Variable-Dose Packaging System

Abstract

The invention relates to a packages and kits for dispensing and/or administering pharmaceuticals, particularly for dispensing and/or administering combinations of different formulations.

1 - 106 . (canceled) 
   
   
       107 . A package for providing a customized dose of a variable-dose therapeutic regimen, comprising
 (a) at least one subunit A comprising a plurality of interconnected unit dosage forms of formulation A;   (b) at least one subunit B comprising a plurality of interconnected unit dosage forms of formulation B; and   (c) means to physically associate at least one subunit A to at least one subunit B; wherein formulation A and formulation B each comprise an active ingredient X, and the amount of active ingredient X in a unit dosage form of formulation A is not equal to the amount of active ingredient X in a unit dosage form of formulation B, and a dose comprises one unit dosage form from each subunit, and the dose is customized for a patient by adding or removing subunits A or B to or from the package.   
   
   
       108 . The package of  claim 107 , wherein at least one of the unit dosage forms is enclosed in a rupturable cell. 
   
   
       109 . The package of  claim 107 , wherein at least one subunit comprises fewer unit dosage forms than another subunit. 
   
   
       110 . The package of  claim 107 , wherein each subunit includes an equal number of unit dosage forms. 
   
   
       111 . The package of  claim 107 , wherein the unit dosage forms of formulation A and unit dosage forms of formulation B together are associated in a grid pattern such that each row is a dose and each column is a subunit. 
   
   
       112 . The package of  claim 107 , wherein the means to physically associate a subunit A with a subunit B comprises positioning means. 
   
   
       113 . The package of  claim 112 , wherein the positioning means is partially filled with a predefined set of subunits A or B. 
   
   
       114 . The package of  claim 107 , wherein the means to physically associate a subunit A with a subunit B comprises appendages on subunit A that are adapted to be put through receptacles of a subunit B. 
   
   
       115 . The package of  claim 107 , wherein the means to physically associate a subunit A with a subunit B comprises an adhesive on a subunit A that is adapted to adhere to a subunit B. 
   
   
       116 . The package of  claim 107 , wherein each dose is independently removable from the package. 
   
   
       117 . The package of  claim 107 , wherein the subunits A and/or B are provided with pre-formed interconnections. 
   
   
       118 . The package of  claim 117 , wherein the subunits A and/or B are provided on a roll, a sheet, concentric rings, strips, or another pre-formed interconnection. 
   
   
       119 . The package of  claim 107 , wherein said subunits A and/or B comprise a number of unit dosage forms appropriate for the therapeutic regimen, or is adapted to partition such appropriate number of unit dosage forms from a larger number of interconnected unit dosage forms. 
   
   
       120 . The package of  claim 119 , wherein said larger number of interconnected unit dosage forms is adapted to aid the partition of a subunit comprising an appropriate number of unit dosage forms. 
   
   
       121 . The package of  claim 107 , wherein said means provides for a plurality of subunits A or B to be added to a template so as to create the customized dose or an appropriate number of customized doses. 
   
   
       122 . The package of  claim 107 , wherein said means provides for a plurality of subunits A or B to be removed from a template, so as to create the customized dose or an appropriate number of customized doses. 
   
   
       123 . The package of  claim 121 , wherein said template comprises a predefined set of unit dosage forms of formulation A or B. 
   
   
       124 . The package of  claim 107 , wherein said package comprises instructions to interconnect an appropriate number of unit dosage forms of formulation A or B for a patient, so as to create a patient-customized dose of the therapeutic regimen. 
   
   
       125 . The package of  claim 107 , wherein said package comprises instructions to physically associate an appropriate number of subunits A with subunits B so as to create the customized dose. 
   
   
       126 . The package of  claim 107 , wherein at least one subunit A is physically associated with at least one subunit B. 
   
   
       127 . The package of  claim 107 , further comprising instructions for a patient to consume a unit dosage form from each of subunits A and B of the package at predetermined intervals or times. 
   
   
       128 . The package of  claim 107 , wherein formulation A and formulation B have different pharmacological or pharmacokinetic properties. 
   
   
       129 . The package of  claim 128 , wherein formulation A is a sustained release formulation and formulation B is a rapid release formulation. 
   
   
       130 . The package of  claim 107 , wherein a unit dosage form of formulation A comprises an amount of active ingredient X that is greater than the amount of active ingredient X in a unit dosage form of formulation B by a factor of about 2, about 4, about 5, about 10, about 25, or about 50. 
   
   
       131 . The package of  claim 107 , wherein the active ingredient X is selected from a cytotoxic compound, a chemotherapeutic compound, a high potency compound, and an orally available platinum complex. 
   
   
       132 . The package of  claim 107 , wherein at least one of the unit dosage forms of at least one of formulations A or B are adapted for oral administration. 
   
   
       133 . The package of  claim 132 , wherein the unit dosage form suitable for oral administration is selected from tablets, pills, capsules, or gelcaps. 
   
