WO2016072874A1 - Procédé de codage de formes solides pharmaceutiques au moyen d'un code d'authentification, un dispositif de codage de poudre en vrac et un processus de certification de produit - Google Patents

Procédé de codage de formes solides pharmaceutiques au moyen d'un code d'authentification, un dispositif de codage de poudre en vrac et un processus de certification de produit Download PDF

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Publication number
WO2016072874A1
WO2016072874A1 PCT/PT2014/000067 PT2014000067W WO2016072874A1 WO 2016072874 A1 WO2016072874 A1 WO 2016072874A1 PT 2014000067 W PT2014000067 W PT 2014000067W WO 2016072874 A1 WO2016072874 A1 WO 2016072874A1
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WO
WIPO (PCT)
Prior art keywords
codification
markers
pharmaceutical
product
solid pharmaceutical
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PCT/PT2014/000067
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English (en)
Inventor
Fernando Miguel Da Silva CRUZ
Original Assignee
Fernando Cruz - Promoções Técnico Cientificas, Unipessoal Lda
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Application filed by Fernando Cruz - Promoções Técnico Cientificas, Unipessoal Lda filed Critical Fernando Cruz - Promoções Técnico Cientificas, Unipessoal Lda
Priority to PCT/PT2014/000067 priority Critical patent/WO2016072874A1/fr
Publication of WO2016072874A1 publication Critical patent/WO2016072874A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/3563—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light for analysing solids; Preparation of samples therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/007—Marking tablets or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means

Definitions

  • the present invention relates to the codification of pharmaceutical products, more precisely solid pharmaceutical forms, by means of an authentication code to certificate and verify the authenticity and the origin of these products in a traceability process.
  • the present invention relates to a method for codification of solid pharmaceutical forms, the solid pharmaceutical forms thus codified and a device for encoding such codified solid pharmaceutical forms.
  • the present invention also relates to the process of certification and verification of the authenticity and the origin of codified solid pharmaceutical forms and the detection of counterfeit or imitated or falsified or adulterated products, along the supply chain of such products.
  • the certification of authenticity of pharmaceutical dosage forms and other health products along the supply chain has been an urgent task to combat counterfeiting and to control geographic distribution of these products, from manufacture to acquisition by the consumers.
  • the certification of authenticity is substantial to guarantee the consumers safety and is necessary to take measures to improve the control of counterfeiting and create a traceability method to follow the geographic distribution of such products.
  • counterfeit or falsified products it may include the original pharmaceutical products, branded ones or generic ones.
  • counterfeiters copy or imitate the drug, in other cases the drug may not have the active pharmaceutical ingredient or may own a harmful or improper product.
  • An authentic packaging doesn't necessarily correspond to authentic contents.
  • the traceability systems include both hardware (identification tags, printers and scanners) and software components (ePedigree, serialization and track-and- trace).
  • the RFID technology prevail over the barcodes due to its advantage in speed, range and storage capacity, as well as its unique ability to scan multiple items at once from any orientation. All of these technologies are paper-based and dependent of product's package quality level. They assure the traceability of the package but not of the product itself. They don't protect against sophisticated repacking of counterfeit product in certified packaging.
  • the invention 2007/016374 A2 (WILDEY, C et al) (08.02.2007) is an apparatus and method for security tag detection, that uses luminescence properties from different compounds to print diverse optical signatures in security tags at the packaging, avoiding counterfeit products.
  • the NIR techniques may be used to determine the homogeneity of a batch and to screen for the presence of the active pharmaceutical ingredients (API) despite standard analytical methods still being necessary for definitive confirmation.
  • the present invention comprises an infrared spectroscopy analysis, although the method here disclosed is not limited to screen the presence or the absence of the API.
  • the present invention allows for the screening of codified pharmaceutical forms, through a method of codification wherein small amounts of codification markers were added during the manufacturing process of the pharmaceutical forms, aiming to produce a unique and unambiguous spectrum that will function as a product signature.
  • the US patent application 2007/0219916A1 discloses a system to print alphanumeric codes in pharmaceutical products in order to identify their origin in the pharmaceutical supply chain.
  • the US patent application 2007/0160814A1 (MERCOLINO, T. J.) describes a method to identify coated tablets by a signature array, through the incorporation of a great number of different substances in the coating film of tablets.
