Course:SPPH381B/TermProject/Tylenol -Alex Kitt

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Introduction

Tylenol [1]

Extra Strength Tylenol® is a drug produced by McNeil Consumer Healthcare, a division of Johnson and Johnson Inc., and is used to treat both pain and fevers [2]. Today, Tylenol is one of the most popular choices for over-the-counter pain relievers, ranked as the 4th most popular brand in 2013 for revenues (generating over $200,000,000 USD)[3].

It’s active ingredient, acetaminophen (also called APAP or paracetamol), belongs to the non-opioid analgesic class of drugs [4] and acts on the central nervous system by inhibiting the production of prostaglandins [5] . Since the patent on Tylenol® expired, many generics containing acetaminophen have been produced, causing APAP to become one of the most popular pharmaceutical drugs in the US, with over 24.6 billion doses sold in 2008 [6] . One study even placed acetaminophen as the most commonly used drug by adults in the US [7] .

While Tylenol ® (and its generic products) is considered to be a safer pain-reliever than opioids or NSAIDs (Non-Sterile Anti-Inflammatory Drugs) such as aspirin [8] , it still poses significant threats if dose is exceeded, especially in long-term use. Of all the cases of acute liver failure in the US annually, acetaminophen use was the most common cause [9] .


Steps

The general steps for Tylenol® production (starting with acetaminophen production) are as follows:

  1. Resource Extraction: Petroleum
  2. Primary Manufacturing: Synthesis of Acetaminophen
  3. Secondary Manufacturing: Production of Completed Tylenol Pill
  4. Transportation: Road
  5. Support Infrastructure: Pharmaceutical Development

Petroleum Extraction

In the US, approximately 180,000 people are employed in the petroleum extraction industry. This industry poses significantly higher levels of risk than others, with an occupational fatality rate seven times the national average [10]. The general steps involved in extraction of petroleum are outlined below [11] :

  1. Locating Oil Deposits
  2. Drilling
  3. Extraction
    1. Primary Extraction
    2. Secondary Extraction
    3. Tertiary Extraction
  4. Pipeline transportation to Refineries

For more information on drilling see here.

Acetaminophen Synthesis

Following extraction, the crude oil needs to be distilled and processed as follows:

  1. Distillation of Crude Oil to Produce Naphtha [12]
  2. Catalytic Reforming: Naphtha to Benzene [13]
  3. Benzene to Acetaminophen [14]

For more information on petroleum processing see here.

Production of Complete Tylenol Pill [15]

Once the acetaminophen and all other ingredients have been produced, they are processed into the final pill form:

  1. Weighing and Dispensing
  2. Charging and Discharging Solids and Liquids
  3. Liquid Separations
  4. Transferring Liquids
  5. Filtration
  6. Compounding
  7. Granulation
  8. Drying
  9. Milling
  10. Blending
  11. Compression
  12. Solid-Dosage Form Manufacturing: Coating
  13. Packaging

Pharmaceutical process

For more information on blending

Transportation by Road

To distribute the final Tylenol® pills to the distribution centres (or to planes, boats, etc. for intermodal transportation), driving is used:

  1. Loading of Tylenol onto vehicles
  2. Driving to destination
  3. Unloading of Tylenol at distribution site

For more information on Driving

Pharmaceutical Development [16]

The general production of pharmaceuticals from discovery to market is as follows:

  1. Discovery and Development
  2. Pre-Clinical Research
  3. Clinical Research
  4. FDA Review
  5. FDA Post-Market Safety Monitoring

More information on pharmaceutical drug development see here.

References

  1. ↑ Time Business Blog. (2012, October 15). Tylenol and the Legacy of J&J’s James Burke. Retrieved from https://timebusinessblog.files.wordpress.com/2012/10/94579879.jpg?w=480&h=320&crop=1
  2. ↑ Johnson & Johnson. (2015). TYLENOL® Extra Strength. Retrieved from https://www.tylenol.ca/products/headache-migraine/tylenol-extra-strength
  3. ↑ Statista. (n.d.). Top 10 OTC brands for pain relief by revenue in the U.S. in 2013 (in million U.S. dollars). Retrieved from https://www.statista.com/statistics/303406/leading-us-over-the-counter-brands-for-pain-relief/
  4. ↑ Twycross, R., Pace, V., Mihalyo, M., Wilcock, A. (2013). Acetaminophen (Paracetamol). Journal of Pain and Symptom Management. 46:5, 747-755.
  5. ↑ New World Encyclopedia. (2016, February 11). Acetaminophen. Retrieved from: http://www.newworldencyclopedia.org/entry/Acetaminophen
  6. ↑ U.S. Food and Drug Administration. (2009, June 29). Acetaminophen: Background and Overview. Retrieved from https://www.fda.gov/downloads/Advisor.../UCM175767.pdf
  7. ↑ Kaufman, D. Kelly, J., Rosenberg, L. (2016). Recent Patterns of Medication Use in the Ambulatory Adult Population of the United States. JAMA. 287(3):337-344. doi:10.1001/jama.287.3.337
  8. ↑ Roberts E, Delgado Nunes V, Buckner S, et al. (2016) Paracetamol: not as safe as we thought? A systematic literature review of observational studies. Annals of the Rheumatic Diseases. 75:3,552-559.
  9. ↑ Bower, WA., Johns, M., Margolis, HS, Williams, IT., Bell, BP. (2007). Population-based surveillance for acute liver failure. The American Journal of Gastroenterology.102:11, 2459-2463.
  10. ↑ Centre for Disease Control and Prevention.(2015). Occupational Fatalities During the Oil and Gas Boom — United States, 2003–2013. Retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6420a4.htm
  11. ↑ Petroleum.co.uk. (2015). Location and Extraction. Retrieved from http://www.petroleum.co.uk/location-and-extraction
  12. ↑ The Essential Chemistry Industry. (2014, September 7). Cracking and related refinery processes. Retrieved from http://www.essentialchemicalindustry.org/processes/cracking-isomerisation-and-reforming.html
  13. ↑ ICIS. (2007, November 1). Benzene Production and Manufacturing Process. Retrieved from https://www.icis.com/resources/news/2007/11/01/9075160/benzene-production-and-manufacturing-process/
  14. ↑ IHS Markit (2002, December). Acetaminophen. Retrieved from https://www.ihs.com/products/chemical-technology-pep-reviews-acetaminophen-2002.html
  15. ↑ International Labor Organization. (2011, October 27). Pharmaceutical Industry. Retrieved from http://www.iloencyclopaedia.org/part-xii-57503/pharmaceutical-industry
  16. ↑ US Food and Drug Administration. (2015). The Drug Development Process. Retrieved from https://www.fda.gov/forpatients/approvals/drugs/
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