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Animal Products in Pharmaceuticals

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Animal product additives in pharmaceuticals play a role as both active and inactive ingredients. Animal products in pharmaceuticals are inactive ingredients when used as binders, carriers, stabilizers, fillers, and colorants.[1] Biologics and some vitamins are use cases for animal products as active ingredients in pharmaceuticals.

The religious, cultural, and ethical concerns of patients are increasing in importance as the use of animal products in pharmaceuticals, particularly the use of biologics, rise.[2]

Inactive Ingredients[edit]

Gelatin[edit]

One of the most common animal products in medicine is Gelatin.[1] Gelatin is derived from animal skin, bone, and tissue most often from pigs or beef.[3] There is no practical way of determining if the gelatin used in pharmaceuticals is derived from beef or pork. It is used primarily for gel capsules and as stabilizers for vaccines.[4] A non-animal derived alternative to gelatin is Pectin as a gelling agent or Cellulose for creating vegetable capsules.[5]

Stearic Acid[edit]

Cattle are the source of gelatin, stearic acid, and tallow used in pharmaceuticals.

Another common animal-derived additive is Stearic acid. Stearic acid can be derived from vegetables or animals such as cows, sheep, dogs, or cats.[4] There is no practical method for determining the source of stearic acid in pharmaceuticals. Stearic acid is far more abundant in animal rather than vegetable sources. Lard and tallow, for example, contain up to 30% stearic acid.[6]

Sodium Tallowate[edit]

Sodium tallowate is a common soap ingredient derived from tallow—the fat of animals such as cattle and sheep.[7] Soaps which include the use of sodium tallowate include Dove, Dial, and Ivory. A popular alternative to this ingredient is sodium palmate, which is derived from palm oil.[8]

Vaccines[edit]

According to the American Food and Drug Administration "Cow components are often used simply because cows are very large animals, commonly used for food, and thus much material is available." Although cows are most commonly used, animal products in vaccines can be from a variety of animals. Within the vaccine, the inactive components from animal sources can include amino acids, glycerol, detergents, gelatin, enzymes and blood.[9]

Biologics[edit]

Xenotransplantation is the transplantation of non-human animal tissues, cells, and organs into a human recipient.[10] According to the Food and Drug Administration, xenotransplantation presents public health risks, including transmitting viruses, bacteria, or other organisms to humans that may not be pathogenic or detectable in the source animal.[11]

Vitamins[edit]

Vitamin D2 is most often sourced from plants, while vitamin D3 is most often sourced from sheep's wool.[12]

References[edit]

  1. 1.0 1.1 "Is Your Medicine Vegan? Probably Not". NPR.org. Retrieved 2020-03-04.
  2. Roy, Avik. "Biologic Medicines: The Biggest Driver Of Rising Drug Prices". Forbes. Retrieved 2020-03-04.
  3. "Gelatin | animal protein". Encyclopedia Britannica. Retrieved 2020-03-04.
  4. 4.0 4.1 "Medicines/Pharmaceuticals of Animal Origin" (PDF). Queensland Health. January 4, 2019. Retrieved March 9, 2020. Unknown parameter |url-status= ignored (help)
  5. Prakash, Ajay; Soni, Hariom; Mishra, Abhishek; Sarma, Phulen (2017). "Are your capsules vegetarian or nonvegetarian: An ethical and scientific justification". Indian Journal of Pharmacology. 49 (5): 401–404. doi:10.4103/ijp.IJP_409_17 (inactive 2020-04-25). ISSN 0253-7613. PMC 5830853. PMID 29515283.
  6. "Stearic acid | chemical compound". Encyclopedia Britannica. Retrieved 2020-03-09.
  7. "Tallow | biochemistry". Encyclopedia Britannica. Retrieved 2020-03-29.
  8. "About Sodium Palmate - Tom's of Maine". www.tomsofmaine.com. Retrieved 2020-03-27.
  9. Research, Center for Biologics Evaluation and (2019-03-20). "Bovine Derived Materials Used in Vaccine Manufacturing Questions and Answers". FDA.
  10. "U.S. Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation". Morbidity and Mortality Weekly Report: Recommendations and Reports. 50 (RR-15): i–46. 2001. ISSN 1057-5987. JSTOR 42000864.
  11. "Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans: Guidance for Industry". fda.gov. US Food and Drug Administration. December 2016. p. 2. Retrieved 11 April 2020. This article incorporates text from this source, which is in the public domain.
  12. "FAQs About Vitamin D | Vegetarian Journal | Vegetarian Resource Group". www.vrg.org. Retrieved 2020-04-10.


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