active pharmaceutical ingredients
How to identify the Complete Drug Patterns? Pharmaceutical companies invest huge dollars in R & D , production and marketing of a newly developed drug . As law, the patent term is 20 years , but it 's roughly 16 to 18 years in the case of drug patents , as they have to pass FDA regulations , before entering the markets. When the patent expires, generic companies come with the generic version of the same drug and selling in the market with a very low price . Therefore, to be competitive , innovative companies try to extend the lifetime of drugs. This is known as the extent of the drug known to protect longer. That is why a specific drug is not protected by a patent in particular , but is covered by various patents, including patents blocking . Patents do not protect drugs as such, but "inventions " . A better understanding of the different types of pharmaceutical patents and ways to extend the life of drug patents is essential for patent professionals involved in pharmaceutical research . Patent medicines can be classified into following categories: composition formulations Product form Drug release compound New chemical entity fitness Particle size selection patents The active metabolites prodrugs Dose / dose Method or process
The use or application Drug delivery devices 1) Composition Composition patent describes a combination of one or more of the ( known or novel), carriers or excipients and active ingredients such as solvents , buffers, fillers , binders, desintegrants , pharmaceutically acceptable lubricants . The inventiveness of these patents is on the selected combination of molecules and their specific application new feature. lidocaine hydrochloride In India, a new pharmaceutical composition with a single active ingredient (either known or novel) with an inert carrier is not patentable , since there is no synergy between the components viz. the active compound and the inert carrier. 2) Formulation A formulation patent relates to the preparation of the particular composition , in any particular desired shape for better effect , form or release . 2.1) Product Form: This refers to the different dosage form of new or already known composition or pharmaceutical drug delivery method has the most active drug. The active ingredient can be formulated in various forms , such as tablets, capsules or aqueous solutions for parenteral administration . For example, an anti- inflammatory cream containing A can be regarded as distinctly different from a tablet containing the "A" for the control of diabetes . The cream is new because "A" has never been formulated in this way before, and be inventive if the previous use of "A" would not recommend using topically . "
2.2 ) drug release : In some patents , the claimed formulation is associated with certain effects such as controlled release into the blood of a drug . Other drug delivery methods include timed extended and slow release .
3) Compound These related to the identification of a new chemical , biological molecule , or herbal patent medicines . The patent may or may not say anything about the composition ( when aggregated with other ingredients) , the application or use of such molecules . In most cases these new molecules are represented by different formulas in the claims ( claims Markush ) . These compounds may be new molecules form some sources (eg , biological , herbal ) or new chemical entity ( NCE). They can be
classified on the basis of the nature of the compound , ie , polymorph , isomer , ( crystalline or amorphous ) physical forms or salts . Local Anesthetics 3.1) new chemical entity : A new chemical entity ( NCE ) is usually represented by Markush structures in patent claims and reveals different chemical formulas and derivatives of new drugs. 3.2 ) Physical Form : Polymorphism and enantiomerism of chemicals property are exploited by pharmaceutical companies as the life cycle of drugs by novel polymorphs of the invention, isomers, physical forms (crystalline or amorphous ) , enantiomers of drug know . 3.3 ) Particle size: The dissolution rate of a drug is a function of its intrinsic solubility and particle size. Reduction of particle size can lead to increased dissolution rate and higher bioavailability , therefore a large number of patents in the pharmaceutical industries related to the composition to specific particle size of the ingredients along with dosage forms ( for example , suspensions or dispersions ) . 3.4) selection patents : In a ' selection patent "says a single item or a small segment within a larger group known is ' selected' and independently claimed based on a particular feature not mentioned in the large group . for example , a patent on a specific range (eg , C3 - C12 ) states if a chemical having n carbon atoms is already patented . 3.5) active metabolites : In some cases , patents are focused on a compound and the active metabolite that produces the desired effect in the body . The same effect than the parent drug compound is produced . 3.6 ) Prodrugs : when metabolized in the body inactive compounds (called " prodrugs " ) may produce a therapeutically active ingredient . Some patent claims cover a drug and prodrug / s . 4) Dose / dose Some patent documents claim inventions that consist of the dosage form for administration (e.g., solid dosage form for oral administration ) to patients of an existing product. These claims are usually coincides with claims on methods for medical treatment , and that matter is not a product or process, but the way a product is used therapeutically . 5 ) The method or process These patents disclose the method or process for the manufacture or preparation , either a compound or composition. They will in most cases also disclose the application of said compound or composition . Other patents in this category is the method of identifying novel molecules , methods of treatment , screening or diagnostic method . These patents also include different methods of testing. 6) The use or application
The focus of such patents is the effect of the compound or composition in a human body or other issues, such as treatment and prevention of specific diseases) 7) Delivery of drugs These patents give substantive information or any method or device or system for the delivery of drugs into the human body . Includes both the administration of drugs in general and the drug delivery system or method . 7) Devices Includes patents that describe any device, apparatus, equipment or system sometimes for drug delivery, manufacturing , surveillance , detection or diagnosis of particular drug and its activity . Conclusion It is a myth among analyst Pat , reading and understanding of the patent is resistant carpet . True, but if you have a clear understanding of the different types of patents, drug formulations and basic terminology used in pharmaceutical patents , which will make life easy. A careful reading of patent applications to identify the novelty and inventive step , along with the title and the summary can provide high-level information about a patent . Mahendra Chemicals is an US FDA approved ISO 9001:2008 certified Lidocaine Drug and pharmaceutical manufacturer.