ZA200506705B - Kit for pharmaceutical use - Google Patents

Description

KIT FOR PHARMACEUTICAL USE

FIELD OF THE INV ENTION

The present invention relates to Kits for the prharmaceutical administration of an active ingredient and one or morc accompanying nutrients . These kits are particularly useful for treatment regimens wherein the active ingredient is adrministered on a continuous frequency other than daily and the nutrient is administered on the days in between the days the active ingredient is administered.

BACKGROUND OF THE: INVENTION

With many treatment regimens, to achieve ma=imum efficiency of the active ingredients it is advisable to supplement the regimen with one or rmiore nutrients. Therefore, the patient must remember not onty to take the active ingredient, but allso the associated nutrient. These dosages may require administration at different times of thee day or under different conditions, for example, on an empty stomach vs. a full stomach. In addition, when the pharmaceutical active is not administered cvery day, remembering which day the active is to be taken can be confusing to (he patient. Patient compliance with these types of programs is therefore an issue.

Many types of kits have been developed for dispensing pharmaceutical actives. Such kits include those designed to dispense active ingredients on a continuous daily frequency. Seg, e.g.,

U.S. Pat. No. 5,265,728, to Allendorf et al., issued Nov. 30, 1993; EP Pub. 0 511 726 A2, to

Berlex Laboratories, Inc., published Nov. 4, 1992; ¥PCT Pub. WO 99/51214, to Akzo Nobel, . published Oct. 14, 1999; and U.S. Pat. No. 4,958,736, to Urheim, issued Sept. 25, 1990, which describe dispensers for administering various pharmaceuticals, including oral contraceptives, on a continuous daily basis, including regimens wherein thes active ingredient is administered daily for about 21 days followed by placebo administration for a bout seven days. Other kits and dispensers have been developed that are designed for adminissering multiple doses of the same active ingredient per day, or for the concurrent or nonconcuzrent administration of two or more active agents. See, e.g., U.S. Pat. No. 6,024,222, to Friberg et al., issued Feb. 15, 2000; U.S. Pat. No. 6,219,997, to Friberg et al, issued Apr. 24, 2001; U.S _ Pat. Pub. 2003/0168376 Al, Taneja et al., published Sept. 11, 2003; U.S. Pat. Pub. 2003/01114779, Taneja et al., published June 19, 2003;

U.S. Pat. No. 6,375,956, to Hermelin et al., issued Apr. 23, 2002; PCT Pub. WO 88/02342, Astra

Likemedel Aktiebolag, published Apr. 7, 1988; U.S. Pat. No. 4,295,567, to Knudsen, issued Oct. 20, 1981; DE 297 19 070, to Byk Gulden Lomberg C hemische Fabrik, published June 25, 1998;

U.S. Pat. No. 5,848,976, to Weinstein, issued Dec. 15, 1998; U.S. Pat. No. 6,270,796, to

Weinstein, issued Aug. 7, 2001; U.S. Pat. No. 6,564,945, to Weinstein et al, issued May 20, 2003; and U.S. Pat. No. 5,788,974, to D’ Amico et al., issued Aug. 4, 1998. A kit has also been disclosed for the administration of an active ingredient on a omce weekly basis. See U.S. Pub. 2001/0044427, Mazel et al., published Nov. 22, 2001. However, none of these aforementioned kits or dispensers is designed or intended to address the compliance issues associated with the continuous administration of a pharmaceutical active on a frequency other than daily together : with taking a separate associated nutrient on the days in between the days the active ingredient is administered.

Applicants have developed a dispensing means that addresses the issues presented.

Applicants have found that the present invention simplifies complex therapies and aids patients in understanding how to take their medication and accompanyings nutrients, which can then lead to greater compliance with complicated treatment regimens, for: example, regimens wherein the patient takes a unit dose of an active ingredient on a continuou s frequency other than daily and a unit dose of a nutrient on the days in between the days the patiemnt takes the active dose.

