Glatt Air Techniques, Inc.
Glatt Air Techniques, Inc.
Headquarters
Ramsey, New Jersey
Location(s)
Ramsey, New Jersey
Years in Drug Formulation
20 Years
Spokesperson
Gary Selander
| Areas of research | |||||||
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Small Molecule |
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Biological |
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Other | ||
| Drug Formulation Services Offered | ||||
| • | Analytical method development | • | Bioavailability enhancement | |
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Compatibility studies of active ingredients |
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Dosage form selection | |
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Excipient compatibility |
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Formulation optimization | |
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Formulation stress testing |
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in silico studies | |
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Manufacture of clinical supplies |
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Novel delivery system | |
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Packaging compatibility assessment |
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Particle size reduction | |
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Preclinical studies |
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Solubilizing water-insoluble drugs | |
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Stability studies |
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Taste masking/flavorings | |
| Other Services Offered | ||||
| Disease Research | Target Identification | |||
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Lead Identification |
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Early Safety Tests | |
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Lead Optimization |
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Pre-clinical Studies | |
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IND Submission |
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Clinical Trials | |
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NDA Submission |
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Post-marketing Studies | |
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ANDA Submission |
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| Types of Drugs | |||||||
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Generics |
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Prescription |
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OTC | ||
| Dosage Forms | ||||
| • | Capsules | Implantable | ||
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Inhalation |
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Injectible | |
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Oral |
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Parenteral | |
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Peptide and Protein |
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Tablets | |
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Topical |
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Company’s role in drug discovery and developmnet
Glatt Air Techniques is dedicated to the development of solid, oral dosage forms from pre-formulation studies through commercial scale, GMP production. Our efforts are supported by a modern facility equipped to produce feasibility batches as small as 500 grams and scale up, potentially, to commercial batches of 2 metric tons.
Company’s experience and expertise in drug formulation
Glatt Air Techniques has extensive experience in the development and production of the “hard to craft”, modified release dosage form. We are particularly adept at pellet development through drug layering processes in Wurster inserts, as well direct spheronization through our proprietary CPS process. We are also offering an excellent ODT technology platform. We welcome opportunities that challenge us.
Relationship with pharma companies
With Glatt Air Techniques, Inc., drug formulation and contract manufacturing opportunities may take the form of a business partnership or may operate as a more conventional, fee for service agreement. We feel that offering our services on a flexible basis allows us appeal to a wider client base.
Factors critical for drug formulation
For the generic product, nothing will trump speed, a great biostudy match and economy of production. For the new drug, a thorough comprehension of the basics is essential, i.e., solubility profiling, BCS class, morphology / polymorphism studies, potential for ionization, site of absorption, excipient compatibility study, etc.. Here, the homework is what leads to success.
Business/regulatory trends impacting drug formulation
We see a clear trend towards the development of multiple API dosage forms, an increasing emphasis on fewer dosage forms to be taken over time, and a frequent need to control the morphology of the dosage form during the production process. These issues,and the frequent desire to legally circumvent dosage form patents, are driving the need for formulation and production innovation. Additionally, we see the demand for ODT formulations as an area of considerable opportunity.
The continuing globalization of the industry is driving the demand for development and production compliance with multiple agencies at once.
Filed Under: Drug Discovery