  • the US patent application 2013/084249 A1 (LAWANDY; Nabil M.) presents authenticate coatings for pharmaceutical tablets and ingestible materials by using spherical particles stacked in the coating film of tablets. The coatings are formed from a lattice of particles stacked to cause selective diffraction, creating an optical signature. Then the signature is associated to each coating that can be read and authenticated.
  • inactive ingredients are also a critical factor for mass production of drugs during its industrial manufacture, because not all inactive ingredients can be significantly altered.
  • inactive ingredients can be significantly altered in order to create a substantial impact on the infrared spectrum.
  • small variations in the inactive ingredient that are present at low concentration in the product formulation can also be critical for the manufacturing process and do not cause substantial impact on the infrared spectrum.
  • a great need for an adequate invention that assures the authentication of such pharmaceutical forms still exists.
  • the invention here disclosed presents a high level of security, quick and easy application to products, guarantee of authentication, difficult to adulterate and reply, automated, simple to be used by the consumers in the industry and legally accepted by regulatory authorities.
  • the present invention overcomes the already known solutions: keeping unchanged and not destroying the original formula of the product; not causing manufacturing problems during the addition of the small amounts of the codification markers used to produce endless and distinctive infrared spectra; allowing codification of solid pharmaceutical forms without infringement of manufacturing process and the quality of the final product.
  • the invention solves the mentioned problems through a method for codification of solid pharmaceutical forms with an exclusive and unequivocal authenticity code, a bulk powder encoding device and a process of certification. Besides, it keeps the unit weight of the pharmaceutical form constant and does not affect the validation of the industrial manufacturing process
  • the present invention comprises spectral analysis, more precisely infrared spectroscopy (IR), to detect specific spectral variances in IR spectrum obtained from solid pharmaceutical forms, and creating a code which functions as a product signature.
  • IR infrared spectroscopy
  • Those spectral variances are obtained after adding small amounts of codification markers to the pharmaceutical powders mixture, they function like a code which produce modifications in the product infrared spectra which allows the authentication of solid pharmaceutical forms throughout the supply chain until the end user.
  • the method for codification of solid pharmaceutical forms comprises some steps. It requires the addition of different combinations of small amounts of codification markers, particularly pharmaceutical grade markers, to the pharmaceutical mixture of powders during the manufacture process.
  • the final mixture will correspond to the pharmaceutical product to be codified and to be authenticated.
  • the combinations and ranges of concentration of the codification powder markers to be adding to the final mixture will generate a unique infrared spectrum detectable through infrared spectroscopy device.
  • the association of that spectrum to a set of manufacturing data such as batch number, manufacture date and location or expiration date, will allow identifying any solid pharmaceutical form manufactured by this method, such as tablets, capsules or powders in sachets.
  • the method for the codification of solid pharmaceutical forms requires a bulk powder encoding device.
  • This bulk powder encoding device is responsible to add to the powder mixture small and accurate amounts of pharmaceutical-grade powder markers.
  • the amounts of each powder marker must differ between which one for every pharmaceutical form being produced.
  • this method for codification requires determining the combination of markers and ranges of concentration of one, or more, codification markers to be applied on a solid pharmaceutical form, which may not be present in the original recipe of the pharmaceutical product.
  • the combination of markers and the concentration ranges of the codified markers must make at least one intense and distinct spectrum band in infrared spectra. This is crucial to confirm if the infrared spectrum is exclusive and unequivocal for that product. If the result of the infrared spectrum is not exclusive or unequivocal for that product the process is repeated and a new addition with other amounts/concentrations of the codification markers is performed, until an exclusive and unequivocal infrared spectrum is in fact obtained.
  • the process of manufacture of solid pharmaceutical form continues.
  • This codification is made by a bulk powder encoding device suited into an industrial powder blender.
  • This device is required for the accurate addition of codification powder markers into the pharmaceutical mixture of powders blended during the manufacturing.
  • the present invention allows the possibility to associate a set of manufacturing information, such as batch number, manufacture date, manufacture location, expiration date, dosage of pharmaceutically active ingredient (API), brand and other details, to the infrared spectrum.
  • FT-NIR Fourier transform infrared spectroscopy
  • Figure 1 is a diagrammatic representation of a cross section of a depot (1 ), from a bulk powder encoding device.
  • the codification marker (3) is stored inside the depot of the bulk powder encoding device (2).
  • the depot (1 ) has an opening (4) to introduce the codification marker, and integrates the bulk powder encoding excipient device assembled in the cover of an industrial powder blender (5).
