The Potential of Allanblackia floribunda Butter as a Suppository Base

Document Type : Original Article

Authors

1 Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, Kwame Nkrumah University of Science and Technology, Ghana

2 Forestry Research Institute, Centre for Scientific and Industrial Research, Fumesua, Kumasi, Ghana.

10.30476/tips.2024.100473.1217

Abstract

The rectal route for drug administration is becoming attractive to drug formulators because there are no hepatic first-pass effects, it decreases gastrointestinal side effects, and it avoids undesirable food effects on drug absorption. Suppositories are recognized as an alternative to the oral dosage forms in situations such as when the patient is comatose, unable to swallow, nauseous, or vomiting. Effective drug delivery with appropriate pharmaceutical excipients is critical to producing clinically valuable preparations. The high cost of available excipients and other disadvantages have led to exploring potential excipients from natural sources. Allanblackia floribunda butter, a naturally occurring lipid, is used for medicinal, culinary, and cosmetic purposes. The butter was used as a base to formulate Paracetamol and Diclofenac suppositories. Quality control tests were conducted on the formulated suppositories, such as the Weight variation, hardness, disintegration time, and content uniformity. The suppositories passed all the quality control tests as the parameters assessed were within the acceptable range. The melting point ranges for all the suppositories were found to be satisfactory. The cumulative drug release (%) of the suppositories at 45 minutes was 90.19±0.00 (Hot water extract), 93.75±0.00 (Cold press extract), and 98.16±0.00 (Hexane extract) for Paracetamol suppositories. Diclofenac sodium suppositories had a cumulative percentage release of 81.60±0.00 (Hot water Extract), 95.33±0.00 (Cold press extract), and 99.20±0.00 (Hexane Extract). However, the release profiles of the drugs from the bases were similar (f2 > 50). The suppository formulation was successful, and the quality control tests conformed to Pharmacopoeia standards.

Highlights

Frederick William Akuffo Owusu (Google Scholar)

