(T1030-07-40) Delivering Smarter Medicines with On-Dose Microtaggants and Smartphone Technology

Purpose: Drug counterfeiting and diversion is an escalating problem due to low risks and high potential rewards for criminals. The most significant impact on the continued growth of counterfeit drugs is the increased availability of fake products through e-commerce; especially illegal online channels. Medicines are often separated and repackaged from the original, making serialization and track and trace solutions no longer effective. On-dose authentication provides an additional layer of protection directly on the dosage form that can easily verified¹.  This innovative technology, where a microtaggant is added to a tablet as part of the film coating, enables patients to verify their medicine directly using a smartphone. These smart medicines can be scaled to provide real-time data collection and analysis that will improve patient engagement, reduce medication errors and identify fake or diverted medicines. The current study uses microtaggants made from silicon dioxide, a common excipient used in pharmaceutical formulations. The microtaggant is chemically inert, extremely resilient, and considered GRAS. These microtaggants are microscopic particles that are virtually invisible to the naked eye and have been engineered to reflect a unique spectral fingerprint that can be confirmed through a smartphone app. In this study, the microtaggants were added to Opadry® complete film coating systems (clear and white pigmented) and applied to placebo tablets. The tablets were then evaluated for authenticity and performance attributes investigated during storage at ambient and accelerated conditions.

Methods: Opadry samples (clear and pigmented) with and without silica-based microtaggants were coated, using a Labcoat I fitted with a 12” fully perforated coating pan (O’Hara Technologies, Inc.), onto 360 mg placebo tablets using identical coating conditions, described in Table 1. The clear coating was applied to 1% weight gain (WG) and to achieve color uniformity the pigmented coating was applied at 3% WG. Following coating, the tablets were stored in induction sealed (120 mL HDPE) bottles under 40°C/75% RH conditions for 6 months. Authentication was performed through a custom-designed smartphone app using an android mobile phone. Tablets were considered fake or non-authentic if microtaggants were not detected on either face of a selected tablet. Fifty tablets from each storage condition were tested unless specified. The smartphone app took less than 10 seconds to authenticate a tablet.

Results: The physical appearance of tagged and untagged tablets for both clear and white formulations was comparable with no visible differences (Figure 1). The smartphone confirmed 100% authentication of tablets containing microtaggants in the coating, while the standard coated tablets showed no microtaggants present (Figure 1). Both clear and pigmented tablets, with microtaggants, showed 100% authentication during the accelerated stability studies (Figure 2).

Conclusion: Tablets coated with an Opadry film coating containing microtaggants were authenticated and differentiated from coated tablets without the microtaggant using the proprietary smartphone app. The presence of the taggants could not be visually detected. Tablets showed excellent stability at accelerated conditions over 6 months. The study demonstrated the use of the application of silica-based microtaggants for on-dose authentication using smartphone verification. These smart medicines can authenticate and provide real-time data collection that will improve patient engagement, reduce medication errors and identify fake or diverted medicines.

References: 1. Kon SB, Mikov M. Counterfeit drugs as a global threat to health. Med Pregl. 2011;64(5-6):285-90.
2. “Trade in counterfeit pharmaceutical products”. PDF, Illicit Trade, OECD and the European Union Intellectual Property Office, 2020. https://www.oecd.org/gov/trade-in-counterfeit-pharmaceutical-products-a7c7e054-en.htm
3. Prusak B, To D, Performance and stability of an on-dosage authentication technology using molecular tags on the coated a model active. AAPS 360 (2021)

Table 1: Opadry Coating Process Parameters



Figure 1: Opadry Coated Tablets, With and Without Silica-Based Microtaggants.



Figure 2: Authentication for Microtagged Placebo Tablets Stored for 6 Months 40°C/75% RH