Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) Roles in the Pilot Scale up Process and Stability of a Cosmetic Cream

Authors

  • Sharifah Shakirah Syed Omar Department of Pharmaceutical Technology, Faculty of Pharmacy, International Islamic University Malaysia (IIUM), Pahang, Malaysia
  • Hazrina Ab Hadi Department of Pharmaceutical Technology, Faculty of Pharmacy, International Islamic University Malaysia (IIUM), Pahang, Malaysia
  • Abd Almonem Doolaanea Department of Pharmaceutical Technology, Faculty of Pharmacy, International Islamic University Malaysia (IIUM), Pahang, Malaysia

DOI:

https://doi.org/10.31436/jop.v2i2.119

Keywords:

scale up, pilot scale, manufacturing, piper betle, cosmetic cream

Abstract

Introduction: The objective of this study was to scale up a natural based cream containing Piper betle L. extract to pilot scale and asses it’s stability over time. Method: During the scale up process, the critical process parameters (CPP) were monitored closely to ensure the critical quality attributes (CQA) are maintained within a desired range. To ensure the formulation was stable, a 6-months stability study was done where the organoleptic properties, particle size, zeta potential, viscosity, microbial limit and hydroxchavicol content were assessed. The formulation was characterized repeatedly at 0-month, 1-month, 2-month, 3-month and 6-month time point after being stored in 30°C±2 and 40°C±2 at 75%±5% RH. Results: CPPs in each process were maintained at certain values throughout to achieve CQAs. Time, speed and temperature during mixing and homogenization process were monitored and maintained. Stability study over 6 months proved the ability of the product to remain stable with pH < 5, particle size < 2µm, low span value, zeta potential < -50mV, apparent viscosity < 1.2Pa.s­¹ and no microbial growth. Conclusion: In conclusions, CPPs played a major role in enabling the formulation produced attain acceptable CQAs. Identifying CQA and CPP ensured the production of quality and stable product.

References

Adeyeye, M. C., Jain, A. C., Ghorab, M. K. M., & Reilly, W. J. (2002). Viscoelastic Evaluation of Topical Creams Containing Microcrystalline Cellulose/Sodium Carboxymethyl Cellulose as Stabilizer. AAPS PharmSciTech, 3(2), 16–25.

Ahmed, K., Li, Y., McClements, D. J., & Xiao, H. (2012). Nanoemulsion- and Emulsion-based Delivery Systems for Curcumin: Encapsulation and Release Properties. Food Chemistry, 132(2), 799–807.

Ali, A., Chong, C., Mah, S., Abdullah, L., Choong, T., Chua, B., Ali, A., Chong, C. H., Mah, S. H., Abdullah, L. C., Choong, T. S. Y., & Chua, B. L. (2018). Impact of Storage Conditions on the Stability of Predominant Phenolic Constituents and Antioxidant Activity of Dried Piper betle Extracts. Molecules, 23(2), 484.

Ali, S., & Yosipovitch, G. (2013). Skin pH: From Basic Science to Basic Skin Care. Acta Dermato Venereologica, 93(3), 261–267.

Arti, P., Manish, S., & Kalpana, P. (2014). Formulation and Evaluation of Poly Herbal Cream. International Journal of Pharmaceutical and Biological Archives, 5(4), 67–71.

Association of Southeast Asian Nations (ASEAN). (2013). ASEAN Guideline on Stability Study of Drug Product.

BahramParvar, M., & Goff, H. (2013). Basil Seed Gum as a Novel Stabilizer for Structure Formation and Reduction of Ice Recrystallization in Ice Cream. Dairy Science & Technology, 93(3), 273–285.

Charles, C. A. D., & McLean, S. K. (2017). Body Image Disturbance and Skin Bleaching. British Journal of Psychology, 108(4), 783–796.

Contri, R. V., Katzer, T., Ourique, A. F., da Silva, A. L. M., Beck, R. C. R., Pohlmann, A. R., & Guterres, S. S. (2014). Combined Effect of Polymeric Nanocapsules and Chitosan Hydrogel on the Increase of Capsaicinoids Adhesion to the Skin Surface. Journal of Biomedical Nanotechnology, 10(5), 820–830.

Cosmetic Toiletry and Fragrance Association (CTFA). (2004). Cosmetics Europe: Guideline on Stability Testing of Cosmetics Products.

Desai, S. R. (2014). Hyperpigmentation Therapy: A Review. The Journal of Clinical and Aesthetic Dermatology, 7(8), 13–17.

Deuschle, V. C. K. N., Deuschle, R. A. N., Bortoluzzi, M. R., Athayde, M. L., Deuschle, V. C. K. N., Deuschle, R. A. N., Bortoluzzi, M. R., & Athayde, M. L. (2015). Physical Chemistry Evaluation of Stability, Spreadability, In vitro Antioxidant, and Photo-protective Capacities of Topical Formulations Containing Calendula officinalis L. Leaf Extract. Brazilian Journal of Pharmaceutical Sciences, 51(1), 63–75.

