Delivery of Hypericum perforatum (St. John's Wort) in...

Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from hypericum

Reexamination Certificate

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Details

C424S451000, C424S452000, C424S463000, C424S464000, C424S725000, C514S960000

Reexamination Certificate

active

06607754

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the delivery of St. John's Wort (
Hypericum perforatum
, active ingredient hypericin) in tablet form in increased dosimetric volumes at decreased frequency of administration.
2. Background of the Art
The use of naturally occurring organic materials for dietary supplements as well as for specific medical treatments has increased dramatically over the past decades. Significant medical treatments have resulted from investigation of herblore and folklore treatment with common plants. Commercially, the plants have been treated for consumption and provided in powder or tablet format for the public. As with conventional delivery of medicines, the supplements must be delivered in sufficient quantity to have their desired effect, have the delivery spread out over the course of the day rather than spiked at a single intake (especially if the supplement can not be stored by the body), and yet have the likelihood of compliance by the patient with the recommended dosage. These requirements may often be in conflict with each other, with increased frequency of delivery competing against the likelihood of dosage compliance by the patient, for example.
Not all supplements are compatible with some of the drug delivery means available to provide effective administration of the drugs or supplements. For example, some materials cannot be delivered transcutaneously because of their molecular size or oleophilicity, some materials cannot be effectively administered orally, some drugs are not stable in tablet form, and therefore each supplement or drug must be considered independently.
BRIEF DESCRIPTION OF THE INVENTION
The active ingredient of St. John's Wort (
Hypericum perforatum
, hypericin) has been found to be deliverable by tablet format in administered levels sufficient to allow b.i.d. (twice a day) supplements to a person. The size of a full tablet is within patient acceptable size range, and the use of timed release ingredients within the tablet allow for the b.i.d. supplement to provide acceptable levels of the hypericin over the course of the day. This increases the likelihood of compliance with daily administration levels without the person attempting to catch up to supplement requirements with a double administration.


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The National Gardening Association Dictionary Of Horticulture, The Philip Lief Group, Inc., Penguin Books, NY, NY pp. 230-231, 1996.*
Remington's Pharmaceutical Sciences, 16th Edition, Mack Publishing Co., Easton, PA, pp. 1553-1566, 1980.*
“Oral Solid Dosage Forms”,In: Remington's Pharmaceutical Sciences, Chapter 90, 17th Edition, A.R. Gennaro et al., eds., Mack Publishing Co., Easton, PA, 1610-1614, (1985).
Lachman, L., et al., “Tablets”,In: The Theory and Practice of Industrial Pharmacy, 3rd Edition, Lea & Febiger, Philadelphia, PA, 318-320, (1986).
Miller, S., “A Natural Mood Booster”,Newsweek, 74-75, (May 5, 1997).
Tyler, V.E., “The Herbal Remedies Market, St. John's Wort”,Chemtech, 56-57, (May 1997).

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