Enantia at ALBA Synchrotron workshop

Enantia at ALBA Synchrotron workshop

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Front page ALBA meeting

Enantia at the ALBA Synchrotron workshop

June 15th, 2022

Next June 17th the ALBA Synchrotron will host the workshop: “ALBA Synchrotron Applications for the Pharmaceutical Industry” to show pharmaceutical companies the applications of synchrotron light. Studies at the synchrotron are a valuable ally for the pharmaceutical sector, for example, during the design of new drugs or the characterization of active ingredients in the final formulation.

The conference is aimed at managers and members of the R&D&i team from pharmaceutical and biomedical companies who wish to know more about how a synchrotron works and its main industrial applications.

Enantia is a frequent user of the ALBA synchrotron which has allowed us to build a solid experience exploiting its high sensitivity X-ray beam lines. We leverage our expertise to, for example, detect and quantify very small percentages of crystalline forms in complex matrixes including drug formulations, to determine the absolute configuration of an API and to confirm the formation of a cocrystal or a salt. Experiments performed by Enantia at the ALBA synchrotron are also used to support IP Hatch-Waxman Act litigation strategies both by plaintiff and defendant parties in Paragraph IV trials.

During the meeting, experienced staff from companies will present case studies involving the use of the ALBA synchrotron X-ray beam lines. Joan Farran, the head of Enantia’s Solid-State Analysis department, will be talking on behalf of Enantia about real examples of X-ray diffraction analysis that allowed advances in various stages of the development of pharmaceuticals products.

The event will also include a visit to the facilities as well as a networking lunch.

Attendance is free but registration is required through this website: https://indico.cells.es/e/workshopindustrialsalud

The event is organised in collaboration with BIOCAT and with the support of the European project LEAPS-Innov.

Enantia co-organises the 2022 SEQT Summer School

Enantia co-organises the 2022 SEQT Summer School

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Home > News > Enantia co-organises the 2022 SEQT summer school

SEQT_PCB_2022

Enantia co-organises the 2022 SEQT Summer School on medicinal chemistry and chemical biology in drug discovery

May 18th, 2022

We are pleased to share our consolidated expertise in drug discovery with young and passionate scientists by co-organising, along with the Spanish Society of Medicinal Chemistry (SEQT), the Seventh SEQT Summer School, which this year has been certified by the European Federation for Medicinal Chemistry and Chemical Biology (EFMC).

The event will take place next July 19-21th 2022 in the Barcelona Science Park and it brings a great opportunity for approaching the pharma industry to young researchers working in the field of chemistry and life sciences. The participants will learn about the state of the art and new trends in drug discovery and development with experts from Almirall, Novartis, Merck, Janssen, FAES Farma, Gate2Brain and Enantia, amongst others.

To facilitate an optimal interaction with the speakers, the number of attendees is limited, therefore early registrations are strongly encouraged. The deadline for registrations is on the 15/06/22.

 

 

New HPAPIs facilities

New HPAPIs facilities

Home > News > New HPAPIs facilities
XRPD HPAPI

Enantia extends its service portfolio to HPAPIs

March 28th, 2022

Enantia is proud to announce the commission of new dedicated facilities to work with HPAPIs in solid forms R&D projects.

High potency active pharmaceutical ingredients (HPAPIs) exert their activity at a very low dosage. Though the definition of a HPAPI is yet to be harmonized[1], HPAPIs can be defined based on the therapeutic dose as a pharmacologically-active ingredient with biological activity at approximately 15 μg/kg of body weight or below in humans, or a daily dose of 1 mg/day or below[2].

The global market of HPAPIs is forecasted to grow from 21.2 USD billions in 2021 to 32.17 USD billions in 2026 at an annual increase of 8.7%[3]. Within this category of compounds, the generic drug segment is the one expected to be the fastest growing[4]. Some of the factors attributing to its growth are patent expiry of HPAPI branded drugs and the rising number of patients in developing economies.

Therefore, undertaking a solid form screening to develop a new, non-infringing alternative solid form of a HPAPI can be a highly convenient strategy when aiming at developing new generics, as well as to extend IP rights for new chemical entities (NCE).

Hence, screening for new cocrystals, polymorphs, solvates and salts is a powerful tool that allows to competitively market new forms of a drug. In this sense, FDA[5] and EMA’s[6]  regulatory guidelines have set a clear and simple path to the filing of both NDA and ANDA using cocrystals as the solid form of the API.

Enantia’s new facilities allow working with HPAPIs having Operational Exposure Limits (OEL) down to 100 ng/m3, which comprises the overwhelming majority of HPAPIs. Moreover, an additional new X-ray powder diffractometer, working both in transmission and reflection mode, has been installed specifically for HPAPIs analysis.

This means that Enantia also offers for high potency APIs its expertise in:

Moreover, Enantia plans to soon extend all the necessary containment equipment and procedures to the Chemical R&D and Medicinal Chemistry departments in order to execute projects also involving HPAPIs.

If you want to know more about solid state R&D services for HPAPIs keep reading here.