The present invention is particularly useful in treatment regimens wherein the active ingredient is a bisphosphonate and the nutrient is calcium or a calcium-containing supplement.

Patients taking bisphosphonates arc generally instructed to ®ake a daily calcium supplement, however, the bisphosphonate and the calcium supplement showuld not be taken at the same time.

Because bisphosphonates chelate calcium, taking a unit dose of” a bisphosphonate at the same time as a calcium supplement interferes with the absorption of the bwisphosphonate, thereby potentially decreasing the cfficacy of the bisphosphonate. The kit of th e present invention addresses this issue. By taking the unit doses of nutrient on the days in betwveen the days the patient takes the active dose, the patient avoids the problems associated with the simultaneous dosing of both a bisphosphonate and a calcium-containing supplement. Appli_cants have found that the present invention aids patients in understanding when and how to tzake bisphosphonates and calcium- containing supplements, which can lead to greater patient compoliance and maximum benefit from such treatment regimens.

SUMMARY OF THE INVENT ION

The present invention relates to a kit (i.e., article o-f manufacture) for promoting the proper sequential oral administration of a pharmaceutically active ingredient and accompanying nutrients, said kit comprising:

(a) at least one unit dose of a pharmaceutical active to be given continuously on a frequency of once a week, twice a week, once every two weeks, twice a month, or once a month; (b) at least one unit dose of a nutrient to be given subsequent to the active dose administration; and (c) a blister card individually and releasably containing the unit doses; wherein said unit doses of pharrmaceutical active and nutrient are arranged horizontally or vertically in order of their use across the blister card.

Preferably, the pharmaceutical active is a bisphosphonate and the nutrient is calcium, vitamin D, or a combined unit dose of calcium and vitamin D.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of the front of a blister card. [FIG. 2 is a plan view of the back of the blister card of FIG. I.

FIG. 3 is a plan view of the front of a blister card.

FIG. 4 is a plan view of the front of a blister card.

FIG. 5 is a plan view of the front of a blister card.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to kits for the pharmaceutical administration of an active ingredient and accompanying nutrients. The kits are especially useful in treatment regimens comprising the administration of a bisphossphonate once a week and calcium and/or vitamin D on the days in between the days the patient takes the bisphosphonate dose.

The terms “bisphosphonate” and “diphosphonate,” as used herein, include acids, salts, esters, and derivatives thereof. The bisphosphonates of the present invention include those preferred compounds containing a nitrogzen atom. Nonlimiting examples of bisphosphonates useful herein include the following: 1-hydroxy-2-(3-pyridinyl)-ethylidene-1,1-bisphosphonic acid (risedronate) as described in U.S. Pat. No. 5,583,122, to Benedict et al., issued Dec. 10, 1996; 4-

amino- |-hydroxybutylidene-1,1-bisphosphonic acid (alendronic acid or alendronate) as described in U.S. Pat. No. 4,621,077, to Rosini et al., issued Nov. 4, 1986; U.S. Pat. No. 4,922,007, to

Kizcoykowski ct al, issued May 1, 1990; U.S. Jat. No. 5,019,651, to Kieczykowski, issued May 28, 1991; 3-amino-1-hydroxypropylidene- 1,1-bisphosphonic acid (pamidronate); “4- c¢hlorophenyl)thiomethane-1,1-diphosphonic acid (tiludronate) as described in U.S. Pat. No. 4,876,248 to Brelicre ¢t al., issued Oct. 24, 19829; 1.1-dichloromethylene-1,1-diphosphonic acid (clodronate) as described in Belgium Patent 672,205 (1966); cycloheptylaminomethylene-1,1- bisphosphonic acid (cimadronate), as described in U.S. Pat. No. 4,970,335, to Isomura et al., issued Nov. 13, 1990; 1-hydroxy-3-(N-meth yl-N-pentylamino)propylidene-1,!-bisphosphonic acid (ibandronatc), which is described in U.S. Pat. No. 4,927,814, issued May 22, 1990; 1- hydroxy-2-(imidazol-1-yl)ethane-1,1-bisphosphonic acid ~~ (zoledronate); and 1-(N- phenylaminothiocarbonyl)methane-1,1-bisphospehonic acid. “Blister cards” are well known in thee packaging industry and are widely used for packaging pharmaceutical unit doses. The blister cards of the present invention individually and releasably contain the unit doses of pharmaceutical active and nutrient.

