SCBEjr01The Life Cycle Assessment of Maize

Starch, Colloidal Silicon Dioxide and Croscarmellose Sodium as

Disintegrants By Kim Minseo and Serene Koh (Methodist Girls School)

Purpose of Investigation

￮ To determine the most sustainable disintegrant based on mass efficiency, environmental sustainability and medical side effects

￮ To conduct cradle-to-gate life-cycle-analyses (LCAs) on disintegrants found in painkillers

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Specific Definitions￮

￮ Yield → the amount of final product obtained through the reacting of raw materials/substrates

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Process of Investigation

Assumptions MadeMethodology

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Assumptions Made￮ Information on excipients is applicable

to our research question￮ Data collected from the scholarly

articles are still relevant to our research, even though production methods may have changed

￮ Excipients may be produced through different methods

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Methodology￮ An intensive study of academic and

credible literature on three selected disintegrants

￮ Topics covered:￮ Mass sustainability￮ Environmental sustainability￮ Health effects

￮ Results were compared with one another, and the superior excipient was chosen from the three that had been evaluated

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Results and

DiscussionMass Comparison

Pregelatinised Maize Starch Colloidal Silicon DioxideCroscarmellose Sodium

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Mass Comparison

Optimum %Mass needed

per kg of tablet/g

% yield from raw material

Mass of excipient

needed per kg of

tablets/g

Maize Starch 5 50 66.7 75.0

Colloidal Silicon Dioxide 5 50 28.8 174

Croscarmellose Sodium 2 20 90.0 22.2

Table 1:Comparison of mass sustainability of disintegrants

Pregelatinised Maize Starch - Environment

￮ Steeped in 0.1 - 0.2% sulfur dioxide for 20 hours at 48-52˚C to soften kernels for separation

￮ Untreated steepwater is often disposed of in rivers￮ Can pollute and disrupt river

ecosystems if left untreated before disposal

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Pregelatinised Maize Starch - Environment

￮ Due to the high concentration of soluble solids in the steepwater, there is a high chemical oxygen demand

￮ As the solids in steepwater decompose, large quantities of oxygen are used, disrupting the existing ecosystem by depleting the oxygen supply in the water

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Pregelatinised Maize Starch - Health

￮ Maize starch is safe to use as a disintegrant

￮ Anyone who can consume maize is able to ingest this disintegrant

￮ Allergic reactions to maize are rare, numbering < 1%

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Colloidal Silicon Dioxide - Environment

￮ Copious amounts of raw materials are required for the flame hydrolysis process for synthesis of CSD￮ Raw materials are purely

inorganic and of an extremely pure nature

￮ Colloidal silicon dioxide formed takes the form of a pure amorphous powder

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Colloidal Silicon Dioxide - Health

￮ Possibly carcinogenic in nature￮ Relationship between an increased risk

of pulmonary diseases and the inhalation of colloidal silicon dioxide has been observed

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Croscarmellose Sodium - Environment

Cotton Floc￮ Difficult to cultivate

efficiently due to the manufacturer having to balance yield potential of cotton and the growth of the plant

￮ Take around 5 months to be harvested

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Wood Pulp￮ Can be found as

waste from when trees are used to produce starch, e.g sago palms

￮ A readily available resource

Croscarmellose Sodium - Health

￮ Ingestion may be linked to increased risk of cardiovascular diseases

￮ Patients that ingested medical formulations containing sodium compounds were more likely to have hypertension in the ratio 7:18 (George, J., Majeed, W., Mackenzie, I. S., Macdonald, T. M., & Wei, L., 2013)

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ConclusionConclusion

AcknowledgementsBibliography

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Conclusion

Maize Starch Colloidal Silicon Dioxide

Croscarmellose Sodium

Mass Efficiency 2 3 1

Environmental Sustainability 2 3 1

Health Effects 1 3 2

Overall Ranking 2 3 1

Table 2:Comparison of disintegrants

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Acknowledgements￮ The authors wish to thank Associate Professor Kunn

Hadinoto Ong for guiding them through the process of this study.

￮ This study was done under the Nanyang Research Program (NRPjr).

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An, V., & Katrien, B. (2015). Life Cycle Assessment study of starch products for the European starch industry association (Starch Europe): sector study.Cox, S. (2008). Pharmaceutical Manufacturing Handbook. doi:10.1002/9780470259818Diaz, R., & Rosenberg, R. (2008). Spreading Dead Zones and Consequences for Marine Ecosystems. Science, 321(5891), 926-929. doi: 10.1126/science.1156401Evonik. AEROSIL® and AEROPERL® Pharma Colloidal Silicon Dioxide Products [Ebook]. Retrieved from https://www.aerosil.com/sites/lists/RE/DocumentsSI/TI-1415-AEROSIL-and-AEROPERL-Pharma-Colloidal-Silicon-Dioxide-Products-EN.pdfEyjolfsson, R. (2015). Chapter 1 - Introduction. Design And Manufacture Of Pharmaceutical Tablets, 1-28. doi: 10.1016/B978-0-12-802182-8.00001-5Ferrari, J. V., Júnior, E. F., Ferrari, S., & Luques, A. P. (2015). Vegetative growth response of cotton plants due to growth regulator supply via seeds. Acta Scientiarum. Agronomy, 37(3), 361. doi:10.4025/actasciagron.v37i3.19664

