Dodson Shelley A.
Olstein Elliot M.
Squire William
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