The development and in vitro evaluation of benzydamine hydrochloride medicated chewing gum formulations

Year 2017, , 45 - 51, 18.10.2017

Özlem Akbal Erdal Cevher Ahmet Oğul Araman

https://doi.org/10.5152/IstanbulJPharm.2017.007

Abstract

The objective of this study was to develop
a chewing gum formulation for benzydamine hydrochloride (BN) and evaluate the
effect of different co-compression agents on physicochemical parameters and in
vitro drug release profile. BN has been utilized in symptomatic treatment  for pain and irritations of the mouth and
throat. Chewing gum formulations of BN were produced using direct compression
method. In fabricated chewing gums, except pharmacopeia analysis, physical and
structural analysis like thickness, weight variation, elasticity and
compressibility were evaluated. The release of BN from the gum was studied
using the chewing apparatus which have been designed for procuring the release
of BN from the chewing gum.The quantity of BN present in the chewing gum and
the release medium were quantified by spectrophotometric method. Gum formulations
showed promising in vitro release profiles, in which 80–90% BN was released in
a sustained manner over 20 min of chewing time. In addition, it was observed
that the drug release was fitted into matrix diffusion kinetic and revealed a
non-Fickian drug release mechanism. This study suggests that BN in a gum
formulation  is a suitable dosage form
for the delivery in the oral cavity, thereby and serving as an instant
analgesic.

