Method for enabling delivery of an active agent
First Claim
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1. An improvement to a method for enabling delivery of Tazarotene, the method comprising the steps of:
- manufacturing a fill formulation by dissolving Caprylic/Capric Triglyceride (CCT) butylated hydroxytoluene and hereafter dissolving the Tazarotene thereinto;
adding Polysorbate 80 and Sorbiton Monooleate to the CCT, butylated hydroxyanide, and Tazarotene to form a bulk solution;
mixing the bulk solution until homogeneous; and
encapsulating the homogeneous bulk solution into a capsule,said improvement comprising;
distributing educational materials to medical office personnel including prescribers who are qualified to prescribe the capsules for patients, said educational materials including information as to what the patients need to know and what the patients must do in order to both avoid adverse side effects while taking the capsules and to receive a prescription for the capsules; and
providing guidelines for counseling the patients with regard to what the patients need to know and what the patients must do in order to both avoid the adverse side effect while taking the capsules and to receive prescriptions for the capsules.
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Abstract
A method for enabling deliver of an active agent is provided which includes the preparation of doses of the active agent distributing educational materials and guidelines for counseling patients with regard to what the patients need to know and what the patients must do in order to both avoid adverse side effects while taking the dose and to receive prescriptions for the doses.
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Citations
25 Claims
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1. An improvement to a method for enabling delivery of Tazarotene, the method comprising the steps of:
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manufacturing a fill formulation by dissolving Caprylic/Capric Triglyceride (CCT) butylated hydroxytoluene and hereafter dissolving the Tazarotene thereinto; adding Polysorbate 80 and Sorbiton Monooleate to the CCT, butylated hydroxyanide, and Tazarotene to form a bulk solution; mixing the bulk solution until homogeneous; and encapsulating the homogeneous bulk solution into a capsule, said improvement comprising; distributing educational materials to medical office personnel including prescribers who are qualified to prescribe the capsules for patients, said educational materials including information as to what the patients need to know and what the patients must do in order to both avoid adverse side effects while taking the capsules and to receive a prescription for the capsules; and providing guidelines for counseling the patients with regard to what the patients need to know and what the patients must do in order to both avoid the adverse side effect while taking the capsules and to receive prescriptions for the capsules. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. An improvement to a method for enabling delivery of an active agent having low aqueous solubility, the method comprising the steps of:
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providing an active retinoid agent having low aqueous solubility consisting of Tazarotene; dissolving the active agent in a vehicle in order to eliminate initial active agent dissolution within a gastrointestinal tract; incorporating an emulsifier into the vehicle in order to promote subsequent self-emulsion of the active agent in a vehicle in the gastrointestinal tract; encapsulating an active agent, vehicle, and emulsifier with a capsule shell formulated to open upon ingestion into said gastrointestinal tract; and drying the capsule shell to obtain a selected hardness, said improvement comprising; distributing educational materials to prescribers who are qualified to prescribe the capsules for patients, said educational materials including information as to what the patients need to know and what the patients must do in order to both avoid adverse side effect while taking the capsules and to receive a prescription for the capsules; providing guidelines for counseling the patients with regard to what the patients need to know and what the patients must do in order to both avoid the adverse side effect while taking the capsules and to receive prescriptions for the capsules; requiring acknowledgment of receipt of the educational materials and guidelines; providing survey materials to the prescribers for distribution to the patients regarding what the patients need to know about the adverse side effect avoidance while taking the capsules and implementation by the patient of what the patient must do in order to avoid the adverse side effect while taking the capsules and to receive prescriptions for the capsules; receiving completed surveys from the patents; and advising the prescribers as continuance and discontinuance of prescribing capsules for the patients. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25)
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Specification