  • a wireless controller (6) connected to a database via radio frequency is represented here, from where it receives data containing information about combinations of amounts of codification markers to be added to the industrial bulk powder blend.
  • the controller also transmits back to the database the data related to the infrared spectra obtained from the pharmaceutical mixture of powders manufactured after the addition of codification markers.
  • the addition of the codification marker (3) to the powders mixture blended (7) inside the industrial powder mixture (8) is made by an accurate dosing system (9) connected with the dispenser (10) responsible for introducing the accurate amount of codification markers to the powder mixture blended.
  • Figure 2 is a diagrammatic representation of side perspective view of a bulk powder encoding device suited over the cover of an industrial powder blender.
  • a wireless controller (6) receives
  • the infrared probes (7) are installed on the walls of the industrial powders blender, in order to gather spectral information from the pharmaceutical powders blend.
  • FIG. 3 is a diagrammatic exploded perspective from the top of preferred embodiment of the bulk powder encoding excipient over the cover of an industrial powder blender.
  • the industrial powder blender is used to blend the excipients and the active pharmaceutical drugs during the manufacturing process of solid pharmaceutical forms.
  • a bulk encoded device with a plurality of depots is represented on the top of the industrial powder blender, wherein this preferred embodiment six depots (1) are used to store the codification powder markers; openings (11 ) for recharging and dosing codification powder markers to the inside of the industrial powder blender; an orifice for the dispenser tube (12) wherein the codification marker is added inside the industrial powder blender; a dispenser (10) for the accurate addition of codification markers to the blended mixture inside the industrial powder blender; a wireless controller (6) that receives data from the database, containing information about combinations of amounts of codification markers to be added to the industrial bulk powder blend, and also transmits back to the database, the data related to the infrared spectra obtained from the pharmaceutical mixture of powders manufactured after the addition
  • Figure 4 is a diagrammatic exploded perspective of the bulk powder encoding device, suited over the cover of an industrial powder blender.
  • Figure 5 is the spectrum obtained for Diffuse Reflectance Infrared Fourier transform spectroscopy (DRIFTS) of a commercial premix of excipients ready to produce a solid pharmaceutical form Prosolv EasyTab® (PS), with 3 different amounts and combinations of pharmaceutical-grade markers (AM9, AM10 and AM11 ).
  • DRIFTS Diffuse Reflectance Infrared Fourier transform spectroscopy
  • PS Prosolv EasyTab®
  • AM9, AM10 and AM11 3 different amounts and combinations of pharmaceutical-grade markers
  • FIG. 6 is the spectrum obtained for Diffuse Reflectance Infrared Fourier transform spectroscopy (DRIFTS) of commercial premix of excipients Prosolv EasyTab® (PS), with 3 (three) different amounts and combinations of pharmaceutical-grade markers (AM9, AM10 and AM1 1 ) using an amplification of the region between 1800-850 cm "1 , with spectra normalization at -1045 cm -1 .
  • DRIFTS Diffuse Reflectance Infrared Fourier transform spectroscopy
  • “Pharmaceutical product” is a solid pharmaceutical form, considering a dosage form that comprises one or more active pharmaceutical ingredient (API) - biologic, synthetic or nutraceutical - and one or more inactive ingredients, in particular pharmaceutical excipients.
  • API active pharmaceutical ingredient
  • “Pharmaceutical form” is any group of pharmaceutical substances whose aim is to deliver one or more than one API, by any way of administration, such as in the form of tablets, hard capsules or powders sachets.
  • “Pharmaceutical-grade marker” considers an excipient communally used in the pharmaceutical industry and in the case of the present invention is able to cause a modification of the infrared spectrum of the pharmaceutical form being codified.
  • “Excipient” is a regulatory approved pharmaceutical substance, or composition of substances, without pharmacological activity and suitable to be including in the pharmaceutical dosage form.
  • Counterfeit denotes a product that has been mislabeled or otherwise adulterated with respect to identify and/or source. A product manufactured by an unapproved source is counterfeit.
  • Counterfeit pharmaceutical product or “counterfeit product” are terms indicating faked, adulterated or mislabeled medicines or products from the real/original product. It can be also a manufactured and/or commercialized product without the supervision and authorization of Regulatory authorities, and which do not comprise properly the therapeutic API.
  • Product signature is infrared spectrum of a pharmaceutical product after the addition of different amounts and combinations of codification markers, in order to obtain an exclusive and unequivocal infrared spectrum.
