JOURNAL OF THE CZECH PHARMACEUTICAL SOCIETY AND THE SLOVAK PHARMACEUTICAL SOCIETY

Čes. slov. farm. 2020, 69(1):33-42 | DOI: 10.36290/csf.2020.004

Development and uniformity evaluation of low-dose medicated chewing gums prepared by compression method

Yuliia Maslii1,*, Olena Ruban1, Olga Yevtifieieva2, Volodymyr Hrudko2, Svitlana Gureyeva3, Andriy Goy3, Tetiana Kolisnyk1
1 Department of Industrial Technology of Drugs, National University of Pharmacy, Kharkiv, Ukraine
2 Department of Pharmaceutical Chemistry, National University of Pharmacy, Kharkiv, Ukraine
3 JSC Farmak, Kyiv, Ukraine

The aim of this work was to develop medicated chewing gums (MCGs) containing 10 mg of lysozyme hydrochloride (LH) and 20 mg of ascorbic acid (AsA) obtained by the compression method with Health in Gum® (HiG®) PWD 01 as a compressible gum base. Because of a low content of active ingredients, it was essential to choose the way of adding them to the tableting mass and evaluate their distribution homogeneity in the dosage units. The blends for compression were prepared by two methods: the first one was simple mixing of all components; the second one included the step of wet granulation of a three-component mixture - LH, sucralose and a taste additive. Flow properties of LH, AsA, HiG®, LH granules and blends for compression were studied. MCGs were evaluated according to Ph.Eur. 9.0 Chapters 2.9.5, 2.9.6 and 2.9.40. AsA and HiG® were characterized as free flowing, while LH had insufficient flow properties. Compared with a simple mixed blend, the granulation step allowed significantly improving flow properties of the final blend for compression. Unlike MCGs compressed from the simple mixed blend, MCGs prepared through the granulation step met Ph.Eur. 9.0 Chapter 2.9.40 requirements. The propriety of MCG preparation method involving the step of wet granulation also has been confirmed by mass and drug content uniformity tests.

Keywords: ascorbic acid; medicated chewing gums; lysozyme hydrochloride; mass uniformity; drug content uniformity; uniformity of dosage units

Received: September 4, 2019; Accepted: December 5, 2019; Published: January 1, 2020  Show citation

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Maslii Y, Ruban O, Yevtifieieva O, Hrudko V, Gureyeva S, Goy A, Kolisnyk T. Development and uniformity evaluation of low-dose medicated chewing gums prepared by compression method. Čes. slov. farm. 2020;69(1):33-42. doi: 10.36290/csf.2020.004.
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    References