Keywords

Benzydamine hydrochloride, medicated chewing gum, mastication apparatus

References

• REFERENCES • Abelson DC, Barton J, Mandel ID (1990). The effect of chewing sorbitol-sweetened gum on salivary flow and cemental plaque pH in subjects with low salivary flow. J Clin Dent 2: 3-5. PMid:2133392 • Andersen T, Gram-Hansen M, Pedersen M, Rassing MR (1990). Chewing gum as a drug delivery system for nystatin influence of solubilising agents upon the release of water insoluble drugs. Drug Dev Ind Pharm 16: 1985-1994. https://doi.org/10.3109/03639049009023636
• • Cherukuri SR, Pinney JM, Henningfield JE, Sasan A, Cone EJ, Shiffman S, Gitchell J, Malvestutto CD (2000). Medicated Chewing Gum Delivery System for Nicotine. US Patent No 6344222: 1-24. • Dodds MWJ, Hsieh SC, Johnson DA (1991). The effect on increased mastication by daily gum-chewing on salivary gland output and dental plaque acidogenicity. J Dent Res 70: 1474-1478. https://doi.org/10.1177/00220345910700120101 PMid:1774376 • Dong HN, Jabar F, Yilmaz C, Kai PL, DeLuca PP (2005). Chewing gum of antimicrobial decapeptide (KSL) as a sustainedcantiplaque agent. Preformulation study. J Control Release 107: 122-130. https://doi.org/10.1016/j.jconrel.2005.05.027 PMid:16009443 • Eisenstadt B, Cash AP, Bakal IA (1998). Chewing gum containing cough suppression agent. US Patent No 5,846,557. • European Pharmacopoeia, 9th edition. • Gajendran J, Kraemer J, Knudsen SR (2008). Product Performance Test for Medicated Chewing Gums.Pharmacopeial Forum 34: 15-18. • Herrera D (2005). Efficacy of a 0.15% benzydamine hydrochloride and 0.05% cetylpyridinium chloride mouth rinse on 4-day de novo plaque formation. J Clin Periodontol 32: 595-603. https://doi.org/10.1111/j.1600-051X.2005.00718.x PMid:15882217 • Kvist LC, Andersson SB, Berglund J, Wennergren B, Fors SM (2000). Equipment for drug release testing of medicated chewing gums. J Pharm Biomed Anal 22: 405-411. https://doi.org/10.1016/S0731-7085(99)00307-6
• • Liljewall LR (1992). Apparatus for mechanical processing of a sample and a member of such an apparatus.US Patent No 5,087424. • Maggi L, Segale L, Conti S, Ochoa-Machiste E, Salini A, Conte U (2005). Preparation and evaluation of release characteristics of 3TabGum, a novel chewing device. Eur J Pharm Sci 24: 487-493. https://doi.org/10.1016/j.ejps.2005.01.010 PMid:15784338 • Mehta F, Trivedi P (2011). Formulation and texture characterization of medicated chewing gum delivery of dimenhydrinate hydrochloride. Pharm Lett 3:179-192. • Morjaria M, Irwin WJ, Barnett PX, Chan RS, Conway BR (2009). In vitro release of nicotine from chewing gum formulations. Dissolution Technol 5: 12-15. • Mostafavi SA, Varshosaz J, Arabian S (2014). Formulation development and evaluation of metformin chewing gum with bitter taste masking. Adv Biomed Res 25: 92. https://doi.org/10.4103/2277-9175.129362 PMid:24800181 PMCid:PMC4007337 • Nagaich U, Chaudhary V, Karki R, Yadav A, Sharma P (2010). Formulation of medicated chewing gum of ondansetron hydrochloride and its pharmacokinetic evaluations. Int J Pharm Sci Res 1: 32-40. • Noehr-Jensen L, Damkier P, Bidstrup TB, Pedersen RS, Nielsen F, Brosen K (2006). The relative bioavailability of loratadine administered as a chewing gum formulation in healthy volunteers. Eur J Clin Pharmacol 62: 437-445. https://doi.org/10.1007/s00228-006-0139-6 PMid:16770647 • Pedersen M, Rassing MR (1990). Miconazole chewing gum as a drug delivery system application of solid dispersion technique and lecithin. Drug Dev Ind Pharm 16: 2015-2030. https://doi.org/10.3109/03639049009023638 https://doi.org/10.3109/03639049009115986 https://doi.org/10.3109/03639049009023637
• • Peppas NA. (1985) Analysis of Fickian and non-fickian drug release from polymers. Pharm Acta Helv 60:110-111. PMid:4011621 • Rassing MR (1992). Chewing gum as drug delivery system. Adv Drug Deliv Rev 13: 89-121. https://doi.org/10.1016/0169-409X(94)90028-0
• • Rassing MR, Jacobsen J, Nielsen HM (2003). Chewing gum as a drug delivery system. 2th ed, Ellermann Carecom International, Denmark. • Rathbone MJ, Hadgraft J, Roberts MS (2002). Modified-release drug delivery technology. New York: Marcel Dekker: 1-8. https://doi.org/10.1201/9780203910337
• • Rowe RC (2003). By gum- a buccal delivery system. Drug Delivery Today 8: 617-618. https://doi.org/10.1016/S1359-6446(03)02728-4
• • Stojanov M, Larsen KL (2012). Cetirizine release from cyclodextrin formulated compressed chewing gum. Drug Dev Ind Pharm 38: 1061-1067. https://doi.org/10.3109/03639045.2011.638301 PMid:22185653 • Swamy NGN, Rupa V, Abbas Z, Dasankoppa FS (2010). Formulation and evaluation of nanosuspensions for enhancing the dissolution of poorly soluble mebendazole. Indian Drugs 47: 47-54. • Swamy NGN, Shilpa P, Abbas Z (2012). Formulation and characterization of medicated chewing gums of dextromethorphan hydrobromide. Indian Drugs 49: 29-35. • Testa ES (1999). Medicated chewing gum and process for preparing thereof. US Patent No 5,866,179. • Tyrpin HT, Russell MP, Witkewitz DL, Johnson SS, Ream RL, Corriveau CL (2002). Caffeine coated chewing gum product and process of making. US Patent No 6444241: 1-15. • Woodford DW, Lesko LJ (1981). Relative bioavailability of aspirin gum. J Pharm Sci 70:1341-1343. https://doi.org/10.1002/jps.2600701213 PMid:7320849 • Zyck DJ, Greenberg MJ, Barkalow DG, Marske SW, Schnell PG, Mazzone P (2003). Method of making coated chewing gum products containing various antacids. US Patent No 6645535: 1-14.