Esteban, P. P., Jenkins, A. T. A., & Arnot, T. C. (2016). Elucidation of the Mechanisms of Action of Bacteriophage K/Nano-Emulsion Formulations Against S. aureus via Measurement of Particle Size and Zeta Potential. Colloids and Surfaces B: Biointerfaces, 139, 87–94.

Euromonitor. (2016). Statistics. http://www.euromonitor.com/skin-care

European Comission. (2009). Regulation (EC) No1223/2009 of The European Parliament and of The Council. Official Journal of The European Union, 1223, 342–359.

European Medicines Agency (EMA). (2016). Guideline on Process Validation for Finished Products - Information and Data to be Provided in Regulatory Submissions. (EMA/CHMP/CVMP/QWP/749073/2016).

Fernandes, G. D., Alberici, R. M., Pereira, G. G., Cabral, E. C., Eberlin, M. N., & Barrera-Arellano, D. (2012). Direct Characterization of Commercial Lecithins by Easy Ambient Sonic-spray Ionization Mass Spectrometry. Food Chemistry, 135(3), 1855–1860.

Ghosh, V., Mukherjee, A., & Chandrasekaran, N. (2013). Ultrasonic Emulsification of Food-grade Nanoemulsion Formulation and Evaluation of its Bactericidal Activity. Ultrasonics Sonochemistry, 20(1), 338–344.

Gibson, M. (Ed.). (2016). Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form. CRC Press.

Goyal, A., Sharma, V., Upadhyay, N., Singh, A. K., Arora, S., Lal, D., & Sabikhi, L. (2015). Development of Stable Flaxseed Oil Emulsions as a Potential Delivery System of ?-3 Fatty Acids. Journal of Food Science and Technology, 52(7), 4256–4265.

Henderson, N. L., Meer, P. M., & Kostenbauder, H. B. (1961). Approximate Rates of Shear Encountered in Some Pharmaceutical Processes. Journal of Pharmaceutical Sciences, 50(9), 788–791.

Honary, S., & Zahir, F. (2013). Effect of Zeta Potential on the Properties of Nano-Drug Delivery Systems - A Review (Part 1). Tropical Journal of Pharmaceutical Research, 12(2), 255–264.

International Conference on Harmonisation (ICH). (2003). Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products. 301–827.

International Conference on Harmonisation (ICH). (2009). Pharmaceutical Development Q8 (R2). ICH Harmonised Tripartite Guideline, 8(August), 1–28.

Khan, B. A., Akhtar, N., Khan, H., & Braga, V. de A. (2013). Development, Characterization and Antioxidant Activity of Polysorbate Based O/W Emulsion Containing Polyphenols Derived from Hippophae Rhamnoides and Cassia fistula. Brazilian Journal of Pharmaceutical Sciences, 49(4), 763–773.

Khor, Y. P., Koh, S. P., Long, K., Long, S., Ahmad, S. Z. S., & Tan, C. P. (2014). A Comparative Study of the Physicochemical Properties of a Virgin Coconut Oil Emulsion and Commercial Food Supplement Emulsions. Molecules, 19(7), 9187–9202.

Kirtil, E., & Oztop, M. H. (2016). Characterization of Emulsion Stabilization Properties of Quince Seed Extract as a New Source of Hydrocolloid. Food Research International, 85, 84–94.

Krstonoši?, V., Doki?, L., Nikoli?, I., & Milanovi?, M. (2015). Influence of Xanthan Gum on Oil-in-water Emulsion Characteristics Stabilized by OSA Starch. Food Hydrocolloids, 45, 9–17.

Long, Z., Zhao, M., Zhao, Q., Yang, B., & Liu, L. (2012). Effect of Homogenisation and Storage Time on Surface and Rheology Properties of Whipping Cream. Food Chemistry, 131(3), 748–753.

Lu, G. W., & Gao, P. (2010). Emulsions and Microemulsions for Topical and Transdermal Drug Delivery. In Handbook of Non-Invasive Drug Delivery Systems (pp. 59–94). Elsevier.

Lueng, E. (2019, September 20). Top Trends Shaping APAC’s Skin Care Industry. Euromonitor. https://www.euromonitor.com/article/top-trends-shaping-apacs-skin-care-industry

Mahmood, Z., Imam, S., & Azhar, I. (2015). In vitro Evaluation of Sun Protection Factor (SPF) of a Cream Formulation Prepared From Extracts of Musa accuminata (L.), Psidium gujava (L.), and Pyrus communis (L.). Asian Journal of Pharmaceutical and Clinical Research, 8(3), 234–237.

