Chewable molded tablet containing medicinally active substances

• US 5,753,255 A
• Filed: 02/11/1997
• Issued: 05/19/1998
• Est. Priority Date: 02/11/1997
• Status: Expired due to Fees

• Current Assignee: Leonard Chavkin, Leonard Mackles
• Original Assignee: Leonard Chavkin, Leonard Mackles
• Inventors: Mackles, Leonard, Chavkin, Leonard
• Primary Examiner(s): Nagumo, Mark
• Application Number:
  US08/795,472
• Time in Patent Office: 462 Days
• Field of Search: 424/441, 424/465, 514/785, 514/786, 514/961
• US Class Current: 424/441
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals

Abstract

There is provided a chewable medicinal tableting composition comprising as proportions of the total composition which will further comprise the medicinally active component, as first essential component: capric triglyceride: about 30 to about 95% by weight, and as second essential component: the medicinally active ingredient: up to 60% by weight. Where the medicinally active ingrdient is less than about 30% by weight the composition further comprises as third essential component, a member of the group consisting of glyceryl monostearate, a mixture of glyceryl monostearate and glyceryl monopalmitate, and a mixture comprising at least about 40-50% by weight of glyceryl monostearate, and glyceryl distearate: up to 10% by weight. There are also disclosed methods of making these compositions.

Claims

1. A chewable medicinal molding tableting composition comprising, as proportions of the total composition which will further comprise the medicinally active component, as first essential component:

capric triglyceride;

about 30 to about 95% by weight,

as second essential component;

the medicinally active ingredient;

up to 60% by weight and

as third essential component, a member of the group consisting of glyceryl monostearate, a mixture of glyceryl monostearate and glyceryl monopalmitate, and a mixture comprising at least about 40-50% by weight of glyceryl monostearate, and glyceryl distearate;

1 to 10% of capric triglyceride by weight.

2. The composition of claim 1 wherein the third component is a mixture of glyceryl monostearate and glyceryl monopalmitate.

3. The composition of claim 1 wherein the third component is present in the range of from about 1 to about 5% by weight of the said first component.

4. The composition of claim 3 wherein the third component is present in the range of from about 2 to about 4% by weight of the said first component.

5. A chewable medicinal molded tablet comprising, as proportions of the total composition, as first essential component:

capric triglyceride;

about 30 to about 95% by weight,

as second essential component;

the medicinally active ingredient;

up to 60% by weight, and

as third essential component;

a member of the group consisting of glyceryl monostearate, a mixture of glyceryl monostearate and glyceryl monopalmitate, and a mixture comprising at least about 40-50% by weight of glyceryl monostearate and glyceryl distearate;

1 to 10% of capric triglyceride by weight.

6. The tablet of claim 5 wherein the third component is present in the range of from about 1 to about 5% by weight of the said first component.

7. The tablet of claim 6 wherein the third component is present in the range of from 2 to about 4% by weight of the said first component.

8. A method of making a chewable molded medicinal tablet comprising as proportions of the total composition as first essential component:

capric triglyceride;

about 30 to about 95% by weight,

as second essential component;

the medicinally active ingredient;

up to 60% by weight, and

as third essential component;

a member of the group consisting of glyceryl monostearate, a mixture of glyceryl monostearate and glyceryl monopalmitate, and a mixture comprising at least about 40-50% by weight of glyceryl monostearate and glyceryl disparate;

1 to 10% of capric triglyceride by weight which comprises heating said first and said second components together to about 60°

to about 70°

C. to melt, mixing to obtain homogeneity and adding said medicinally active component to form a mixed melt, pouring said mix melt into molds and cooling.

9. The method of claim 8 additionally comprising the steps of adding amd homogeneously mixing in further components sequentially after the medicinally active component prior to cooling to hardening provided that where flavorants are added they are added above hardening temperature but below 50°

C.

10. The method of claim 9 wherein the third component is present in the range of from about 1 to about 5% by weight of the said first component.

11. The method of claim 8 wherein the third component is a mixture of glyceryl monostearate and glyceryl monopalmitate.

12. The method of claim 11 wherein the third component is present in the range of from about 2 to about 4% by weight of the said first component.