  • the present invention discloses a method for codification of solid pharmaceutical forms comprising the follow steps:
  • step e Using the exclusive and unequivocal infrared spectrum of the solid pharmaceutical form as the product signature, associating said signature with the manufacturing data mentioned in step e), and storing it in a database.
  • the databases used are information systems that store and manage information, namely the association between the obtained spectrum and respective manufacturing product data.
  • the databases are crucial to guarantee the process of certification and verification of the authenticity of the pharmaceutical forms along the whole supply chain by comparing the spectra obtained from the product with the respective manufacturing information existing in the database.
  • the aim of the disclosed method is obtaining an exclusive and unequivocal spectrum from the pharmaceutical solid form as a product signature used in the authentication process for a pharmaceutical form along the supply chain from the manufacturing to the commercialization of such products.
  • the pharmaceutical forms correspond to a mixture of one or more than one API and excipients.
  • the API are all compounds that are classified as such by the Regulatory authorities, and that can be used with excipients on the formulation of solid pharmaceutical forms such as tablets, capsules or powder in sachets.
  • Prosolv EasyTab® is a commercial premix of excipients that represents a typical industrial mixture of excipients.
  • the codification markers are excipients suitable to be included in the pharmaceutical dosage forms, more precisely solid pharmaceutical forms.
  • the method for the production of a codified solid pharmaceutical form also considers a step consisting in the association of the obtained infrared spectrum with a set of information related manufacturing data. Then the data is stored in a database.
  • the codification markers employed for the present invention may be selected between every pharmaceutical-grade compound that produces, isolated or in combination, an infrared spectral band distinct from the original pharmaceutical form.
  • the codification markers are selected among pharmaceutical-grade pigments, isolated or in combination.
  • Some pharmaceutical-grade pigments that may embody the present invention are erythrosine and/or tartrazine. However other dye pigments may be applied.
  • the concentration of the codification markers should be lower than 1.0%, preferentially between 0.1 % and 1.0% of the weight of the solid pharmaceutical form, and more preferentially between 0.2% and 1.0% of the weight of the solid pharmaceutical form. This represents a minimal percentage weight variation in the final formulation and does not change or influence the manufacturing process of the pharmaceutical form, whether it is a tablet, a hard capsule or a powder in sachets.
  • a spectroscopy reading device More precisely a diffuse reflectance infrared Fourier transform (DRIFT), that is capable to obtain the infrared product signature from a powder mixture.
  • DRIFT diffuse reflectance infrared Fourier transform
  • the present invention discloses an obtained codified pharmaceutical form, based on the method for codification described before.
  • the present invention discloses a bulk powder encoding device, for coding solid pharmaceutical forms, which is suited to an industrial powder blender.
  • This bulk powder encoding device comprises the following features:
  • a plurality of dispensers for codification markers each one containing a worm gear, for the accurate addition of codification powder markers inside of the industrial blender, and according to the codification codes designated by a database;
  • a plurality of dosing tubes which accommodates inside an accurate powder dosing system. This system contacts, at one end, with the codification markers, and in the opposite end with the interior of the industrial powder blender;
  • a wireless controller that receives radio frequency data from the database, containing information about combinations of amounts and combinations of codification markers to be added to the industrial bulk powder blend, and also transmits back to the database, the data related to the infrared spectra obtained from the pharmaceutical mixture of powders manufactured after the addition of codification markers. It commands the introduction of codification markers, according to the data received from the database;
  • the number of external depots, dispensers and dosing tubes vary according the number of different codification markers desired to introduce. Using only two codification markers is already sufficient to produce a number of combinations and spectra modifications, sufficient to codify a pharmaceutical product, as it is disclosed in the examples of the invention.
  • a preferred configuration of the bulk powder encoding device comprises six external depots, dispensers and dosing tubes, in order to apply six different codification markers.
  • any conventional industrial power blender available in the market can be used for the manufacturing process of pharmaceutical forms, for blending the excipients and the API.
  • the present invention instead of presenting a method of certification for packaging, labels, signatures, watermarks or other extrinsic/superficial marks of pharmaceutical products, it considers process of certification for the own pharmaceutical forms. It takes advantages on the fact that small amounts of codification markers added to the producing powder mixture produce a unique infrared spectrum, used to codifying pharmaceutical forms. Hence, the present invention is not an identification or reading process, but a method of codification based on the modifications produced on the infrared spectrum of a solid pharmaceutical form.
