Method for enabling delivery of an active agent
First Claim
Patent Images
1. A method for enabling delivery of an active agent, said method comprising the steps of:
- preparing doses of the active agent by the steps of;
providing an active retinoid agent having low aqueous solubility;
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-emulsification of the active agent and vehicle in the gastrointestinal tract; and
encapsulating the active agent, vehicle and emulsifier with a capsule shell formulated to open upon ingestion into said gastrointestinal tract;
distributing educational materials to medical office personnel including prescribers who are qualified to prescribe the doses 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 doses and to receive a prescription for the doses; 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 dose and to receive prescriptions for the doses.
1 Assignment
0 Petitions
Accused Products
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.
-
Citations
48 Claims
-
1. A method for enabling delivery of an active agent, said method comprising the steps of:
-
preparing doses of the active agent by the steps of;
providing an active retinoid agent having low aqueous solubility;
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-emulsification of the active agent and vehicle in the gastrointestinal tract; and
encapsulating the active agent, vehicle and emulsifier with a capsule shell formulated to open upon ingestion into said gastrointestinal tract;
distributing educational materials to medical office personnel including prescribers who are qualified to prescribe the doses 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 doses and to receive a prescription for the doses; 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 dose and to receive prescriptions for the doses. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
-
-
28. A method for enabling delivery of an active agent, said method comprising the steps of:
-
preparing doses of the active agent by the steps of;
providing an active retinoid agent having low aqueous solubility;
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-emulsification of the active agent and vehicle in the gastrointestinal tract; and
encapsulating the active agent, vehicle and emulsifier with a capsule shell formulated to open upon ingestion into said gastrointestinal tract;
distributing educational materials to prescribers who are qualified to prescribe the doses 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 doses and to receive a prescription for the doses;
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 dose and to receive prescriptions for the doses;
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 doses and implementation by the patient of what the patient must do in order to avoid the adverse side effect while taking the doses and to receive prescriptions for the doses;
receiving completed surveys from the patents; and
advising the prescribers as continuance and discontinuance of prescribing doses for the patients. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48)
-
Specification