    1. Al Hagbani T., Nazzal S. Medicated Chewing Gums (MCGs): Composition, Production, and Mechanical Testing. AAPS PharmSciTech. 2018; 19(7): 2908-2920. Go to original source... Go to PubMed...
    2. Aslani A., Rostami F. Medicated chewing gum, a novel drug delivery system. J. Res. Med. Sci. 2015; 20(4): 403-411. Go to original source...
    3. Chaudhary S. A., Shahiwala A. F. Medicated chewing gum - a potential drug delivery system. Expert Opin. Drug Deliv. 2010; 7(7): 871-885. Go to original source... Go to PubMed...
    4. Dodds M. W. The oral health benefits of chewing gum. J. Ir. Dent. Assoc. 2012; 58(5): 253-261. Go to original source... Go to PubMed...
    5. Itthagarun A, Wei S. H. Chewing gum and saliva in oral health. J. Clin. Dent. 1997; 8(6): 159-162.
    6. Wessel S. W., van der Mei H. C., Maitra A., Dodds M. W., Busscher H. J. Potential benefits of chewing gum for the delivery of oral therapeutics and its possible role in oral healthcare. Expert Opin. Drug Deliv. 2016; 13(10): 1421-1431. Go to original source... Go to PubMed...
    7. Ogundele M. O. A novel anti-inflammatory activity of lysozyme: modulation of serum complement activation. Mediators Inflamm. 1998; 7(5): 363-365. Go to original source... Go to PubMed...
    8. Ragland S. A., Criss A. K. From bacterial killing to immune modulation: Recent insights into the functions of lysozyme. PLoS Pathog. 2017; 13(9): e1006512. Go to original source... Go to PubMed...
    9. Zhang X., Wu F. X., Sun M., Wang Q. Y., Wang Y. J., Yang X. K. Study on antimicrobial and antiviral activities of lysozyme from marine strain S-12-86 in vitro. Agric. Sci. China 2008; 7(1): 112-116. Go to original source...
    10. Krzyściak W., Jurczak A., Piątkowski J., Kościelniak D., Gregorczyk-Maga I., Kołodziej I., Papież M. A., Olczak-Kowalczyk D. Effect of histatin-5 and lysozyme on the ability of Streptococcus mutans to form biofilms in vitro conditions. Postepy Hig. Med. Dosw. 2015; 69: 1056-1066.
    11. Moslemi M., Sattari M., Kooshki F., Fotuhi F., Modarresi N., Khalili Sadrabad Z., Shadkar M. S. Relationship of salivary lactoferrin and lysozyme concentrations with early childhood caries. J. Dent. Res. Dent. Clin. Dent. Prospects 2015; 9(2): 109-114. Go to original source... Go to PubMed...
    12. Karami-Nogourani M., Kowsari-Isfahan R., Hosseini-Beheshti M. The effect of chewing gum's flavor on salivary flow rate and pH. Dent. Res. J. (Isfahan) 2011; 8(Suppl 1): S71-S75. Go to original source... Go to PubMed...
    13. Padayatty S. J., Levine M. Vitamin C: the known and the unknown and Goldilocks. Oral Dis. 2016; 22(6): 463-493. Go to original source... Go to PubMed...
    14. Lingström P., Fure S., Dinitzen B., Fritzne C., Klefbom C., Birkhed D. The release of vitamin C from chewing gum and its effects on supragingival calculus formation. Eur. J. Oral Sci. 2005; 113(1): 20-27. Go to original source... Go to PubMed...
    15. Kása P., Jójárt I., Kelemen A., Pintye-Hódi K. Formulation study of directly compressible chewable polymers containing ascorbic acid. Pharm. Dev. Technol. 2013; 18(2): 384-389. Go to original source... Go to PubMed...
    16. Meeus L. Direct compression versus granulation. Pharm. Technol. Eur. 2011; 23: 21-22.
    17. Gryzodub O. I., Leontiev D. A., Levin M. G., Asmolova N. N., Vyrova H. V. Realization of "Content uniformity" and "Dissolution" tests by chromatographic methods under production quality control. J. Org. Pharm. Chem. 2004; 2(1): 24-34. Russian.
    18. Hoag S. W. Capsules dosage form: Formulation and manufacturing considerations. In: Developing Solid Oral Dosage Forms, 2nd ed. Qiu Y., Chen Y., Zhang G. G. Z., et al. (eds.) Academic Press 2017; 723-747. Go to original source...
    19. Jójárt I., Kása P. Jr, Kelemen A., Pintye-Hódi K. Study of the compressibility of chewing gum and its applicability as an oral drug delivery system. Pharm. Dev. Technol. 2016; 21(3): 321-327. Go to original source... Go to PubMed...
    20. Pavlovska G, Tanevska S. Influence of temperature and humidity on the degradation process of ascorbic acid in vitamin C chewable tablets. J. Therm. Anal. Calorim. 2013; 111(3): 1971-1977. Go to original source...
    21. Council of Europe. European Pharmacopoeia, 9th edition, Strasbourg: Council of Europe 2016.
    22. Muselík J., Franc A., Štarková J., Matějková Z. Optimization of technological processes for the preparation of tablets with a low content of warfarin by direct compression. Čes. slov. Farm. 2014; 63: 217-221. Go to original source...
    23. Alyami H., Dahmash E., Bowen J., Mohammed A. R. An investigation into the effects of excipient particle size, blending techniques and processing parameters on the homogeneity and content uniformity of a blend containing low-dose model drug. Pharm. Dev. Technol. 2009; 14(5): 451-460.
    24. Elbl J., Muselík J., Franc A., Mikušová J., Dolejší Z., Vetchý D. Influence of drug concentration and blending technology on the content uniformity of mixture for low dose warfarin tablets. Čes. slov. Farm. 2016; 65(6): 211-215. Go to original source...
    25. am Ende M. T., Moses S. K., Carella A. J., Gadkari R. A., Graul T. W., Otano A. L., et al. Improving the content uniformity of a low-dose tablet formulation through roller compaction optimization. Pharm. Dev. Technol. 2007; 12(4): 391-404. Go to original source... Go to PubMed...
    26. Morris D. G., Truitt B. F., Kong A., Leyva N., Luner P. E. Influence of formulation composition and processing on the content uniformity of low-dose tablets manufactured at kilogram scale. Pharm. Dev. Technol. 2009; 14(5): 451-460. Go to original source... Go to PubMed...
    27. Özlem Akbal, Erdal Cevher, Ahmet Oğul Araman. The development and in vitro evaluation of benzydamine hydrochloride medicated chewing gum formulations. Istanbul J. Pharm. 2017; 47(2): 45-51. Go to original source...
    28. Ranmale J. S., Thombre N. A., Kshirsagar S. J., Aher A. S. Formulation development and evaluation of amoxicillin based medicated chewing gum. Indian Journal of Novel Drug Delivery 2015; 7(3): 108-115.
    29. Mansi Paradkar, Balaram Gajra, Bhautik Patel. Formulation development and evaluation of medicated chewing gum of anti-emetic drug. Saudi Pharm. J. 2016; 24: 153-164. Go to original source... Go to PubMed...

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