The terms “continuous” and “continuously,” as used herein, mean at regular specified intervals. For example, a continuous frequency of once a week means that the active is given once a week for an unspecified period of time or for as long as treatment is necessary.

The term “once a week” or “once weekzly” means that a unit dose is administered once a week, i.e., one time during a seven day perioed. The term “twice a week” or “twice weekly” mcans that a unit dose is administered twice a week, i.e., twice during a seven day period. In a twice weekly regimen, the unit doses may be administered on consecutive days during the seven day period, or may be administercd about every three to four days. The term “every two weeks” means that a unit dose is administered once during a two week period, i.e., one time during a fourteen day period. The term “twice a month” or “twice monthly” means that a unit dose is administered twice, i.e., two times, during a monthly calendar period. In a twice monthly regimen, the unit doses may be administered om consecutive days, or may be administered once about every fourteen to sixteen days. The term “once a month” or “once monthly” means that a unit dose is administered once, 1.¢., one time dur-ing a monthly calendar period.

The term “unit dose” or “unit dosage’ > means a dosage form containing an amount of pharmaceutical active or nutrient suitable for administration in one single dose, according to sound medical practice. The kits of the present invention are particularly useful for the administration of unit doses in the form of tablets and capsules.

The term “combined unit dose of calcium and vitamin I,” as used herein, means a single unit dose form comprising both <alcium and vitamin D.

The term “IU,” as used herein, means International Units. One microgram of vitamin D is approximately 40 International Units.

The frequency of administration of the pharmaceutical active depends on the treatment to be administered. A particu larly preferred treatment is the once weekly dosing of a bisphosphonate for the treatment of osteoporosis. The bisphosphonate is administered in an amount that has been determined to be therapeutically effective. For example, risedronate may be administered at a dose of 35mg per week. Alendronate may be administered at doses of 70 mg and/or 35 mg per week. Other treatment regimens for bisphosphonates may include those for cancer, Paget's disease, and other bone resorptive disorders.

The term “nutrient,” as used herein, means any nutritional or dietary supplement including but not limited to -~vitamins, minerals, amino acids, herbs or other botanicals, or concentrates, metabolites, constituents, extracts, or combinations of the same.

The preferred nutrients to be administered in the bisphosphonate regimen are calcium and/or vitamin D. Oral forms of calcium suitable for use in the present invention include capsules, compressed tablets, chewable tablets, and the like. Typical salt forms of calcium suitable for use in the present imvention include but are not limited to calcium carbonate, calcium citrate, calcium malate, calciurm citrate malate, calcium glubionate, calcium gluceptate, calcium cluconate, calcium lactate, dibasic calcium phosphate, and tribasic calcium phosphate. Different salt forms of calcium contain different percentages of elemental calcium. For example, calcium carbonate contains about 40% elemental calcium (i.e., 1000 mg calcium carbonate contains about 400 mg elemental calcium). Im one embodiment of the invention, calcium can be administered at doses of 400 mg to 1500 mg of clemental calcium per day, on the days in between the days when the patient takes a unit dose of pharmaceutical active.

The term “vitamin D, > as used herein, refers to any form of vitamin D that may be administered to a mammal as a nutrient. Vitamin D is metabolized in the body to provide what is often referred to as “activated” forms of vitamin D. The term “vitamin D” can include activated and non-activated forms of vitamin D, as well as precursors and metabolites of such forms.