Majeed, M., Bani, S., Pandey, A., & Anand-Tathapudi, S. (2012). Composition and a Method of Treating CNS Disorders and Hyperpigmentation (Patent No. 12/900,727). U.S. Patent Application No. 12/900,727.

Niu, F., Niu, D., Zhang, H., Chang, C., Gu, L., Su, Y., & Yang, Y. (2016). Ovalbumin/Gum Arabic-Stabilized Emulsion: Rheology, Emulsion Characteristics, and Raman Spectroscopic study. Food Hydrocolloids, 52, 607–614.

Omar, S. S. S., Hadi, H., Hanif, N. M., Ahmad, H. M. A., & Ng, S.-F. (2021). Lightening Effect of Skin Lightening Cream Containing Piper betle L. Extract in Human Volunteers. Cosmetics 2021, Vol. 8, Page 32, 8(2), 32.

Oudenhoven, M. D., Kinney, M. A., McShane, D. B., Burkhart, C. N., & Morrell, D. S. (2015). Adverse Effects of Acne Medications: Recognition and Management. American Journal of Clinical Dermatology, 16(4), 231–242.

Pradhan, D., Suri, K. A., Pradhan, D. K., & Biswasroy, P. (2013). Golden Heart of the Nature: Piper betle L . Journal of Pharmacognosy and Phytochemistry, 1(6), 147–167.

Rodrigues, F., Sarmento, B., Amaral, M. H., & Oliveira, M. B. P. P. (2016). Exploring the Antioxidant Potentiality of Two Food By-products into a Topical Cream: Stability, In vitro and In vivo Evaluation. Drug Development and Industrial Pharmacy, 42(6), 880–889.

Saberi, A. H., Fang, Y., & McClements, D. J. (2013). Fabrication of Vitamin E-enriched Nanoemulsions: Factors Affecting Particle Size Using Spontaneous Emulsification. Journal of Colloid and Interface Science, 391, 95–102.

Salkar, V., & Tembhurkar, A. (2016). Experimental evaluation of ripening behavior: Down-Flow vs. Up-Flow rapid sand filters. KSCE Journal of Civil Engineering, 20(4), 1221–1227.

Santos, J. L., & Gaspar, F. (2018). Production of Near Monodisperse Particles Using Milling and Membrane Separation (Patent No. US9937470B2).

Saraf, S., Sahu, S., Kaur, C. D., & Saraf, S. (2010). Comparative Measurement of Hydration Effects of Herbal Moisturizers. Pharmacognosy Research, 2(3), 146–151.

Singh, V. K., Nandi, M. K., & Singh, N. K. (2016). Accelerated Stability Study of Chitrak Haritaki Avaleha. International Journal of Pharmacy and Pharmaceutical Sciences, 8(2), 221–223.

Singtongratana, N., Vadhanasin, S., & Singkhonrat, J. (2013). Hydroxychavicol and Eugenol Profiling of Betel Leaves from Piper betle L. Obtained by Liquid-Liquid Extraction and Supercritical Fluid Extraction. Journal of Natural Science, 47, 614–623.

Smaoui, S., Ben Hlima, H., Ben Chobba, I., & Kadri, A. (2013). Development and Stability Studies of Sunscreen Cream Formulations Containing Three Photo-protective Filters. Arabian Journal of Chemistry, 10, 1216–1222.

Smaoui, S., Hlima, H., Jarraya, R., & Kamoun, N. (2012). Cosmetic Emulsion from Virgin Olive Oil: Formulation and Bio-physical Evaluation. African Journal of Biotechnology, 11(40), 9664–9671.

Terjung, N., Löffler, M., Gibis, M., Hinrichs, J., & Weiss, J. (2012). Influence of Droplet Size on the Efficacy of Oil-in-water Emulsions Loaded with Phenolic Antimicrobials. Food Funct., 3(3), 290–301.

United States Pharmacopeia. (2014a). Microbiological examination of nonsterile products: microbial enumeration tests. USP 37, chapter 61.

United States Pharmacopeia. (2014b). Microbiological examination of nonsterile products: tests for specified microorganisms. USP 37, chapter 62.

U.S Congress. (1934). United States Code: Federal Food, Drug and Cosmetic Act, 21 U.S.C.

U.S. Department of Health and Human Services Food and Drug Administration (FDA). (2011). Guidance for Industry Process Validation: General Principles and Practices. 20852–21448.

Downloads

Published

2022-07-31

How to Cite

Syed Omar, S. S., Ab Hadi, H., & Doolaanea, A. A. (2022). Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) Roles in the Pilot Scale up Process and Stability of a Cosmetic Cream. Journal of Pharmacy, 2(2), 45–58. https://doi.org/10.31436/jop.v2i2.119

Issue

Section

Original Articles

Most read articles by the same author(s)