Keywords


1.    Mehanna MM, Mneimneh AT. Formulation and Applications of Lipid-Based Nanovehicles: Spotlight on Self-emulsifying Systems. Adv Pharm Bull. 2021 Jan;11(1):56-67. doi: 10.34172/apb.2021.006. Epub 2020 Nov 7. PMID: 33747852; PMCID: PMC7961215.
2.    D. K. Surender Verma, Anupama Baghotia, Jitender Singh, Kamal Saroha, Sunil Kumar, “Pharmaceutical Excipients: A Regulatory Aspect,” Pharma Innov. J., vol. 5, no. 5, p. 124, 2016, Accessed: Jul. 07, 2022. [Online]. Available: https://www.thepharmajournal.com/archives/?year=2016&vol=5&issue=6&ArticleId=835.
3.    G. Gallego, “Definition of Pharmaceutical Excipients - pharma excipients,” no. C. pp. 1–6, 2022, Accessed: Dec. 28, 2022. [Online]. Available: https://www.pharmaexcipients.com/pharmaceutical-excipients-some-definition/.
4.    Abedi E, Sahari MA. Long-chain polyunsaturated fatty acid sources and evaluation of their nutritional and functional properties. Food Sci Nutr. 2014 Sep;2(5):443-63. doi: 10.1002/fsn3.121. Epub 2014 Jun 29. PMID: 25473503; PMCID: PMC4237475.
5.    Ansel’s Pharmaceutical Dosage Forms and Drug Delivery System, 9th Edition | Eman Hamdy - Academia.edu.” https://www.academia.edu/40571341/Ansels_Pharmaceutical_Dosage_Forms_and_Drug_Delivery_System_9th_Edition (accessed Jul. 07, 2022).
6.    Pharmaceutics The Science of Dosage Form Design 2Ed M.E.Aulton v | maharun Nessa - Academia.edu.” https://www.academia.edu/37211563/Pharmaceutics_The_Science_of_Dosage_Form_Design_2Ed_M_E_Aulton_v (accessed Jul. 07, 2022).
7.    M. O. Israel, “Effects of Topical and Dietary Use of Shea Butter on Animals,” Am. J. Life Sci., vol. 2, no. 5, p. 303, 2014, DOI: 10.11648/j.ajls.20140205.18.
8.    Bartels DA, Johnson R, Bayor MT, Ainooson GK, Ossei PPS, Etuaful RK, et al. Formulation of Suppositories of Alum Produced from Bauxite Waste in Ghana for the Treatment of Hemorrhoid. ScientificWorldJournal. 2021 May 12;2021:6667562. doi: 10.1155/2021/6667562. PMID: 34093089; PMCID: PMC8137290.
9.    Magrone T, Russo MA, Jirillo E. Cocoa and Dark Chocolate Polyphenols: From Biology to Clinical Applications. Front Immunol. 2017 Jun 9;8:677. doi: 10.3389/fimmu.2017.00677. PMID: 28649251; PMCID: PMC5465250.
10.    K. Roth, “Chocolate – The Noblest Polymorphism III,” ChemViews, 2010, DOI: 10.1002/chemv.201000031.
11.    R. Peschar, M. M. Pop, D. J. A. De Ridder, J. B. Van Mechelen, R. A. J. Driessen, and H. Schenk, “Crystal structures of 1,3-distearoyl-2-oleoylglycerol and cocoa butter in the β(V) phase reveal the driving force behind the occurrence of fat bloom on chocolate,” J. Phys. Chem. B, vol. 108, no. 40, pp. 15450–15453, Oct. 2004, DOI: 10.1021/JP046723C.
12.    P. D. Amin, B. T. Raimi-Abraham, D. S. Shah, and S. Gurram, “Medicated topicals,” in Remington: The Science and Practice of Pharmacy, Elsevier, 2020, pp. 381–393.
13.    M. Konadu, Formulation of Suppositories using Allanblackia floribunda butter as a Base, MSc Thesis. KNUST, 2022.
14.    W. Sefah, J. Adubofuor, and J. H. Oldham, “Optimum conditions for expression of oil from Allanblackia floribunda seeds and assessing the quality and stability of pressed and solvent extracted oil,” African J. Food Sci., vol. 4, no. 9, pp. 563–570, 2010, Accessed: Mar. 04, 2022. [Online]. Available: https://www.researchgate.net/publication/262923693_Optimum_conditions_for_expression_of_oil_from_Allanblackia_floribunda_seeds_and_assessing_the_quality_and_stability_of_pressed_and_solvent_extracted_oil.
15.    D. Turck et al., “Safety of Allanblackia seed oil for extended uses in vegetable oils and milk and in yellow fat and cream-based spreads up to 30% (w/w),” EFSA J., vol. 16, no. 8, p. e05362, Aug. 2018, DOI: 10.2903/j.efsa.2018.5362.
16.    “Cooper and Gunn’s Dispensing for Pharmaceutical Students 12th edition by Carter (2008) Paperback: Amazon.com: Books.” https://www.amazon.com/Cooper-Dispensing-Pharmaceutical-Students-Paperback/dp/B011MF54C0 (accessed Jul. 07, 2022).
17.    “The British Pharmacopoeia - British Pharmacopoeia,” www.pharmacopoeia.com. 2019, Accessed: Jul. 09, 2022. [Online]. Available: https://www.pharmacopoeia.com/the-british-pharmacopoeia.
18.    Kale VV, Trivedi RV, Wate SP, Bhusari KP. Development and evaluation of a suppository formulation containing Lactobacillus and its application in vaginal diseases. Ann N Y Acad Sci. 2005 Nov;1056:359-65. doi: 10.1196/annals.1352.017. PMID: 16387701.
19.    S. Kaewnopparat and N. Kaewnopparat, “Formulation and evaluation of vaginal suppositories containing lactobacillus,” Int. J. Pharmacol. Pharm. Sci., vol. 3, no. 7, pp. 117–120, 2009, Accessed: Jul. 09, 2022. [Online]. Available: https://www.semanticscholar.org/paper/Formulation-and-Evaluation-of-Vaginal-Suppositories-Kaewnopparat-Kaewnopparat/a0ac3d899ab0c1e69adda504eed6d8138952b080.
20.    In vitro release of paracetamol from Suppocire Suppositories: role of additives.” https://www.researchgate.net/publication/272181993_In_vitro_release_of_paracetamol_from_Suppocire_Suppositories_role_of_additives (accessed Jul. 09, 2022).
21.    United States Pharmacopeial Convention, “USP 40–NF 35 | USP-NF,” 2017. https://www.uspnf.com/official-text/proposal-statuscommentary/usp-40-nf-35 (accessed Mar. 16, 2022).
22.    Kao FJ, Chiu YS, Chiang WD. Effect of water cooking on antioxidant capacity of carotenoid-rich vegetables in Taiwan. J Food Drug Anal. 2013 Oct 5;22(2):202–9. doi: 10.1016/j.jfda.2013.09.010. PMCID: PMC9359331.
23.    J. Adubofuor, "Nutrient composition of Allanblackia Paviflora seed kernels and oil compared with some plant fats and oils and oil application in soap preparation," J. Cereal. Oilseeds, vol. 4, no. 1, pp. 1–9, Feb. 2013, DOI: 10.5897/jco12.020.
24.    British Pharmacopoeia 2017 Vol. II HMSO. .
25.    H. G. Ferraz, L. N. Carpentieri, and S. P. Watanabe, “Dissolution profile evaluation of solid pharmaceutical forms containing chloramphenicol marketed in Brazil,” Brazilian Arch. Biol. Technol., vol. 50, no. 1, pp. 57–65, 2007, DOI: 10.1590/S1516-89132007000100007.
26.    Fernandes C, Junqueira RG, Campos LM, Pianetti GA. Dissolution test for lamivudine tablets: optimization and statistical analysis. J Pharm Biomed Anal. 2006 Nov 16;42(5):601-6. doi: 10.1016/j.jpba.2006.05.009. Epub 2006 Jun 22. PMID: 16797911.
27.    J. E. Polli, G. S. Rekhi, L. L. Augsburger, and V. P. Shah, “Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets,” J. Pharm. Sci., vol. 86, no. 6, pp. 690–700, 1997, DOI: 10.1021/JS960473X.
28.    Kassaye L, Genete G. Evaluation and comparison of in-vitro dissolution profiles for different brands of amoxicillin capsules. Afr Health Sci. 2013 Jun;13(2):369-75. doi: 10.4314/ahs.v13i2.25. PMID: 24235938; PMCID: PMC3824474.