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Solid State Chemistry Educational Survey
Solid State Chemistry plays a very important role in the development of a drug. This includes polymorphs, cocrystals, salts and amorphous materials as well as the analysis of an API and a drug formulation with regard to their solid-state chemistry properties.

Please help us to gauge the industry's interest in an educational Solid State Chemistry course by participating in the survey:
Solid State Chemistry Educational Survey - 10% Discount
Please click here to fill in the questionnaire and register for your 10% discount off any Aptuit hosted short courses.
Solid State Chemistry Educational Survey - Anonymous
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Have you ever attended an SSCI short course?  
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Solid State Chemistry plays a very important role in the development of a drug. This includes polymorphs, cocrystals, salts and amorphous materials as well as the analysis of an API and a drug formulation with regard to their solid-state chemistry properties.

Please provide any specific topics you would like to see covered in a course of this nature:  
Please provide the names of any specific speakers you would like to see present at the course, e.g. leading academics, representatives from government:  
Simply check the most appropriate answer box for each question and click submit when you have finished:
Have you ever attended an SSCI short course?  
If yes, please rate your experience:
(from 1:Poor to 5:Outstanding)
If no, why not?
Would you be interested in a short course on Solid State Chemistry?  
What would be the ideal length of a course of this nature?
Would you be willing to pay for the educational course, if so up to how much?  
Would you be willing to travel to the course?
What level of knowledge should the course cover?
What do you normally look for when attending these types of events?
(check all that apply)




Solid State Chemistry plays a very important role in the development of a drug. This includes polymorphs, cocrystals, salts and amorphous materials as well as the analysis of an API and a drug formulation with regard to their solid-state chemistry properties.

Please provide any specific topics you would like to see covered in a course of this nature:  
Please provide the names of any specific speakers you would like to see present at the course, e.g. leading academics, representatives from government:  
Solid State Chemistry Educational Survey


Thank you


Your comments are appreciated. If you have registered for your 10% discount, please claim this at the time of booking your Aptuit-hosted course.
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Case Studies

Summary

A small Italian pharmaceutical company that is now part of a larger European entity sought Aptuit’s assistance in the development of a drug product treating inflammatory and auto immune diseases. Because of the low solubility of the API, the client was looking to identify a formulation with improved bioavailability. The decision to work with Aptuit was enhanced

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Summary

Aptuit has successfully completed several anti-sense oligonucleotides projects in various phases of clinical studies for three pharmaceutical companies. These projects required method development, phase appropriate validation and longterm stability studies of their drug substances and drug products, and testing of the in-process samples.

Aptuit has extensive experience in analyzing large molecules such as proteins, peptid....  Read More


Summary

Since 2008, Exelixis and Aptuit have been engaged in a long term strategic partnership that represents a new paradigm in pharmaceutical relationships. From the beginning, Aptuit has brought to the relationship a real understanding of Exelixis’ goal to redefine the way cancer drugs are discovered and developed, fundamentally changing the way cancer patients are treated.

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Summary
Aptuit's cGMP API facilities in Kansas City, Missouri and in Oxford, England are equipped to offer chemistry services that span development from mg to 100+Kg and include process research and development and low volume commercial manufacture. Because of Aptuit's scientific strength and expertise in the drug development process, a number of companies have entrusted their drug development programs to Aptuit API teams, from route selection to co....  Read More

Summary

Now part of a larger pharmaceutical entity, a European company engaged Aptuit in the development of a Phase I oncology study focused on capsule formulation of a cytostatic highly potent compound. The project was designed to improve the bioavailability of an immediate release capsule.

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Summary
A Chinese pharmaceutical company contracted Aptuit for an integrated program of radiolabeled synthesis and preclinical testing that included Absorption, Distribution, Metabolic and Excretion (ADME) animal studies, and in vivo profiling. Aptuit is one of just a few drug development companies that offer GLP and cGMP radiolabeled synthesis through its API Development & Manufacture group and ADME services through its Pharmaceutical Developme....  Read More

Summary
The Aptuit acquisition of Evotec’s Chemical Development business in 2007 proved to be the
catalyst for a collaborative relationship that now extends beyond its original scope. Today
Evotec is partnering with Aptuit across multiple business lines..  Read More

Summary
A large European pharmaceutical company contracted Aptuit to reformulate a tablet with existing dosage strengths of 25 mg and 50 mg. The client required smaller strengths of 0.1, 0.5, and 1, 1.5, 2.5, 5 and 10 mg. Using the existing Active Pharmaceutical Ingredient, Aptuit needed to develop all of the smaller strengths with a tablet core weight of 100 mg..  Read More

Summary
A small pharmaceutical company with an orphan drug in the early stages of drug
development approached Aptuit to develop drug product for Phase I clinical
trials. If successful, due to the orphan designation of the drug, it would then be
possible to fast track the compound through to Phase III. A simple dry blend in
capsule form was developed in doses of 5 mg, 20 mg and 100 mg..  Read More

Summary
A Phase I clinical manufacturing approach gaining in popularity is pure API in a capsule. This approach can be known as Powder In Capsule (PIC), or Chemical In Capsule (CIC). Reduced drug product development time is one reason why this technique is so appealing..  Read More

Summary
A small French company that has since become part of a large European pharmaceutical entity sought Aptuit’s assistance in the development of a dual antibiotic tablet..  Read More

Summary
The results of preclinical safety studies are crucial components in regulatory filing of a New Chemical Entity (NCE). A pharmaceutical company that had identified a pharmacological candidate for a significant unmet clinical need turned to an experienced team to partner with them in these development studies..  Read More

Summary
Poor bioavailability is a problem often faced in the drug development process. It is, in fact, one of the main reasons why companies work with Aptuit and SSCI Inc., its solid state chemistry company. Purdue Pharma brought a compound to SSCI that demonstrated poor water solubility and low in vivo concentrations when tested orally in dogs. In order to improve bioavailability, a more water soluble form of the active pharmaceutical ingredient (A....  Read More

Summary
When active pharmaceutical ingredients (APIs) are produced in multiple lots, it is possible for inconsistencies to develop in the quality (i.e. physical and chemical properties) of the drug substance. A major pharmaceutical company came to SSCI, A Division of Aptuit, when confronted with such a problem. The problem arose in the manufacture of the API for an antibiotic drug product that had been on the market for more than twenty years.  Read More

Summary
A small biotechnology company in the United States turned to Aptuit to support the development of their inhaled respiratory product. They had added confidence that their limited in-house capability would benefit from Aptuit’s substantial experience and capabilities in respiratory science projects, fulfilling their need for first-in-class capabilities in manufacturing, clinical packaging and logistics, bio-analytics and respiratory analytics.  Read More

Summary

As a drug product enters into the later clinical phases, there is a requirement to support large registration stability studies. A large European client sought Aptuit’s substantial resources to conduct large scale stability testing. Although there are a few other service providers with the capabilities to support large pharmaceutical organizations in these studies, Aptuit offers an added competency because of its large team of dedicat....  Read More

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