WHAT IS INFORMex?
INFORMex is the most essential module of . It is a comprehensive, versatile and interactive component that allows the formulations scientists to enter/import or display the test results of analytical, preformulation and/or formulation studies performed on the pharmaceutical materials (including excipients, active substances, intermediate and final formulations) as well as other relevant information, such as material safety data sheets, suppliers, supplier provided technical information, and literature data, etc.
On the basis of the extensive experience that our scientific team have in the area of solid dosage forms, INFORMex module has been designed to include a number of commonly used tests, including (but not limited to): Bulk, tapped and true densities; surface area; moisture content; angle of repose and gravimetric flow; particle size; analysis; Carr's index profile; Hausner ratio profile, compaction properties; SEMs; DSC profiles, and formulation properties (such as drug release profiles, as well as tablet friability, disintegration, breaking force profiles). Other relevant information includes (but not limited to): MSDS; list of suppliers; supplier profiles; global availability of the materials, and SOPs of the tests.
INFORMex module can be further customized to suit the needs of any individual company by adding new tests for any dosage form.
MAIN (Customizable) FEATURES/COMPONENTS OF INFORMex:Applicable Areas:
process developmentDosage Forms:
solids (tablets, capsules, granulations
solutions and suspensions
Data Entry for Materials:
Material Data entry is divided into sub groups (types and number of which can be determined during the customization phase of the INFORMex module (See below - Development Stages).
The current templates include data entry for materials (Excipients, APIs, Intermediate products and final products).
Data Entry for Test Results:
INFORMex allows the user to enter/display for a number of test results for each pharmaceutical powder/product: These tests includes (but not limited to):
bulk, tapped and true densities,
angle of repose and gravimetric flow,
mean particle size,
particle size distribution,
DSC profiles, and
formulation properties (such as drug release profiles, as well as tablet friability, disintegration, breaking force profiles)
In addition to the default system tests, the software allows the user to add user definable tests from a number of templates.
Data entry for test results is also divided into sub groups. Some tests are better suited for manual entry while others can be imported from files such as txt, csv, xls, etc. and the analyzed data are displayed in seconds in tabular or graphical forms.
Also, some test results can be grouped (as an option). For example, the user can enter the bulk, tapped, absolute, envelope density readings either individually or as a group under the name of, say, called Density Properties. Similarly, flow properties can be entered individually or as a group under the name of, say, Flow Properties. In all cases, the number and the type of tests and how to group them are determined during the customization stage.
Please note that regardless of the type of the entry (manual or not), the statistical information is automatically calculated.
Data Entry for Process Conditions:
If the client wishes to store certain processing information, the software can be fully customized in a way that the user can easily enter (or import) data for processing conditions and each entry can be integrated to the search engine, as well.
Display of the Test Results:
Once the test results are recorded (using manual entry or data importing feature), then the user has numerous standard and/or customized option for data analysis.
For example, the user can create a analysis profile by selecting the materials (any combination of the excipients, API’s, intermediates, or products) and the tests of his/her interest.
In fact, each user can prepare as many analysis profiles as they wish. Once such a profile is created, then the comparison of the results for all of the selected tests and materials will be just a click away. For example, the user can easily view the full preformulation profile for:
a single entry (excipient,, active, intermediate or product), or
batch history, supplier to supplier variation, grade to grade variation for a given material, or
comparison of different materials (excipients, actives, intermediate, or final product formulations).
The user can access to the program as trainee, expert or administrator. The number of levels and privilege of each level is customized.
The administrator(s) can set up the privileges of each user as well as the defaults of all user-defined features of the software.
The user can enter a number of desired properties and then search for material(s)/formulations with these properties. The user can also be able to view excipients by filtering according to the functionality (active, binder, lubricant etc), availability (N. America, Europe, Japan etc), and pharmacopeia requirements (USP-NF, Ph. Eur., JP etc). Similarly, the search engine can be utilized for process conditions, as well. These features of the program can be as much extensive as needed to meet the client’s needs.
The client provides PTI Inc. with a list of tests (and specifications) and appropriate number of examples for each test.
PTI customizes INFORMex according to the test specifications provided by the client.
The client tests the software for final approval
A training session is held upon the approval of the software.
Hardware/ Operating System:
INFORMex can reside either in a single notebook/netbook (provided by PTI, Inc) or in a server (although a server. The number of users would depend on the extend of the license agreement. The information generated by the users is stored either in the computer or an external drive, depending on the preference of the client. Both the laptop and the external drive are provided by PTI, Inc.
Access Levels and Security:
The application is protected by a “soft-lock” system that prevents unauthorized use or duplication of the program. INFORMex is accessed by using a password and its each customized version may contain additional copy‑protection features to control the unauthorized distribution and/or the use of the program.
Target User Capability:
The typical user of INFORMex must have a working knowledge of Windows XP/Vista and be able to select items from menus and dialog boxes presented on the screen.
Upon delivery of the final version INFORMex, a complete set of operating instructions for its use is provided to the client.
Each customized version of INFORMex is usually developed within 12 to 24 weeks, provided the client will provide any required information in a timely manner.
PTI will provide free service for a period of three months after the delivery of the unit to trouble shoot any software related problems encountered during this period. The warranty for the hardware is one year.
All of the copy and other applicable rights of this program, including the software technique to be used to develop the program, and the rights to change the name of the software are owned by PTI, Inc,
Leasing i.e., yearly licensing
Purchasing, i.e., permanent licensing
Leasing with an option to purchase
Depending on the leasing option selected, a yearly, free or fee based renewable maintenance service is provided to trouble shoot any problems encountered after the expiration of warranty. The yearly maintenance service includes trouble shooting both software and hardware related problems.