Contract Research

As part of its technical support to researchers working with Trappsol®, CTD, Inc. provides fee-for-service solubility, stability, and complexation studies.

A. SOLUBILITY TESTING
A number of standard protocols are described. CTD, Inc. can determine the best cyclodextrin to be used with your compound in terms of cost and/or product enhancement.

CTD offers technical and consulting services regarding cyclodextrin applications ranging from feasibility studies to complete product development programs. Both standard and customized services are available. Confidentiality agreements are welcomed and encouraged.

Research and consulting services are available on an hourly or project basis. Since successful complexation cannot be assured and CTD routinely looks at several Cyclodextrin candidates, a minimum charge of $1500.00 should be anticipated for laboratory work. A firm quotation of time required and cost will be provided before any charges are billed.

Type of study	Typical time for completion (1)	Cost by Type of Assay (2)
		UV	HPLC
Maximum Solubility	4 Weeks	$2,000.00	$4,000.00
Phase Solubility (3-5 points)	6 Weeks	$6,000.00	$9,000.00
pH effects (3-5 points) at one concentration	6 Weeks	$6,000.00	$9,000.00
Temperature effects (6-8 points) at one concentration	6 Weeks	$6,000.00	$9,000.00
All studies listed above	12 Weeks	$18,000.00	$25,000.00

1.	Specific completion times will be quoted at initiation of the study. CTD reserves the right to notify the customer of necessary time extensions.
2.	Prices assume customer provides assay protocol. If assay is not available, CTD will provide a separate estimate of cost.

B. STABILITY TESTING
CTD offers stability tests on complexes of compounds with Trappsol-Cyclodextrin's and/or solutions of the compound and Trappsol-Cyclodextrin's. Because stability studies may have many variables, the time required for completion and cost will be quoted based on specific requests. CTD can provide advice and recommend the stability testing protocol that will most efficiently achieve the stated goal. Variables that may be considered are pH, heat, light, oxidation, and humidity.

To be provided by the client:

Material

2 - 5 gram of active compound per study

Information (if available):

UV spectrum
Chromatographic assay
Refractive index data
Known hazards
Fluorescent spectrum
Redox data
Stability in aqueous systems
Special handling requirements

What client receives:

Brief written report and graph of results
Unused active compound
Concentrated solution of Trappsol/compound with concentration noted
Freeze dried complex with compound content and incorporation rate noted

Condition of Study

CTD, Inc. will combine its knowledge of Trappsol products with information from the client on his compound to complete the study to the best of its ability and report the results to the client. No assurances of favorable results are implied or given by the agreement to undertake a study. CTD cannot be responsible for results due to a compound's lack of aqueous stability, inadequate response to detection methods (e.g. UV, fluorescence) or other limiting factors not known when the study was initiated.