_________________________________________________________

[1] Walsh, Andrew & Barle, Ester. (2017). Are high potency active pharmaceutical ingredients (HPAPI) also high risks for cross-contamination? Chemistry Today. 35.

[2] NTP1104. Industria farmacéutica: clasificación de principios activos en categorías. Actualiza NTP798.

[3] Global HPAPI Market Size, Share, Trends, COVID-19 Impact & Growth Analysis Report – Segmented By Type (Innovative HPAPI’s & Generic HPAPI’s), Synthesis (Biotech HPAPI’s & Synthetic HPAPI’s), Therapeutic Application & Region – Industry Forecast (2022 to 2027), January, 2022, ID: 2903, Pages: 175.

[4] High Potency Active Pharmaceutical Ingredients Market Size, Share & Trends Analysis Report By Product (Synthetic, Biotech), By Manufacturer Type (In-house, Outsourced), By Drug Type, By Application, By Region, And Segment Forecasts, 2021 – 2028. Published Date: Sep, 2021, Report ID: 978-1-68038-563-2, Number of Pages: 140.

[5] Regulatory Classification of Pharmaceutical Co-Crystals Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) February 2018 Pharmaceutical Quality/CMC Revision 1.

[6] Reflection paper on the use of cocrystals of active substances in medicinal products EMA/CHMP/CVMP/QWP/284008/2015.

Picture: Enantia’s HPAPIs dedicated XRPD working in transmission and reflection modes

New Cocrystal Discovered at Enantia Approved by the FDA

New Cocrystal Discovered at Enantia Approved by the FDA

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Home > News >New Cocrystal Discovery at Enantia Approved by the FDA

Asymmetric unit of the cocrystal of tramadol hydrochloride and celecoxib

New cocrystal discovered at Enantia approved by the FDA

February 14th, 2022

A new API-API pharmaceutical cocrystal discovered at Enantia for ESTEVE Pharmaceuticals and commercialised with the name of SEGLENTIS® has been recently approved by the FDA for its use in the United States.

The U.S. Federal Food & Drug Administration (FDA) has recently approved SEGLENTIS® (October 15th, 2021) for its use as acute pain treatment in adults. This new drug is an innovative API-API pharmaceutical cocrystal composed of two already commercial analgesics. Celecoxib and racemic tramadol hydrochloride are presented in a 1:1 stoichiometric ratio cocrystal and formulated as a tablet.

The discovery and development of this novel cocrystal has been carried out at ENANTIA for ESTEVE Pharmaceuticals. The drug has been licensed to KOWA Pharmaceuticals America Inc. for its commercialization in the United States, with a launch planned for this year 2022.

This announcement highlights the increasing relevance of the cocrystallization technology as an effective strategy for the design of new drugs. The improvement of some key physicochemical and pharmacokinetic properties of an API can be achieved through the obtention of a new solid form such as a cocrystal. Because of this, and the generation of new IP that cocrystals allow, pharmaceutical companies resort to this approach to launch new drugs and to manage the lifecycle of existing ones.

Both USA (FDA) and European (EMA) regulatory agencies have published their current guidance on the regulatory aspects of the use of pharmaceutical cocrystals in drugs. These guidelines strengthen the use of pharmaceutical cocrystals for drug development. In this sense, SEGLENTIS® adds to the list of already approved pharmaceutical cocrystals being ENTRESTO®, developed by NOVARTIS and approved by the FDA and the EMA in 2015, one of the first API-API cocrystals to reach the market.

The approval of SEGLENTIS® is fantastic news for the pharma industry in general and for the R&D companies specialised on new solid form development, in particular. ENANTIA has been one of the introducers of cocrystals and the study of their application in different fields such as pharma and nutraceutical products, as well as in chemical process development. This drug approval evidences ENANTIA’s expertise on cocrystal engineering gained over almost 20 years since its foundation, demonstrated by the appearance of Enantia in more than 25 patent applications related to the study of cocrystals either as applicant or as inventor.

If you want to learn more about cocrystals, keep reading here.

 

 

Picture: Asymmetric unit of the APIAPI cocrystal formed by tramadol·HCl and celecoxib. https://doi.org/10.1021/acs.cgd.6b01848

We wish you all Merry Christmas and a happy and healthy 2022!

We wish you all Merry Christmas and a happy and healthy 2022!

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Home > News > Christmas 2021 at Enantia

Christmas tree with Enantia's logo

We wish you all Merry Christmas and a happy and healthy 2022!

December 17th, 2021

From Enantia we wish you all good health, joy and prosperity throughout the coming year 2022.

We would like to thank our customers, suppliers and employees for your continued support and partnership. We look forward to working with you in the years to come.

Enantia receives an Expoquimia Award

Enantia receives an Expoquimia Award

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Enantia receives an Expoquimia Award for its work in co-crystallization technology to pufity cannabidiol

Enantia receives one of the Expoquimia Awards 2020 for the use of co-crystallization technology for the purification of CBD from plant extracts.

September 17th, 2021

Enantia has received one of the awards from the sixth edition of the Expoquimia Awards 2020 for Research, Development and Innovation in the field of chemistry.