  • the presented invention discloses a unique and unambiguous process of certification and verification of the authenticity and origin of codified solid pharmaceutical forms, and without damaging the product.
  • the process of certification and verification of the authenticity and origin comprises the follow steps:
  • the present invention guarantees the traceability of the pharmaceutical form itself and not the packaging, even in case of repackaging. This improves the process of detecting counterfeit products, thus unmasking counterfeiting products placed inside certified packaging. In these cases the IR spectrum obtained from the pharmaceutical form does not match the information stored in a database.
  • the proposed method differentiates from other existing methods by not requiring the preparation nor destruction of the pharmaceutical forms samples, neither requiring the application of subsequent analysis to confirm the results, a step required, for example, in standard analytical methods.
  • the present invention comprises small additions of codification markers and proportional deductions on the excipients amount, thus maintaining the unitary weight of the pharmaceutical form.
  • the deduction is performed on the excipient presented in greater proportions, usually the diluent, for example microcrystalline cellulose.
  • the codification markers are selected from any pharmaceutical-grade compounds that change the infrared spectrum, preferentially in regions of the spectrum distinct from other components that integrate the pharmaceutical form.
  • the codification markers are preferably selected between pharmaceutical-grade dyes, as for example erythrosine or atrazine. They can also be used in either an isolated or combined way.
  • All information related to the manufacturing process is sent to the database or a library database via internet, and may be shared between different users of this invention along the supply chain (pharmaceutical property owners, producers, distributors, regulatory authorities, pharmacies).
  • the powder mixtures were prepared by blending the Prosolv EasyTab® (PS) as an example of a typical pharmaceutical powder blend with pharmaceutical-grade markers ER and TZ.
  • the AM9 mixture was prepared according to the following concentrations, in percentage by weight:
  • KBr Pyrolidone
  • DRIFTS Diffuse Reflectance Infrared Transform Spectroscopy
  • the powder mixture AM9 was characterized by DRIFTS analysis, in medium infrared spectral region between (4000-400 cm-1 ), first by DRIFTS with spectra normalization at 2900 cm-1.
  • the unique/visible band was almost exclusively due to the Prosolv EasyTab® (PS) matrix.
  • the spectral region was amplified between 1800-850 cm-1 , with a spectra normalization at -1045 cm-1.
  • the obtained analysis can be verified in Figure 5 and Figure 6, respectively.
  • Example 2 Preparing a powder mixture designated as AM10
  • the powder mixture designated as AM 10 was produced similarly to Example 1 of the invention. However, the amounts and concentrations of pharmaceutical-grade premix excipient, PS, and the pharmaceutical-grade markers, ER and TZ, were modified, according to the following concentrations, in percentage by weight:
  • the powder mixture designated as AM1 1 was produced similarly to Example 1 of the invention. However, the amounts and concentrations of pharmaceutical-grade excipient, PS, and the pharmaceutical-grade markers, ER and TZ, were modified, according to the following concentrations, in percentage by weight:
  • FIG. 5 and Figure 6 represent graphs of the infrared spectra obtained for the three demonstrative mixtures aiming to illustrate the presented invention. It proves that different amounts of codification markers (ER and TZ) produce exclusive and unequivocal infrared spectrum in a typical pharmaceutical powder blend (PS) for which powder mixture exemplified (AM9, AM10 e AM11 ).
  • PS typical pharmaceutical powder blend
  • the codification markers used, ER and TZ present different spectral regions, with distinct maximum of absorption (respectively 1700-1300 cm-1 and 900-500 cm-1 ).
  • the Prosolv EasyTab® presents wide spectrum bands. However, there are two regions, between -1650-1490 and -880-790 cm “1 , without matrix bands, where the vibrational modes of the employed codification markers can be observed.
  • Example 1 and Example 3 it is clear the existence of a spectral region that can be considered as a signature for each composition (the product signature), when the Prosolv EasyTab® was inferior to 99.6% and the codification markers were superior to 0.4% of the percentage by weight.
  • the invention here disclosed is object of several variations and modifications, all of them within the scope of protection in the claims presented. Furthermore, all details or technical specificities can be replaced by other technically equivalent elements.
  • An expert in the area understands that the present invention may be adapted to other suitable codification markers and other industrial powder blends without reconsidering the scope of the invention.
