Identifying the source of gelatin is of importance due both to concerns regarding possible disease transmission to humans, as well as religious concerns in Muslim countries (which strictly forbid porcine products). Most (90%) gelatin capsules are derived from porcine tissues due to greater strength, resistance to stress, ability to hold water, higher melting point, shorter production time (30 days versus 60–80 days for bovine gelatin), and low cost. Gelatin is produced from partial denaturation of collagen extracted from the skin, bone, and connective tissue of animals (i.e., cattle and pigs). Soft capsules are mainly filled with liquids, while hard capsules are filled with powder, and vary both in composition and production processes. Gelatin is a high molecular weight protein that is widely used as a viscous agent in hard and soft capsules. While food products are strictly monitored during halal certification, there are no such requirements for non-food products (i.e., pharmaceuticals). Halal foods (in Islam), pertains to the lawful (or blessed) food or non-food products including pharmaceuticals. Simultaneous detection of porcine and bovine DNA in gelatin capsules by duplex PCR Conclusionsĭuplex PCR presents an easy-to-follow, quick, low-cost and reliable method to simultaneously detect porcine and bovine DNAs (>100 bp) in minute amounts in highly processed gelatin-containing pharmaceutical products (with a 0.1% sensitivity for porcine DNA) which may be used for halal authentication. Of all gelatin capsules tested ( n = 24), 50% contained porcine DNA (pure porcine gelatin alone or in combination with bovine gelatin). Resultsĭuplex PCR detected the presence of as little as 0.1% porcine DNA, which was more accurate than the commercially available kit. After optimization of DNA extraction and PCR methods, hard/soft pharmaceutical gelatin capsules (containing drug) were tested for the presence of porcine and/or bovine DNA. Some additional simplex PCR tests (targeting 126 bp bovine and 212 bp porcine mtDNA) and real-time PCR using a commercially available kit (for identification of porcine DNA) were used to verify the selectivity and sensitivity of our duplex PCR. We developed a species-specific duplex polymerase chain reaction (PCR) assay targeting 149 bp porcine and 271 bp bovine mitochondrial DNA (mtDNA) to simultaneously detect both porcine and bovine DNA (in one reaction at the same time) in gelatin. To ensure that pharmaceutical products comply with halal regulations in Muslim countries (no porcine products allowed), development of a valid, reliable, quick, and most importantly, cost-effective tests are of utmost importance. In the pharmaceutical industry, hard- and soft-shelled capsules are typically made from gelatin, commonly derived from bovine and porcine sources.
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