This award recognizes the most innovative processes and the most sustainable products and chemical technologies. Enantia participated with its work in cannabinoids named “Co-crystals fish out cannabinoid from plant extract”, which highlights the potential of Enantia’s technology to develop efficient processes for the purification of cannabidiol (CBD) from natural sources and, in general, for the purification of high-value compounds from complex matrixes of either natural or synthetic origins. You can read more about this technology here.

We would like to thank the committee for this recognition, and congratulate the rest of the participants.

 

Picture: Dr. Sara Preciado (Head of IP and Innovation at Enantia) receiving the award at the Expoquimia 2021 event.

Enantia sponsors one of the Young Researchers’ Awards of the XX SEQT Congress

Enantia sponsors one of the Young Researchers’ Awards of the XX SEQT Congress

 

Home > News > Enantia sponsors one of the Young Researchers’ Awards of the XX SEQT Congress

Enantia sponsors one of the Young Researchers' Awards of the XX SEQT Congress

Enantia sponsors one of the Young Researchers’ Awards of the XX SEQT Congress

 

July 12th, 2021

It’s a pleasure to announce Enantia’s collaboration with the SEQT on their XX Awards, which will be given on the XX Congress of the SEQT. The meeting will be held in Santiago de Compostela from January 23th to 26th, 2022. Are you an early career researcher in the field of search and development of new drugs? Call is open until the 15th of July, look here for details and submit your work!

The Spanish Society of Medicinal Chemistry (SEQT) is a multidisciplinary, non-profit body created in 1977. It integrates all professionals, companies, and organizations whose activity is related to Spanish Pharmaceutical R+D. The goals of the SEQT are to promote the development of this field through the organization of scientific meetings that will stimulate professional contacts at both national and international levels, and to contribute to the training of advanced graduate students in the field. The SEQT is member of the European Federation for Medicinal Chemistry (EFMC), which groups the majority of graduates and professionals working in Pharmaceutical R+D.

Renewal of Enantia’s ISO 9001:2015 Certificate

Renewal of Enantia’s ISO 9001:2015 Certificate

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ISO 9001:2015 Certificate

Renewal of ISO 9001:2015 Certificate

July 7th, 2021

Our UNE-EN ISO 9001:2015 certificate has been renewed for our services in development and synthesis of organic compounds, as well as for the development, preparation and analysis of solid forms. This demonstrates, once again, Enantia’s high-quality standards to meet our customer’s requirements.

At Enantia we also undertake projects that require Good Manufacturing Practice (GMP) Certification that involve the synthesis of drug candidates and active pharmaceutical ingredients, as well as the preparation of solid forms like cocrystals, salts, polymorphs and solvates of a given compound, delivered by our trusted GMP-certified partners.

 

Enantia’s Spray Dryer

Enantia’s Spray Dryer

 

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Enantia at CPhI

Enantia’s Spray Dryer

 

May 27th, 2021

Enantia broadens its services by offering amorphous solids development services by using a Büchi Mini Spray Dryer B-290, which allows working with active compounds and excipients using aqueous and organic solvents.

Spray drying is a reliable and scalable technique to develop and manufacture amorphous solids and particles in the desired size distribution, which we do as part of our solid state services. In particular, the Büchi Mini Spray Dryer B-290 is ideal for research and development projects as only quantities in the range of grams of the targeted compound are required, but can also produce hundreds of grams. Additionally, the processes developed with this equipment can be easily scaled up to an industrial batch size.

Enantia’s spray dryer is very versatile allowing the use of solutions, emulsions and suspensions in both aqueous and organic solvents. The desired particles are quickly produced using a reproducible, low impact process.

Nowadays the pharmaceutical, nutraceutical and cosmetic industries are widely using spray drying to obtain:

  • Reproducible amorphization of solids, including APIs, to:
    • Increase bioavailability (by increasing API’s solubility)
    • Find non IP infringing solid forms
    • Produce particles with the right particle size distribution to be used in inhaled administration
  • Improved API solid forms for controlled release formulations, flavour masking and better handling of oils by microencapsulation and polymer dispersion

Enantia at CPhI Discover 2021

Enantia at CPhI Discover 2021

 

Home > News > Enantia at CPhI Discover 2021

Enantia at CPhI

Enantia at CPhI Discover 2021

 

May 21st, 2021

Enantia is attending the current edition of CPhI Discover taking place online from the 17th to the 28th  of May.

We will be glad to meet you to discuss more about our Process Chemistry services, including route scouting, CMC support and scale up with our new kilo lab facilities. We also offer Medicinal Chemistry programs from hit finding to lead optimization, aside from other support activities.

Contact us also for our Solid Form Development services to optimize the properties of your candidates, improving their IP or to use our pioneering cocrystallization technology for an easy and scalable purification of complex crudes or natural extracts.

Additionally, we count with a Solid Form Analysis department for a detailed understanding of the solid phase in the development and manufacturing of APIs and fine chemicals.

Finally, we also offer pharmaceutical grade synthetic GMP CBD to be used in your clinical development programs.

You can find us during the CPhI as exhibitors and the rest of the year at info@enantia.com