Combination enzyme for cystic fibrosis
A stable preparation of digestive/pancreatic enzymes which can be readily formed into a dosage formulation is provided as a treatment of pancreatic insufficiency in persons having cystic fibrosis. The dosage formulation can be administered either by an oral preparation including, but not limited to, a microcapsule, mini-capsule, time released capsule, sprinkle or other methodology. A further object of this invention is to provide a stabilized preparation of a combination medicant which resists degradation by light, heat, humidity or association with commonly used excipients.
1 . A pharmaceutical preparation to treat pancreatic disorders comprising a therapeutically effective amount of digestive/pancreatic enzymes selected from the group consisting of: amylase, lipase, protease, chymotrypsin, trypsin, papaya, and papain, and a combination thereof.
2 . The pharmaceutical preparation of claim 1 , wherein the preparation comprises protease, amylase and lipase.
3 . The pharmaceutical preparation of claim 1 wherein the preparation comprises protease, amylase, lipase and chymotrypsin.
4 . The pharmaceutical preparation of claim 1 wherein the preparation comprises protease, amylase, lipase, chymotrypsin, and papain.
5 . The pharmaceutical preparation of claim 1 wherein the preparation comprises protease, amylase, lipase, trypsin, chymotrypsin, and papain.
6 . The pharmaceutical preparation of claim 1 wherein the preparation comprises protease, amylase, lipase, trypsin, chymotrypsin, pancreatin and papain
7 . The pharmaceutical preparation of claim 1 wherein the enzymes are derived from animal sources.
8 . The pharmaceutical preparation of claim 1 wherein the enzymes are synthetic.
9 . The pharmaceutical preparation of claim 1 wherein the preparation is used to treat pancreatic enzyme insufficiency associated with cystic fibrosis.
10 . (canceled)
11 . The pharmaceutical preparation of claim 1 wherein the preparation is manufactured using the Prosolv technology.
12 . The pharmaceutical preparation of claim 1 wherein the preparation is manufactured utilizing a direct compression technology.
13 . The pharmaceutical preparation of claim 1 wherein the enzymes are derived from plant sources.
14 . The pharmaceutical preparation of claim 1 wherein the enzymes are derived from a combination of animal and plant sources.
15 . The pharmaceutical preparation of claim 1 , wherein the preparation is administered orally via a dosage formulation selected from the group consisting of: pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, and a combination thereof.
16 . The pharmaceutical preparation of claim 1 , wherein the preparation is resistant to degradation by light.
17 . The pharmaceutical preparation of claim 1 , wherein the preparation is resistant to degradation by heat.
18 . The pharmaceutical preparation of claim 1 , wherein the preparation is resistant to degradation by humidity.
19 . The pharmaceutical preparation of claim 1 , wherein the preparation is resistant to degradation by association with an excipient.
20 . The pharmaceutical preparation of claim 1 , wherein the preparation is made by direct compression.
21 . The pharmaceutical preparation of claim 1 , wherein the preparation is made by dry granulation.
22 . The pharmaceutical preparation of claim 1 , wherein the preparation is made by wet granulation.
23 . A method for the manufacture of a pharmaceutical preparation by direct compression comprising the steps of:
forming an active blend by blending an intimate admixture of silicified microcrystalline cellulose and a therapeutic agent comprising one or more digestive enzymes;
forming a color blend by blending an intimate admixture of a plurality of pharmaceutically acceptable dyes and a silicified microcrystalline cellulose;
combining the active blend, the color blend and a disintegrant into a preblend;
adding a lubricant to the preblend to form a final blend; and
compressing the final blend to form the pharmaceutical preparation.
24 . The method of claim 23 , wherein the silicified microcrystalline cellulose is ProSolv SMCC.
25 . The method of claim 23 , wherein the silicified microcrystalline cellulose has a particle size of 40 to 90 micrometers.
26 . The method of claim 23 , wherein the disintegrant is selected from the group consisting of: sodium starch glycolate, pregelatinized starch, cellulose, and a combination thereof.
27 . The method of claim 23 , wherein the lubricant is selected from a group consisting of: magnesium stearate, calcium stearate, talc, stearic acid, and a combination thereof.