Pharmaceutical dosage forms fabricated with nanomaterials for quality monitoring

Abstract

Nanomaterials fabricated to pharmaceutical dosage forms used to monitor quality of the drug product enclosed therein are disclosed. The nanomaterials are useful to provide a plurality of quality analysis to the dosage form. Consequently, the nanomaterials provide a means to perform quality testing on a continuous basis throughout the supply chain, including the cold chain whereby manufacturers and distributors can achieve greater product integrity and longer shelf life and ultimately minimize cost. The end user benefits in obtaining the highest quality drugs at the time of need.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Patent Application No. 60 / 937,924 filed 30 Jun. 2007, the contents of which are fully incorporated by reference herein.STATEMENT OF RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH[0002]Not applicable.FIELD OF THE INVENTION[0003]The invention described herein relates to the field of pharmaceutical dosage forms and nanotechnologies. Specifically, nanomaterials used for the monitoring of quality in pharmaceutical dosage form technologies. The invention further relates to the enhancement of nanotechnologies to produce higher quality more efficient drug storage forms whereby the shelf life of high quality drugs will increase.BACKGROUND OF THE INVENTION[0004]We endeavor to further the state of the art using nanomaterials in the field of pharmaceutical dosage forms and formulation technology.[0005]Nanotechnology is a field of applied science and technology covering a broad range o...

AI Technical Summary

Benefits of technology

[0030]In a further embodiment, the invention provides for a method of monitoring quality of a drug product whereby the dosage form comprises a nanomaterial fabricated into the dosage form and whereby the monitoring occurs from packaging to distribution.

[0031]In a further embodiment, the invention provides for a method of monitoring quality of a drug product whereby the dosage form comprises a nanomaterial fabricated into the dosage form and whereby the monitoring occurs from distribution to wholesale.

[0032]In a further embodiment, the invention provides for a method of monitoring quality of a drug product whereby the dosage form comprises a nanomaterial fabricated into the dosage form and whereby the monitoring occurs from wholesale to retai

Problems solved by technology

This catalytic activity also opens potential risks in their interaction with biomaterials.

However, the tendency of small particles to form clumps (“agglomerates”) is a serious technological problem that impedes such applications.

Another deficiency is that the volume of an object decreases as the third power of its linear dimensions, but the surface area only decreases as its second power.

This somewhat subtle and unavoidable principle has huge ramifications.

The drill is useless.

This is why, while super-miniature electronic integrated circuits can be made to function, the same technology cannot be used to make functional mechanical devices in miniature.

However, the ability of this to extend into supramolecular assemblies consisting of many molecules arranged in a well defined manner is problematic.

However, most useful structures require complex and thermodynamically unlikely arrangements of atoms.

Given the deficiencies associated with “top-down” and “bottom-up” nanomaterials, it becomes clear that providing a functional approach to nanotechnology (i.e. the development of nanomaterials of a desired functionality) can be problematic.

Finally, implementing nanotechnologies in highly-regulated bulk packaging applications, such as pharmaceutical formulation and dosage forms, only compounds problems.

In some equipment, this has the disadvantage of requiring the use of an additional machine that will align the softgels and hold them in a desired oriented position for the application of the dye or ink.

The use of additional equipment and procedural steps adds to the overall cost of manufacture of the softgels and, therefore, this system is considered disadvantageous.

Also, the printing of each softgel can be done over only a limited portion of the exterior surface of the softgel and may not be readily read or even seen by the consumer.

However, switching to a prefilled syringe presents its own set of challenges for manufacturers.

For example, lubrication is of limited importance in a stopper for a vial.

Determining how silicone will interact with a given drug's stability and aggregation is a problem for both formulators and fillers.

However, many variables affect these properties, such as facility temperature deviation, airflow, air quality, duration of storage, container integrity, and seasonal considerations.

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