US 2016/0101194 A1 · SMART® Medication Adherence Formulation, Method, Device and System for Topical, Vaginal or Rectal Routes of Administration

Abstract

Novel compositions, methods, systems and devices are disclosed which contain markers for definitive medication adherence monitoring for Active Pharmaceutical Ingredients (APIs) delivered topically, vaginally or rectally. This invention is useful in a wide range of contexts, including, but not limited to, clinical trial settings, home use settings, or other settings, where it is necessary to definitively confirm that a given patient has taken or been administered a given medication at the correct time and in the correct dosage via a topical, vaginal or rectal route of delivery. Specific formulations of markers are disclosed for inclusion in compositions for Active Pharmaceutical Ingredient (API) delivery, including but not limited to delivery of microbicidally active compounds such that on topical, vaginal or rectal delivery, said AEM is detected in the breath or an Exhaled Drug Emplacement Marker, EDEM, which is a metabolite of the AEM, is detected in the breath.

Claims15

Dependent claims

A topical, vaginal or rectal composition adapted for medication adherence monitoring, comprising:

(a) at least one Adherence Enabling Marker (AEM) which, when delivered topically, vaginally or rectally produces an Exhaled Drug Emplacement Marker (EDEM) which is the AEM itself or a metabolite thereof detectable in the exhaled breath;
(b) a vehicle for topical, vaginal or rectal delivery of an Active Pharmaceutical Ingredient (API) active compound;
and
(c) an API.

1 more element

A method for definitive monitoring of medication adherence, wherein said medication is adapted for topical, vaginal or rectal administration, comprising:

(A) providing to a subject a medication comprising
(i) at least one API which is microbicidally active compound, an API selected from a peptide and a protein, an API which is a small organic molecule (molecular weight <900-1200 daltons), an API which is a DNA/RNA-based therapeutic such as an aptamer, and an API which is a small organic molecule (molecular weight <900-1200 daltons);
(ii) an Adherence Enabling Marker (AEM) composition, wherein said AEM composition is selected from the group consisting of at least one of:
(a) a low molecular non-toxic compound;
(b) a secondary or tertiary alcohol with between three and eight carbon atoms;
(c) a peptide;
(d) a protein;
(e) a DNA or RNA molecule;
which AEM when delivered topically, vaginally or rectally produces an Exhaled Drug Emplacement Marker (EDEM) detectable in the exhaled breath;
and
(iii) a vehicle for topical, vaginal or rectal delivery of a microbicidally active compound;
and
(B) measuring the exhaled breath of the subject with a SMART® device, which accurately measures the EDEM and optionally provides medication reminder functions, and orchestrates critical adherence information flow between relevant stakeholders.

10 more elements

Dependencies are inferred from the claim text.

SMART® Medication Adherence Formulation, Method, Device and System for Topical, Vaginal or Rectal Routes of Administration

Life of this patent

SMART® Medication Adherence Formulation, Method, Device and System for Topical, Vaginal or Rectal Routes of Administration

Life of this patent

Abstract

Claims15