How you explain Colorcons productmanager Daniel To positively previewing his presentation at AAPS PharmSci 360 2019 3 weeks ago....shared at LinkedIn in a video?
See below (or through this link (and search for Daniel To) the recap of his presentation:
Category: Formulation and Quality
M1230-07-44 - Novel Authentication Technology Using Molecular Tags as a PCID in Solid Oral Dosage Forms Mon, Nov 4 12:30 PM – 1:30 PM
Purpose: The World Health Organization (WHO) performed a review of papers published between 2007-2016 and estimated that 10.5% of medicines are substandard or falsified and could account for $30.5 billion of pharmaceutical sales in low- and middle-income countries.1 These medicines cover a wide range of treatment categories including cancer medicines, contraceptives, antibiotics, vaccines and other life-saving medicines.2 The FDA has issued a new guidance to address this issue by incorporating physical or chemical identifiers (PCID) into solid dosage forms.3 Positive detection of the PCID would help prevent counterfeiting by providing authentication and traceability to individual dosage forms. In this study, an Opadry® complete film coating was incorporated with the SigNature® molecular tag (Applied DNA Sciences, Inc.), a DNA based PCID, to form a fully formulated film coating system that is also a covert authentication platform. This DNA tag functions as a “molecular bar code”, enabling identification to a source, as a product type, or other meaningful attribute.
Methods: SigNature molecular tag was incorporated into blue, gray and white Opadry film coating samples and compared against untagged samples (Colorcon, Inc.). Powder samples were tested for the presence of the tag using SigNify® Reagent Mix using a SigNify® IF portable reader (Applied DNA Sciences, Inc.) based on real-time polymerase chain reaction (rt-PCR).
Tagged and untagged Opadry samples were coated onto placebo tablets (10mm, bi-convex round) to a 3% weight gain using a Labcoat I (O’Hara Technologies, Inc.). Samples of the film from the coated tablets were prepared and tested for the presence of the DNA tag as described above. Tablet appearance was compared analytically by measuring color difference using a DataColor600 (DataColor, Inc.), surface gloss using a Model 803A Surface Analysis System (TRICOR Systems, Inc.) and surface roughness using a PS50 Optical Profilometer (Nanovea, Inc.). Limit of CIELAB total color difference (DE) were defined as 2.5, 2.0 and 1.5 for blue, gray and white samples, respectively.
Both tagged Opadry dry powder and film coated tablets were placed on stability.
Results: Opadry samples were analyzed by rt-PCR and the resulting cycle threshold (Cq) was compared against negative and positive controls, as shown in Figure 1a. A higher Cq value indicates more cycle time to amplify DNA tag to threshold and therefore lower quantity of DNA. Any Cq value greater than 25 is considered non-detectable. The negative control and untagged Opadry provided a Cq >30 indicating no detection of the tag. In comparison, the tagged Opadry samples and positive control had Cq values of 10-25 confirming the presence of the tag.
Tablets coated with tagged and untagged Opadry were also tested by rt-PCR and indicated a similar trend. Untagged tablets and negative control provided no detection while tagged tablets and positive controls provided robust detection, as shown in Figure 1b. Appearance based differentiation techniques such as color difference, gloss and surface roughness could not identify significant differences between tagged and untagged tablets, as shown in Table 1.
The SigNature molecular tag in tagged Opadry powder and coated tablets were successfully detected after 3 months storage at 40°C/75%RH, indicating excellent stability.
Conclusion: SigNature molecular tag was incorporated into an Opadry film coating as a covert PCID. This is an approach to uniquely identify tablets and capsules and protect against substandard and falsified medicines. The tag could not be detected by appearance or common analytical methods; however, it could be detected by rt-PCR when used in conjunction with the matching SigNify Reagent Mix. Tagged samples of Opadry powder and coated tablets were differentiated from the untagged versions, which indicates an excellent option for an on-tablet authentication technology platform.
Presenting Author(s) DT Daniel To – Manager - Product Development, Colorcon, Inc., Harleysville, Pennsylvania Main Author(s) BP Brad Prusak – , Harleysville, Pennsylvania Co-Author(s) LJ Lawrence Jung – , Stony Brook, New York MH Mike Hogan – , Stony Brook, New York AR Ali Rajabi-Siahboomi – Vice President and Chief Scientific Officer, Colorcon, Inc., Harleysville, Pennsylvania Submitter(s) DT Daniel To – Manager - Product Development, Colorcon, Inc., Harleysville, Pennsylvania 31 Views