Bibliography

20

Freeman, C., Weiner, M. L., Kotkoskie, L. A., Borzelleca, J., & Butt, M. (2003). Subchronic and Developmental Toxicity Studies in Rats with Ac-Di-Sol Croscarmellose Sodium. International Journal of Toxicology, 22(3), 149-157. doi:10.1080/10915810305108George, J., Majeed, W., Mackenzie, I. S., Macdonald, T. M., & Wei, L. (2013). Association between cardiovascular events and sodium-containing effervescent, dispersible, and soluble drugs: Nested case-control study. Bmj, 347(Nov26 3). doi:10.1136/bmj.f6954Guinée, J. B. (2010, September 2). Life Cycle Assessment: Past Present, and Future. International Symposium on Life Cycle Assessment and Construction.Hartesi, B., Sriwidodo, Abdassah, M., & Chaerunisaa, A. (2016). Starch as Pharmaceutical Excipient. International Journal Of Pharmaceutical Sciences Review And Research, 59-64.Haywood, A., Glass, B. D. (2011, August 1). Pharmaceutical excipients – where do we begin? Retrieved from https://www.nps.org.au/australian-prescriber/articles/pharmaceutical-excipients-where-do-we-begin#article-tab

Bibliography

21

How A Cotton Plant Grows. (n.d.). Retrieved from https://sanangelo.tamu.edu/extension/agronomy/agronomy-publications/how-a-cotton-plant-grows/Ji, Y., Seetharaman, K., & White, P. (2004). Optimizing a Small-Scale Corn-Starch Extraction Method for Use in the Laboratory. Cereal Chemistry Journal, 81(1), 55-58. doi: 10.1094/cchem.2004.81.1.55Lessard, L. (2015, April 16) LCI of nanomaterials production: current state and challenges. Retrieved from http://users.abo.fi/rzevenho/D6-4Annex2pres5%20Lindsay%20final%20Nanoparticle_LCI_TurkuWorkshop_2015_04_15.pdf.Merget, R., Bauer, T., Küpper, H. (2001, 29 November). Health hazards due to the inhalation of amorphous silica. Retrieved from https://doi.org/10.1007/s002040100266Paul, M., & Meyer, J. (2001). STREAMS IN THE URBAN LANDSCAPE. Annual Review Of Ecology And Systematics, 32, 333-366.

Bibliography

22

Penn State Hershey Children's Hospital. Caring for your Child's Nutrition [Ebook]. Penn State. Retrieved from https://www.pennstatehershey.org/documents/10293686/10323773/Corn+Allergy/77eedae2-30a7-4e7b-be72-4588d35a6327Pushpamalar, V., Langford, S., Ahmad, M., & Lim, Y. (2006). Optimization of reaction conditions for preparing carboxymethyl cellulose from sago waste. Carbohydrate Polymers, 64(2), 312-318. doi:10.1016/j.carbpol.2005.12.003Ramírez, E., Johnston, D., McAloon, A., & Singh, V. (2009). Enzymatic corn wet milling: engineering process and cost model. Biotechnology For Biofuels, 2(1), 2. doi: 10.1186/1754-6834-2-2Shihora, H., & Panda, S. (2011). Superdisintegrants, Utility in Dosage Forms: A Quick Review. Journal Of Pharmaceutical Science And Bioscientific Research, 1(3), 148-153.Solutions, N. Croscarmellose Sodium supplier distributor- CAS 74811-65-7. Retrieved from https://www.parchem.com/chemical-supplier-distributor/Croscarmellose-Sodium-001953.aspx

Bibliography

23

Vandecruys, R., & Jans, E. (2003). PREGELATINIZED STARCH INA CONTROLLED RELEASE FORMULATION. USA.WAN, L., & PRASAD, K. (1989). Uptake of water by excipients in tablets. International Journal Of Pharmaceutics, 50(2), 147-153. doi: 10.1016/0378-5173(89)90139-7Yasri, N., Yaghmour, A., & Gunasekaran, S. (2015). Effective removal of organics from corn wet milling steepwater effluent by electrochemical oxidation and adsorption on 3-D granulated graphite electrode. Journal Of Environmental Chemical Engineering, 3(2), 930-937. doi: 10.1016/j.jece.2015.03.019VIVASOL®. (n.d.). Retrieved from https://www.jrspharma.com/pharma_en/products-services/excipients/superdisintegrants/vivasol.php

Bibliography

Thank you!Study conducted by Kim Minseo and

Serene Koh of Methodist Girls School (MGS)

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