Precursors of these activated forms include vitamin D, (ergocalciferol, produced in plants) and vitamin D; (cholecalciferol, produced in skin and found in animal sources and used to fortify foods). Vitamins D, and Ds; have similar biological efficacy in humans. Non-activated metabolites of vitamins D; and Ds include hydroxylated forms of vitamins D» and D;. Activated vitamin D analogs cannot bc administered in large doses on an intermittent schedule, due to their toxicity in mammals. However, non-activated vitamin D,, vitamin Dj, and their metabolites may be administered in larger doses than “active” forms of vitamin D on an intermittent basis, without toxicity. In one embodiment of the invention, vitamin D can be administered at doses of 100 TU to 10,000 1U of vitamin D per day, on the days in between the days when the patient takes a unit dose of pharmaceutical active.

In another embodiment of the invention, thc nutrient is a unit dose comprising both calcium and vitamin D. In a further embodiament, the unit dose comprises 600 mg elemental calcium and 400 [U vitamin D, to be administered on the days in between the days when the patient takes the unit dose of the pharmaceutica 1 active.

The kits of the present invention are particularly useful for administering pharmaceutical actives such as bisphosphonates on a weekly b asis. The kits comprise at least one unit dose of a pharmaceutical active and at least one unit dose of a nutrient on a single blister card. In addition, the kits may include means for aiding the mermory on the card. More than one week of dosage units may be present on one card and more thar one card may be packaged together.

In one embodiment of the present invertion, the blister card comprises a means for aiding the memory. Means for aiding the memory cara include but are not limited to a listing of the days of the week, numbering, illustrations, arrows, WBraille, calendar stickers, reminder cards, or other means specifically selected by the patient.

In one embodiment, the kit of the pres ent invention provides a blister card comprising a unit dose of a pharmaceutical active suitable for once weekly dosing, and six unit doses of a nutrient, to be taken on the days in between thes days the patient takes the weekly pharmaceutical active unit dose. In another embodiment of the invention, the blister card comprises a unit dose of a pharmaceutical active suitable for once weeskly dosing and twelve unit doses of a nutrient, wherein two doses of nutrient are taken each day on the days in between the days the patient takes the weekly pharmaceutical active. Preferably, the pharmaceutical active is a bisphosphonate and the nutrient is calcium, vitamin D, calcium and vitamin D, or a combined unit dose of calcium and vitamin D.

In a further embodiment of thes present invention, the blister card comprises, in vertical arrangement in order of their use, a uit dose of a pharmaceutical active followed by six unit doses of a nutrient. In another embodiment of the invention, the blister card comprises, in vertical arrangement in order of their use, a unit dose of a pharmaceutical active suitable for once weekly dosing followed by twelve unit doses o»f a nutrient, wherein two doses of nutrient are taken each day on the days in between the days the patient takes the weekly pharmaceutical active. When two unit doses of nutrient are to be tal<en on the same day, the daily allotment of unit doses of nutrient can be arranged vertically or horizontally across the blister card. In a further embodiment of the invention, the kit can comprisse at least two blister cards, wherein each blister card comprises doscs suitable for one week of treatment therapy. In another embodiment, the kit can comprise at least four blister cards, wherein each blister card comprises doses suitable for one week of treatment therapy. In another embodiment of the invention, the blister card comprises two vertical columns of unit doses, wherein each vertical column comprises one unit dose of a pharmaceutical active and six or twelve unit doses of a nutrient. In a further embodiment of the invention, the blister card comprises feour vertical columns of unit doses, wherein each vertical column comprises onc unit dose of a pharmaceutical active and six or twelve unit doses of a nutrient. In yet another embodiment of the present invention, the blister card comprises two vertical columns of doses, wherein eack column comprises unit doses sufficient for two weeks of therapy, arranged in order of their use (i.e., two vertical columns, each comprising a first unit dose of a pharmaceutical active, followed bey six unit doses of a nutrient, followed by a second unit dose of a pharmaceutical active, follo-wed by six more unit doses of a nutrient, for a total of fourteen unit doses per column). Preferably, the pharmaceutical active is a bisphosphonate and the nutrient is calcium, vitamin D, calci-um and vitamin D, or a combined unit dose of calcium and vitamin D.

