PHYSICOCHEMICAL AND MICROBIOLOGICAL ANALYSES OF LIDOCAINE AND PRILOCAINE THERMOSETTING GEL FOR PERIODONTAL ANESTHESIA
Keywords:
Lidocaine, Prilocaine, Thermosetting gel, Periodontal proceduresAbstract
The non-invasive anesthesia, with the application of an anesthetic gel into the periodontal pocket, appears as an alternative in the periodontal treatment. The aim of this study was to analyze and to discuss the physicochemical and microbiological properties of a lidocaine (25 mg/g) and prilocaine (25 mg/g) thermosetting gel (test-gel) for oral use. The pH, density and consistence, as well as the microorganisms’ growth evaluation were determined for the test- gel. All tests were done in triplicate, and compared with the standard-gel composed of ethylene oxide-propylene oxide block copolymers. In average, the results showed a pH of 7.71 and a density of 1.01949 g/mL for the test-gel. Also, an increase on the consistency due to changes of the test temperature was demonstrated. No microorganisms’ growth was observed. These physicochemical and microbiological data confirm the test-formulation compatibility for oral application, and ensure the efficiency and safety of this thermosetting gel for the indicated use.
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Kelly HM, Deasy PB, Ziaka E, Claffey N. Formulation and preliminary in vivo dog studies of a novel drug delivery system for the treatment of periodontitis. Int J Pharm 2004; 274: 167-173.
Pihlstrom BL, Hargreaves KM, Bouwsma OJ, Myers WR, Goodale MB, Doyle MJ. Pain after periodontal scaling and root planing. J Am Dent Assoc 1999; 130: 801-807.
Jeffcoat MK, Geurs NC, Magnusson I. Intrapocket anesthesia for scaling and root planning: results of a double blind multicenter trial using lidocaine prilocaine dental gel. J Periodontol 2001; 72: 895-900.
Perry DA, Gansky SA, Loomer PM. Effectiveness of a transmucosal lidocaine delivery system for local anaesthesia during scaling and root planning. J Clin Periodontol 2005; 32: 590-594.
Friskopp J, Nilsson M, Isacsson G. The anesthetic onset and duration of a new lidocaine/prilocaine gel intra-pocket anesthetic (Oraqix) for periodontal scaling/root planning. J Clin Periodontol 2001; 28: 453-458.
Donaldson D., Gelskey SC, Landry RG, Matthews DC, Sandhu HS. A placebo- controlled multi-centred evaluation of an anaesthetic gel (Oraqix®) for periodontal therapy. J Clin Periodontol 2003; 30: 171-175.
Magnusson I, Jeffcoat MK, Donaldson D, Otterbom IL, Henriksson J. Quantification and analysis of pain in nonsurgical scaling and/or root planing. J Am Dent Assoc 2004; 135: 1747-1754.
Shin SC, Cho CW, Yang KH. Development of lidocaine gels for enhanced local anesthetic action. Int J Pharm 2004; 287: 73-78.
Malamed SF. Manual de anestesia local. Rio de Janeiro: Elsevier Ed., 2005.
Araújo LMT, Amaral JLG. