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SARA Pharm Solutions

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SARA Pharm Solutions

SARA Pharm Solutions is a private Contract Research Organization (CRO) specialized in solid-state pharmaceutics, pre-formulation and first-steps into formulation services. The company is located in the heart of the Romanian capital, Bucharest, in a newly renovated complex, Electromagnetica Business Park.

Making use of modeling tools to identify the most suitable solvents and excipients

SARA Pharm Solutions offers a comprehensive menu of specialized services, taking the Active Pharmaceutical Ingredient (API) drug substance through the stages of generating the first crystals, identifying the best (crystalline) solid form via extensive polymorph, salt or co-crystal screening and developing a robust crystallization process.

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SARA Pharm Solutions designs scientifically strong programs based on years of working experience of its scientific team. In all of its solid form screening programs, SARA Pharm Solutions makes use of modeling tools to identify the most suitable solvents and excipients to be taken into consideration with the drug substance under investigation.

Screening a broad and diverse parameter space in a short space of time

As a general as well as pragmatic view on the screening programs, with a minimal amount of API, SARA Pharm Solutions can screen a broad and diverse parameter space in a short space of time. Tailored experimental designs and crystallization modes yield an impressive throughput of conditions and results reported in a week or two.

The standard programs offered by SARA Pharm Solutions include:

  • Polymorph, salt and co-crystal screening;
  • Production, quantification and stabilization of amorphous phases;
  • Amorphous solid dispersion screening;
  • Pre-formulation studies (e.g. determination of solubility, dissolution rate – function of pH, pKa and logP/D determinations);
  • Stability studies on the drug substance (e.g. solid-state and solution phase stability, excipient compatibility studies);
  • Crystallization studies, crystallization process development and scale-up (max. 30-50g API);
  • Advanced analytical studies including: High throughput-XRPD, DSC, TGA, HPLC, NMR, IR, Raman, PLM;
  • Drug substance and Drug product characterization for formulation development (e.g. characterization of the solid forms in drug products such as tablets, capsules, semi-solids, suspensions)

In its on-going commitment to excellence, SARA Pharm Solutions has invested in a state of the art processing equipment and supporting analytical capabilities with the aim to identify and create new and improved drugs via solid state research.

An extensive track record of innovation and research contributions

Sara’s management and technical team consists of both industrial and academic scientists with 5 decades of cumulative experience in US, Canada, UK and The Netherlands. They possess extensive track record of innovation and research contributions in solid state chemistry for pharma domain.

Sara’s Quality Management System (QMS) has been recognized to be in full compliance with ISO9001:2008 standards, following an external audit carried out by Germanischer Lloyd Systems Certification. Sara’s solid state studies are done according to and are in direct accordance with ICH Q8, 9 and 10 guidelines.

We will be happy to answer all your inquiries.

Contact

SARA Pharm Solutions S.R.L.
266-268 Calea Rahovei
Bucharest
Romania
RO-050912

Contact person:
Ioan Mihalcea – Chief Commercial Officer
Email: ioan.mihalcea@sara-pharm.com
Mobile:40-742.559.304
Tel: 40-312.28.3800;
Fax: 40-312.28.3802
www.sara-pharm.com

Amorphous Solid Dispersions (ASD) Screening Programs

As always, APIs with poor aqueous solubility have been a big problem in development of new drug products. One attractive solution is the use of an amorphous form of the drug substance. This is because amorphous phases are much more soluble than their crystalline counterparts, and can often be formulated to be physically and chemically stable throughout the shelf life of the drug product.

SARA PHARM has numerous techniques to search for and stabilize amorphous forms of drug substance, which is a strict requirement. ASDs are a good solution to be considered for carrying out the first animal tox studies to determine the maximum tolerated dose (MTD) when dealing with a poor soluble API. A rather limited amount of…

Analytical Development Programs

SARA PHARM offers a broad range of analytical services alongside with the screening programs.

A quick selection of available analytical techniques include as following:X-Ray Powder Diffraction (top-of-the-art equipment) (e.g crystalline form identification)Differential Scanning Calorimetry (DSC) (e.g melting point and other thermal transitions identification)Thermo-gravimetric Analysis (TGA) (e.g form nature identification: solvate, hydrate or anhydrate)Single Crystal (SC) analysis (e.g crystal structure determination)Nuclear Magnetic Resonance (NMR) investigations (e.g structural identification)Infra-red (IR) and…

Co-crystal Screening Programs

Co-crystallization, as a crystal-engineering technique, is generating a great interest in the pharmaceutical industry. Co-crystals incorporate pharmaceutically acceptable guest molecules into a crystal lattice along with the API, resulting mainly in renewed physico-chemical properties.

SARA PHARM's co-crystal screen is designed to identify new solid forms with enhanced physico-chemical property or bioavailability enabling in this way the development of improved versions of existing drug products. SARA PHARM can offer several levels of co-crystal screening to suit different research goals and budgets. In this particular case as well SARA PHARM is…

Crystallization & Process Optimization Programs

SARA PHARM offers specialized crystallization packages, targeted to transform your un-handable API, such as a sticky gum into a nice crystalline and fully handable powdery material. Using a tailored crystallization process design, SARA PHARM concentrates on the most acceptable pharmaceutical solvent systems (e.g Class# 3, conform ICH guidelines) for identification of a robust and easily scalable crystallization process.

Once having determined the solubility of your API in a set of predefined and chemically diverse set of solvents, SARA PHARM will identify the most suitable solvent systems to be considered for Meta-Stable Zone Width determination (MSZW), a crucial parameter for optimizing the crystallization process.SARA PHARM is able to consider in this program different crystallization…

Polymorph Screening Programs

Sara Pharm has screening services to accommodate different research needs and research budgets.  

Using a minimum amount of API, SARA PHARM can screen a broad and diverse parameter space in very short time. Tailored and rational experimental design and procedures yield an impressive throughput of conditions and results, all reported in a week or two.In addition to identification and production at small scale Sara Pharm can also scale…

Salt Screening Programs

SARA PHARM's salt screen program is a comprehensive search for pharmaceutically acceptable salts of ionizable drug substances using pharmaceutically acceptable counter ions (e.g acids or bases), knowledge of their physico-chemical properties, their frequency of use in drug products (e.g Orange Book), as well as their processability.

The need to use a salt is based on poor API drug substance properties such as lack of crystallinity, water solubility, or physical/chemical stability.SARA PHARM designs the salt screening program based on the desired enhancement of API properties, using well-defined ways to quickly identify the salts with optimum properties. With this clear purpose SARA PHARM…

Scaling-up & Pharmaceutical Assessment Programs

Following any screening programs SARA PHARM offers the possibility of scaling-up (to 30-50g) processes of the most important crystalline phases and stable ASD systems, followed by full characterization including Differential Scanning Calorimetry (DSC), TGA, XRPD and Single Crystal analysis (applicable to crystalline forms), Dynamic Vapor Sorption (DVS or GVS), thermodynamic and kinetic solubility and a range of other analytical tests (e.g pKa, logP/logD, NMR, IR, Raman) which are key items in pharmaceutical development.

Quick Contact SARA Pharm Solutions
Quick Contact SARA Pharm Solutions
Quick Contact SARA Pharm Solutions


Quick Contact SARA Pharm Solutions
Quick Contact SARA Pharm Solutions
Quick Contact SARA Pharm Solutions


Contact SARA Pharm Solutions

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