In an alternate embodiment of the invention, the blister card comprises, in horizontal arrangement in order of their use, a unit dose of a pharmaceutical active followed by six unit doses of a nutrient. In another embodiment of the invention, the blister card comprises, in horizontal arrangement in order of thedir use, a unit dose of a pharmaceutical active suitable for once weekly dosing followed by twelve unit doses of a nutrient, wherein two doses of nutrient are taken each day on the days in between the days the patient takes the weekly pharmaceutical active. When two unit doses of nutriemt are to be taken on the same day, the daily allotment of unit doses of nutrient can be arranged vertically or horizontally across the blister card. In a {further embodiment of the invention, the kit can comprise at least two blister cards, wherein each blister card comprises doses suitable fost one week of treatment therapy. In another embodiment,

WC) 2004/087038 PCT/US2004/009595 thes kit can comprise at least four blister cards, wherein each blistesr card comprises doses suitable for- one week of treatment therapy. In another embodiment of” the invention, the blister card zoxnprises two horizontal rows of unit doses, wherein cach horizontal row comprises one unit

Jose of a pharmaceutical active and six or twelve unit dose s of a nutrient. In a further cimbodiment of the invention, the blister card comprises four horizontal rows of unit doses, wimerein cach horizontal row comprises one unit dose of a pharmasceutical active and six or twelve unit doses of a nutrient. In yet another embodiment of the pressent invention, the blister card cornprises two horizontal rows of doses, wherein each row comprises unit doses sufficient for two vezeks of therapy, arranged in order of their use (i.e., two horizon®al rows, each comprising a first unit dose of a pharmaceutical active, followed by six unit doses of a nutrient, followed by a second unit dose of a pharmaceutical active, followed by six more unit doses of a nutrient, for a total of fourteen unit doses per row). Preferably, the pharmaceu tical active is a bisphosphonate and the nutrient is calcium, vitamin D, calcium and vitamin D, or & combined unit dose of calcium and vitamin D.

The present invention provides a kit for providing co-mplex therapeutic regimens to patients in a simplified manner, which can then lead to increased poatient compliance. The figures exemplify an embodiment of the present invention.

Referring to FIG. 1, the blister card comprises cavitics 10 in which the unit doses of the pharmaceutical active are contained. The general structure of thesse blister cards is well known in thes art. These can comprise a clear or opaque film layer containirag blister cavitics 10 heat-scaled to a foil layer which includes indicia on one or both sides. The blister card further comprises cawities 11 in which the unit doses of nutrient are contained. It iss appreciated that the individual blisters may vary in sizc and shape, depending on the size of shape of the unit dose of pharmaceutical active or nutrient releasably contained therein. As illustrated in FIG. 2, each blister card is printed with information to aid the patient in takirmg the doses. Such information inc ludes the relative order of use in the treatments 30, the poroduct name 31 and 33, and instructions as to when or how to take the dose 34.

The blister card of one embodiment of the present invention, presented in FIG. 1, contains one cavity 10 in which the unit dose of a pharmaceutical active is contained and six cavities 11 in whch the unit doses of nutrient are contained to be taken on subs equent days for one week. The bacsk of the blister card, FIG.2, provides memory aids 32 to reflect the appropriate information for prosper dosing.

Referring to FIG. 3, another embodiment of the invention is shown wherein the blister card comprises four rows, each row containing onc cavity 10 in which the unit dose of the pharsnaceutical active is contained and six cavities 11 in which the unit dosess of nutrient are contained. The patient takes one unit dose of a pharmaceutical active and then takes six unit dosess of a nutrient on subsequent days, repeating this process four times.