  • the pharmaceutical compounds or pharmaceutical-grade markers and its amounts or concentrations can vary, according to each replication of the invention. When some technical characteristic was mentioned in a claim and referenced according to some amount or range amount, these should be interpreted as a way to increase the intelligibility of the claims, and do not should be interpreted as a limiting effect on the interpretation of the claim.

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Abstract

La présente invention vise à détecter des produits pharmaceutiques contrefaits, ou imités, ou falsifiés, ou frelatés. L' invention concerne un procédé pour coder des formes pharmaceutiques solides, au moyen d'un code d'authentification afin de vérifier et de certifier l'authenticité et l'origine de tels produits, comprenant un dispositif de codage de poudre en vrac et un processus de certification de produit. Le procédé produit une signature de produit, sous la forme d'un spectre infrarouge (IR) unique et non ambigu, en ajoutant de petites quantités de marqueurs de qualité pharmaceutique dans chaque produit devant être certifié. Ces marqueurs pharmaceutiques sont ajoutés par l'intermédiaire d'un dispositif de codage en vrac disposée au-dessus d'une poudre de mélange industriel. Ensuite, le long de la chaîne d'approvisionnement, des dispositifs à infrarouges lisent le spectre des formes pharmaceutiques solides codifiées et les comparent avec des informations stockées dans des bases de données afin de garantir la véracité de l'information affichée dans l'emballage respectif. Il associe également un ensemble de données de fabrication, telles que le numéro de lot, la date de fabrication, le site de fabrication, la date d'expiration, la dose de principe pharmaceutiquement actif (API), et la marque pour chaque spectre infrarouge/signature de produit. Cette invention est appliquée à des formes pharmaceutiques solides telles que des comprimés, des capsules et des sachets de poudre et le long de toute la chaîne d'approvisionnement du produit pharmaceutique.
PCT/PT2014/000067 2014-11-07 2014-11-07 Procédé de codage de formes solides pharmaceutiques au moyen d'un code d'authentification, un dispositif de codage de poudre en vrac et un processus de certification de produit WO2016072874A1 (fr)

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US20070012784A1 (en) * 2005-06-20 2007-01-18 Mercolino Thomas J Product authentication
WO2007016374A2 (fr) 2005-07-29 2007-02-08 Authentix, Inc. Appareil et procede pour la detection d'etiquettes de securite
US20070086625A1 (en) 2003-09-22 2007-04-19 University Of Maryland, Baltimore Drug authentication
US20070160814A1 (en) 2005-06-20 2007-07-12 Mercolino Thomas J Methods for quality control
US20070219916A1 (en) 2000-03-07 2007-09-20 Michael Lucas Systems and methods for tracking and verifying the authenticity of an item
US20120300201A1 (en) 2011-05-27 2012-11-29 Kaiser Optical Systems Large-collection-area raman probe with reduced background fluorescence
US20130084249A1 (en) 2011-09-29 2013-04-04 Spectra Systems Corporation Authenticatable coatings for pharmaceutical tablets and ingestible materials
US20140183362A1 (en) * 2012-12-31 2014-07-03 Omni Medsci, Inc. Short-wave infrared super-continuum lasers for detecting counterfeit or illicit drugs and pharmaceutical process control

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Publication number Priority date Publication date Assignee Title
US20070219916A1 (en) 2000-03-07 2007-09-20 Michael Lucas Systems and methods for tracking and verifying the authenticity of an item
US20070086625A1 (en) 2003-09-22 2007-04-19 University Of Maryland, Baltimore Drug authentication
US20070012784A1 (en) * 2005-06-20 2007-01-18 Mercolino Thomas J Product authentication
US20070160814A1 (en) 2005-06-20 2007-07-12 Mercolino Thomas J Methods for quality control
WO2007016374A2 (fr) 2005-07-29 2007-02-08 Authentix, Inc. Appareil et procede pour la detection d'etiquettes de securite
US20120300201A1 (en) 2011-05-27 2012-11-29 Kaiser Optical Systems Large-collection-area raman probe with reduced background fluorescence
US20130084249A1 (en) 2011-09-29 2013-04-04 Spectra Systems Corporation Authenticatable coatings for pharmaceutical tablets and ingestible materials
US20140183362A1 (en) * 2012-12-31 2014-07-03 Omni Medsci, Inc. Short-wave infrared super-continuum lasers for detecting counterfeit or illicit drugs and pharmaceutical process control

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Title
DEISINGH, ANALYST, vol. 130, 2005, pages 271 - 279
SINGH, ANALYST, vol. 130, pages 271 - 279

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