Claims for Patent: 9,622,975

Summary for Patent: 9,622,975

Title:	Pharmaceutical composition
Abstract:	The present invention provides oral pharmaceutical compositions that enable the successful delivery of drugs in a pharmaceutically effective amount, particularly poly (amino acids) such as peptides, peptidomimetics and proteins. e.g. hormones to a subject via oral administration to accomplish the desired therapeutic effect. The oral pharmaceutical composition comprising a poly (amino acid) as the active ingredient, e.g. a peptide or protein, shows a rapid disintegration and/or dissolution such that the active ingredient is able to attain a therapeutic effect.
Inventor(s):	Azria; Moise (Basel, CH), Bateman; Simon David (Randolph, NJ), Ghosh; Anasuya Ashok (Basking Ridge, NJ), Li; Shoufeng (Basking Ridge, NJ), Royce; Alan Edward (Saylorsburg, PA)
Assignee:	Novartis AG (Basel, CH)
Application Number:	14/718,595
Patent Claims:	1. An oral pharmaceutical composition in compressed tablet form comprising: i. parathyroid hormone (PTH) or a fragment thereof comprising at least amino acids 1 to 28 in an amount of about 1 .mu.g/kg to about 6 .mu.g/kg body weight: ii. N-(5-chlorosalicyloyl)-8-aminocaprylic acid (5-CNAC) in an amount of between 40 wt % and 60 wt % as delivery agent; (iii) crospovidone as a disintegrant in an amount of from 1.0 wt % to 8 wt %; and (iv) Avicel as a diluent in an amount of from 20 wt % to 70 wt %; wherein the composition has a disintegration time of no more than 6 minutes and a dissolution of >90% at 20 minutes and wherein the tablet has a hardness of between 3 Kp and 20 Kp. 2. The composition of claim 1, wherein the composition has a disintegration time of no more than 2 minutes. 3. The pharmaceutical composition of claim 1, wherein the tablet has a hardness of between 5 Kp and 15 Kp. 4. The pharmaceutical composition of claim 1, wherein the tablet has a disintegration time of less than 1 minute and a hardness of between 5 Kp and 7 Kp. 5. The composition of claim 1, wherein the PTH is PTH 1-34. 6. A method of manufacturing an oral pharmaceutical composition in compressed tablet form comprising the steps: i. blending parathyroid hormone (PTH) or a fragment thereof comprising at least amino acids 1 to 28 in an amount of about 1 .mu.g/kg to about 6 .mu.g/kg body weight with N-(5-chlorosalicyloyl)-8-aminocaprylic acid (5-CNAC) in an amount of between 40 wt % and 60 wt %, crospovidone in an amount of from 1.0 wt % to 8 wt %, and Avicel in an amount of from 20 wt % to 70 wt % to make a blend; and ii. compressing the blend into a tablet having a hardness of between 3 Kp and 20 Kp, wherein the composition has a disintegration time of no more than 6 minutes and a dissolution of >90% at 20 minutes. 7. The composition of claim 1 wherein the tablet does not include an enteric coating. 8. The composition of claim 7 wherein the tablet does not include a peptidase inhibitor.

Details for Patent 9,622,975

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2025-11-17