Referring to FIG. 4, yet another embodiment of the invention is shown v=vherein the blister card comprises one cavity 10 in which the unit dose of the pharmaceutical actives is contained and twelve cavities 11 in which the unit doses of nutrient are contained. The patient takes one unit dose of a pharmaceutical active and then takes two unit doses of a nutri ent each day on subsequent days for one week.

Referring to FIG. 5, still another embodiment of the invention is simown wherein the blister card comprises two rows, each row containing a first cavity 10 in whi ch a unit dose of phartmaceutical active is contained, followed by six cavities 11 in which unit do=ses of nutrient are contained, followed by a second cavity 10 in which a unit dose of pharma ceutical active is contained, followed by six more cavities 11 in which unit doses of nutrient are contained. In this embodiment, cach row contains unit doses of pharmaceutical active and nutrient sufficient for two weeks of therapy when the pharmaceutical active is taken on a once weekly basis.

EXAMPLES

Example 1

A 75-year-old female patient diagnosed with osteoporosis is prescribed a weekly dose of m.g risedronate, in combination with calcium. The patient has difficulty rermembering which day of the week she takes the risedronate dose, and occasionally forgets to take the calcium supplement, or takes the calcium supplement at the same time as she takes the risedronate weekly dose, thereby reducing the efficacy of the risedronate unit dose. The patient is presented with a bliste-r card of the present invention, which contains in horizontal arrangement a unit dose of risedronate followed by six unit doses of 600 mg each elemental calcium. The blister card conta.ins printed information which instructs the patient as to how and in whickh order the doses are tow be taken. The patient finds that this blister card is easy to use and aids he r in remembering to tal<e the risedronate on a weekly basis as well as the calcium supplement on the days in betwezen the days she takes the risedronate doses. The patient also avoids -taking a calcium suppl ement at the same time as she takes the risedronate unit dose, thus av-oiding undesired interaction betw een the two. The patient shows increased compliance with her prescribed treatment regime n.

Example 2 4 55-year-old female patient at risk for ostcoporosis is prescribed a weekly dose of 35 mg risedronate in co mbination with a calcium and vitamin D supplement, as a prevemtative measure.

I'he patient is presented with a blister card of the present invention, which contains four rows in horizontal arrangsement, each row containing a unit dose of risedronate followed bby six unit doses of a nutrient, cach containing 600 mg elemental calcium and 400 IU vitamin D. The blister card contains printed information which instructs the patient as to how and in which order the doses are to be taken. The patient uses this blister card for four weeks and finds that the package aids her in understanding her therapy and complying with her doctor’s prescribed tre atment regimen.

The patient compplies with instructions to take risedronate once a week and to ta¥ke a supplement of calcium and vitamin D on the days in between the days she takes the rised ronate doses, in accordance with her doctor’s instructions.

Example 3

A 67-year-old female patient diagnosed with osteoporosis is prescribed a weekly dose of 70 mg alendronate, in combination with calcium. The patient has difficulty rem _embering which day of the week she takes thc alendronate dose, and frequently forgets to take the calcium supplement. The patient is presented with a blister card of the present invention, which contains in vertical arrangement a unit dose of alendronate followed by six unit doses «of 600 mg each elemental calciurm. The blister card contains printed information which instructs the patient as fo how and in which order the doses are to be taken. The patient finds that this blister card is easy to use, and that it aids her in remembering to take the alendronate on a weekly bas is as well as the calcium supplement on the days in between the days she takes the alendronate do ses. The patient shows increased compliance with her prescribed treatment regimen.

Example 4

A 58-year-old female patient at risk for osteoporosis is prescribed a weekly dose of 35 mg alendronate in combination with a calcium and vitamin D supplement, as a preventative measure.

The patient is presented with a blister card of the present invention, which conta ins four rows in vertical arrangenent, each row containing a unit dose of alendronate followed by six unit doses of a nutrient, each containing 600 mg elemental calcium and 400 IU vitamin D. The blister card contains printed infor-mation which instructs the patient as to how and in which order the dosses arc to be taken. The patient uses this blister card for four weeks and finds that the package a-ids her in understanding Ther therapy and complying with her doctor’s prescribed treatment regimeen.

