Objective: This work aimed to explore the possibility of using Fourier-transform infrared (FTIR) spectroscopy and chemometrics to develop multivariate models to authenticate the "halal-ity" of pharmaceutical excipients with controversial halal status (e.g., magnesium stearate).
Materials and Methods: The FTIR spectral fingerprints of the substance were used to build principal component analysis (PCA) models. The effects of different spectral pretreatment processes such as auto-scaling, baseline correction, standard normal variate (SNV), first, and second derivatives were evaluated. The optimization of the model performance was established to ensure the sensitivity, specificity, and accuracy of the predicted models.
Results: Significant peaks corresponding to the properties of the compound were identified. For both bovine and plant-derived magnesium stearate, the peaks associated can be seen within the regions 2900cm-1 (C-H), 2800cm-1 (CH3), 1700cm-1 (C=O), and 1000-1300cm-1 (C-O). There was not much difference observed in the FTIR raw spectra of the samples from both sources. The quality and accuracy of the classification models by PCA and soft independent modeling classification analogy (SIMCA) have shown to improve using spectra optimized by first derivative followed by SNV smoothing.
Conclusion: This rapid and cost-effective technique has the potential to be expanded as an authentication strategy for halal pharmaceuticals.
METHODS: As an exploratory study, its approach is to investigate at an in-depth level of understanding of safe use elements from the involved stakeholders: consumers and practitioners. We had a total of 4 focus group discussion sessions (1 FGD session with consumer and 3 FGD sessions with practitioners) as a method of collecting data from the participants. The FGDs were conducted in local native Malaysian and then being translated by researchers without changing their meanings. Thematic analysis was done which involves methodically reading through the verbatim transcripts and consequently segmenting and coding the text into categories that highlight what the participants have discussed.
RESULTS: From the result, we found that both practitioners and consumers agreed a safe FHP must be in compliance with the guidelines from the Ministry of Health Malaysia (MOH). There are other safe use elements highlighted including halal certification, trusted over-the-counter outlets, and published reports on the safety, efficacy, and quality.
CONCLUSIONS: In conclusion, both practitioners and consumers agreed that the most important safe-use element is compliance with MOH guidelines, but the depth of discussion regarding the safety elements among these stakeholders holds a very huge gap. Thus, initiatives must be planned to increase the knowledge and understanding about the MOH guidelines towards achieving a sustainable ecosystem in the safe use of FHPs.