   
       134 . The package of  claim 107 , wherein the active ingredient X is satraplatin, or a metabolite or a prodrug thereof. 
   
   
       135 . The package of  claim 134 , wherein said package provides a customized dose of satraplatin. 
   
   
       136 . The package of  claim 134 , wherein a unit dosage form of formulation A comprises an amount of satraplatin selected from about 75 mg, about 50 mg, about 25 mg, about 10 mg, and about 5 mg. 
   
   
       137 . The package of  claim 134 , wherein a unit dosage form of formulation A comprises about 50 mg of satraplatin and a unit dosage form of formulation B comprises about 10 mg of satraplatin. 
   
   
       138 . The package of  claim 107 , wherein the number of doses is selected from between 3 and 35, about 14, about 10, about 7, and about 5. 
   
   
       139 . The package of  claim 107 , wherein each dose is designated with a day of the week or month. 
   
   
       140 . The package of  claim 107 , further comprising a plurality of unit dosage forms of formulation C, wherein formulation C is different from formulations A and B. 
   
   
       141 . The package of  claim 140 , wherein said formulation C comprises an active ingredient selected from a cytotoxic compound, a chemotherapeutic compound, an orally available platinum complex, a radiosensitizer, an anti-emetic, an anti-diarrheal, a high potency compound, a compound with a narrow therapeutic index, and a hormonal anti-cancer agent. 
   
   
       142 . A package for providing a customized dose of satraplatin, said package comprising:
 (a) at least one subunit A comprising a plurality of interconnected unit dosage forms of formulation A, formulation A comprising an amount of satraplatin;   (b) at least one subunit B comprising a plurality of interconnected unit dosage forms of formulation B, formulation B comprising an amount of satraplatin that is not equal to the amount in a unit dosage form of formulation A;   
     such that a dose comprises one unit dosage form from each subunit, and the dose is customized for a patient by adding or removing subunits A or B. 
   
   
       143 . The package of  claim 136 , wherein a unit dosage form of formulation A comprises an amount of satraplatin selected from about 75 mg, about 50 mg, about 25 mg, about 10 mg, and about 5 mg. 
   
   
       144 . The package of  claim 136 , wherein a unit dosage form of formulation A comprises an amount of satraplatin that is greater than the amount in a unit dosage form of formulation B by a factor of about 2, about 4, about 5, about 10, about 25, and about 50. 
   
   
       145 . The package of  claim 142 , further adapted for a consistent dose over an administration cycle selected from between 3 and 35 days, about 14 days, about 10 days, about 7 days, and about 5 days. 
   
   
       146 . Use of the package of  claim 107  in a variable-dose therapeutic regimen for the treatment of a patient suffering from a disease. 
   
   
       147 . The use of  claim 146 , wherein the disease is selected from cancer, hypertension, hypothyroidism, heart-related ailments, and depression. 
   
   
       148 . The use of  claim 147 , wherein the disease is a cancer selected from liver, stomach, colon, breast, pancreatic, skin, cervical, ovarian, testicular, lung, and head and neck, prostate, hormone resistant prostate, small cell lung, and metastasises thereof. 
   
   
       149 . A kit for assembling or preparing a customized dosage of a variable-dose therapeutic regimen, comprising:
 (a) at least one subunit A comprising a plurality of unit dosage forms of formulation A;   (b) at least one subunit B comprising a plurality of unit dosage forms of formulation B; and   (c) means to interconnect or physically associate the unit dosage forms of formulation A in a subunit A or the unit dosage forms of formulation B in a subunit B; wherein said customized dose is provided in a package of  claim 107  or  142 .   
   
   
       150 . A method for assembling or preparing a package of  claim 107 , comprising determining the appropriate number of unit dosage forms of formulations A and B to achieve a prescribed dose of a variable-dose therapeutic regimen, and
 (a) adding to or removing subunits from the package, or   (b) using the kit of  claim 149 , thereby customizing the dose for a patient.   
   
   
       151 . A method for treating a patient suffering from a disease comprising:
 (a) determining for said patient the appropriate dose of a variable-dose therapeutic regimen;   (b) prescribing for said patient a customized dose of a variable-dose therapeutic regimen in a package of  claim 107  or  142 ; and   (c) instructing said patient to consume a unit dosage form from each of subunits A and B of the package at predetermined intervals.   
   
   
       152 . The method of  claim 151 , further comprising:
 instructing said patient to consume a unit dosage form of formulation C at predetermined intervals, wherein formulation C is different from formulations A and B.   
   
   
       153 . The method of  claim 151 , wherein the disease is selected from cancer, hypertension, hypothyroidism, heart-related ailments, and depression. 
   
   
       154 . The method of  claim 151 , wherein the disease is a cancer selected from liver, stomach, colon, breast, pancreatic, skin, cervical, ovarian, testicular, lung, and head and neck, prostate, hormone resistant prostate, small cell lung, and metastasises thereof.