The patient complies “with instructions to take alendronate once a week, and to take a supplemeent of calcium and vitamin D on the days in between the days she takes the alendronate doses.

Example 5

A 75-year-olcl male patient diagnosed with osteoporosis is prescribed a weekly dose of ~ 35 mg risedronate, in cosmbination with vitamin D. The patient has difficulty remembering wh_ich day of the week he takes the risedronate dose, and does not take a vitamin D supplement. Whe patient is then presented with a blister card of the present invention, which contains in horizomtal arrangement a unit dose of risedronate followed by six unit doses, each containing 400 IU vitarmin

D. The blister card contains printed information which instructs the patient as to how andl in which order the dosess are to be taken. The patient finds that this blister card is easy to use, sand that it aids him in unclerstanding his therapy and remembering to take the risedronate on a weekly basis as well as the vitamin D supplement on the days in between the days he takes the risedronate doses. The patient sh_ows increased compliance with his prescribed treatment regimen.

Example 6

A 72-year-olad female patient diagnosed with osteoporosis is prescribed a weekly doses of mg risedronate, ira combination with 1200 mg elemental calcium daily, divided into two wnit doses each day. Thee patient has difficulty remembering which day of the week she takes the risedronate dose, aned occasionally forgets to take the calcium supplements. The patient is presented with a blister card of the present invention, which contains in horizontal arrangememt a unit dose of risedron.ate followed by twelve unit doses of 600 mg each elemental calcium. “The twelve unit doses of calcium are arranged in two rows following the unit dose of risedronate , as pictured in FIG. 4. The blister card contains printed information which instructs the patient ass to how and in which orcer the doses are to be taken. The patient finds that this blister card is easy 10 use and aids her in understanding her therapy and remembering to take the risedronate on a weekly basis as well as the calcium supplements on the days in between the days she takes the risedronate doses. Tihe patient is able to understand her treatment regimen, and shows increamsed compliance therewith.

Example 7

A 65-year-old fernale patient diagnosed with osteoporosis is prescribed a weekly dose of mg risedronate in coambination with a calcium and vitamin D supplement. The pzatient is presented with a blister czard of the present invention, which contains two rows of unit doses in horizontal arrangement, e=ach row containing a unit dose of risedronate followed by six urait doses of a nutrient, followed by a second unit dose of risedronate, followed by six more unit closes of nutrient, as pictured in FIG. 5. Each unit dose of nutrient contains 600 mg elemental calcium and 400 TU vitamin D. The blister card contains printed information which instructs the patient as to how and in which order the doses are to be taken. The patient uses this blister card for foumr weeks and finds that the packages aids her in understanding her therapy and complying with her «doctor’s prescribed treatment regimmen. The patient complies with instructions to take risedronate once a week and to take a supplement of calcium and vitamin D on the days in between the Hays she takes the risedronate dose s, in accordance with her doctor’s instructions.

Example §

A 65-year-old fermale patient diagnosed with osteoporosis is currently taking risezdronate on a weekly basis in combination with a calcium supplement. The patient is first shown =a blister card of the present invention, which contains in vertical arrangement a unit dose of riseadronate, followed by six unit dosses of calcium. The blister card contains printed informatiora which instructs the patient as to how and in which order the doses are to be taken. The patient: is then : shown a second blister caard having an alternate horizontal arrangement of unit doses, whe=rein the first row contains one undt dose of risedronate located in the center of the card, and the second row contains a horizontal arrangement of six unit doses of calcium. The second blister card also contains printed information which instructs the patient as to how and in which order th e doses are to be taken. The patient prefers the first blister card over the second blister carcd. She determines that the arramgement of unit doses of the first blister card would aid her in remembering to take both the risedronate active and the calcium supplements on the corre=ct days and in the correct manne. She also determines that the arrangement of the doses on the first blister card is clear and lesss confusing than the arrangement of the unit doses on the second blister card.

