DrugPatentWatch Database Preview➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing
« Back to Dashboard
Summary for Patent: 6,652,885
|Title:||Purification and stabilization of peptide and protein pharmaceutical agents|
|Abstract:||Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, i.e. undesirable components, from the peptide or protein. In a preferred embodiment, a peptide, such as insulin, containing one or more impurities, e.g., zinc ions, is entrapped in diketopiperazine to form a precipitate of peptide/diketopiperazine/impurity, which is then washed with a solvent for the impurity to be removed, which is a nonsolvent for the diketopiperazine and a nonsolvent for the peptide. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration. The formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the target biological membrane in order to facilitate transport. In a preferred embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. The charge on the insulin molecule is masked by hydrogen bonding it to the diketopiperazine, thereby enabling the insulin to pass through the target membrane. This method of delivering insulin results in a rapid increase in blood insulin concentration that is comparable to the increase resulting from intravenous delivery.|
|Inventor(s):||Steiner; Solomon S. (Mount Kisco, NY), Woods; Rodney J. (New Hampton, NY), Sulner; Joseph W. (Paramus, NJ)|
|Assignee:||MannKind Corporation (Danbury, CT)|
1. A method for delivering insulin to a patient in need thereof, comprising administering to the patient an effective amount of the insulin in a composition which comprises
microparticles of a diketopiperazine in which monomeric or dimeric insulin is complexed to the diketopiperazine.
2. The method of claim 1 wherein the diketopiperazine is fumaryl diketopiperazine.
3. The method of claim 2 wherein the composition is in a dry powder form administered to the lungs via inhalation.
4. The method of claim 1 wherein the patient is a Type II diabetic.
5. The method of claim 4 wherein the composition is administered concurrently with, or less than about 20 minutes prior to, the patient eating a meal.
6. The method of claim 1 wherein the composition is provided in one or more unit doses of insulin, each dose equivalent to about 6 IU of insulin.
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.