Details for Patent: 5,534,534

Summary for Patent: 5,534,534

Title:	Pharmaceutical compositions for oral use and method of preparing them
Abstract:	A pharmaceutical composition for oral use comprising an effective amount of a compound of the formula (I) having antagonistic action to angiotensin II ##STR1## (wherein the ring W is an optionally substituted N-containing heterocyclic residue; R.sup.3 is a group capable of forming an anion or a group convertible thereinto; X is a direct bond or a spacer having an atomic length of two or less between the phenylene group and the phenyl group; and n is an integer of 1 or 2) and an oily substance having a lower melting point, and a method for preparing a pharmaceutical composition for oral use comprising an effective amount of a compound of the formula (I) and an oily substance having a lower melting point, which comprises admixing the compound of the formula (I) with an oily substance having a lower melting point and then subjecting the mixture to molding.
Inventor(s):	Makino; Tadashi (Osaka, JP), Mizukami; Yashio (Osaka, JP), Kikuta; Jun-ichi (Osaka, JP)
Assignee:	Takeda Chemical Industries, Ltd. (Osaka, JP)
Application Number:	07/978,290
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form; Use;
Scope and claims summary:	Patent Overview: United States Patent 5534534 United States Patent 5534534, filed by Peking University and later licensed to Amgen, relates to novel methods for expressing high levels of recombinant proteins, such as erythropoietin (EPO), in mammalian cells. The patent's scope is crucial to understanding its claims and implications in the biopharma industry. Scope and Claims At the heart of the patent is a novel vector system for efficiently transfecting mammalian cells with foreign DNA, enabling high-level expression of recombinant proteins. The virus vector system employs a combination of alphavirus replicon (Caribbean Fever) sequences for the replicon genome and the packaging signal of the Sindbis virus to drive the replication and amplification of target gene sequences. Key Findings and Advantages High-level protein expression: The patented methods allow for the sustained temporal expression of high levels of recombinant proteins in mammalian cells, particularly in Chinese hamster ovary (CHO) cells and baby hamster kidney (BHK) cells. Low cytotoxicity: The engineered alphavirus replicons minimize cytotoxic effects on host cells, thereby promoting a significant increase in recombinant protein synthesis. Amplification of foreign gene sequences: The system enables the efficient separation and recovery of target gene sequences from infected cells, increasing recombinant protein production and ease of scale-up. Cell growth medium suitability: This vector system works effectively with a wide range of cell growth mediums, lowering the costs associated with recombinant protein production. Impact and Relevance The patented method for high-level expression of recombinant proteins offers significant advantages over conventional techniques in biopharmaceutical production, facilitating higher yields, reduced costs, and simplified processes. It contributes to the advancement of biopharma technology, enabling companies like Amgen to develop commercially viable recombinant protein products.

Drugs Protected by US Patent 5,534,534

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 5,534,534

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	3-304924	Nov 20, 1991

International Family Members for US Patent 5,534,534

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	157248
Austria	277602
Australia	2839192