Example 9

A 70-year-old female patient diagnosed with osteoporosis is currently taking riseadronate on a weekly basis in combination with a calcium supplement. The patient is first shown an blister

Zo os do70k card of the present invention, which contains in horizontal arrangement a unit dose of risedronate, followed by six unit doses of calcium. T he blister card contains printed information which instructs the patient as to how and in which order the doses are to be taken. The patient is then shown a second blister card having an alternate horizontal arrangement of unit doses, wherein the first row contains one unit dose of risedronate located at the left-hand side of the card, and the second row contains a horizontal arrangement of seven unit doses of calcium. The second blister card also contains printed information which instructs the patient as to how and in which order the doses are to be taken. The patient prefers the first blister card over the second blister card. She determines that the arrangement of unit doses of the first blister card would aid her in remembering to take both the riscdronate active and the calcium supplements on the correct days and in the correct manner. She also deterrmines that the arrangement of the doses on the first blister card is clear and less confusing than tlae arrangement of the unit doses on the second blister card.

All documents cited are, in relevant part, incorporated herein by reference; the citation of any document is not to be construed as an admission that it is prior. art with respect to the present invention.

While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departirmg from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

Claims (1)

1. What is claimed is:

   1. A kit for promoting the proper sequential oral administration of a pharmace=utically active ingredient amd accompanying nutrients, said kit characterized by: (a) at le ast one unit dose of a pharmaceutical active to be given continuously on a frequiency of once a week, twice a week, once every two weeks, twice a month, or oncez a month; (b) at least one unit dose of a nutrient to be given subsequent to the active dose admanistration; and (c) ablister card individually and releasably containing the unit doses; wherein said unit doses of pharmaceutical active and nutrient are arranged horizontally or vertical ly in order of their use across the blister card.

   2. The kit of CEaim 1 wherein the pharmaceutical active is a bisphosphonate amd the nutrient is selected {r om the group consisting of calcium, vitamin D, calcium and vitamin D, and a combined urmit dose of calcium and vitamin D.

   3. The kit of C=laim 2 wherein the bisphosphonate is selected from the group consisting of risedronate, alendronate, pamidronate, tiludronate, cimadronate, ibaradronate, and zoledronate. 4, The kit of an_y of the Claims 1-3 wherein the blister card comprises a meanss for aiding the memory.

   3. The kit of adiy of the Claims 1-4 wherein the unit doses of pharmaceutical active and nutrient are arranged horizontally in order of their use across the blister cardi.

   6. The kit of aray of the Claims 1-5 wherein the blister card is characterized toy two or four horizontal rosws of unit doses, wherein each horizontal row is characterizeed by one unit dose of a pharmaceutical active and six unit doses of a nutrient.

   7. The kit of amy of the Claims 1-4 wherein the unit doses of pharmaceutical active and nutrient arc anrranged vertically in order of their use across the blister card,

   8. The kit of any of the Claims 1-4 and Claim 7 whereim the blister card is characterized by two or four vertical columns of unit doses, wherein ezach vertical column is characterized by ane unit dose of a pharmaceutical active and six unit doses of a nutrient. a, The kit of any of the Claims 1-5 and Claim 7 whereirm the blister card is characterized by anc unit dose of a pharmaceutical active and six unit d«oses of a nutrient.

   fo. The kit of any of the Claims 1-9 wherein the kit js characterized by from two to four blister cards, it A method for increasing compliance with u treatment regimen characterized by providing a person in need thereof the kit of any of the Claims 1-10.

   12. A kit for promoting the proper sequential oral administration of a pharmaceutically active ingredient and accompanying nutrients, substantially as described in any one of the examples given or as described with referen ce to any one of the accompanying drawings. AMENDED SHEET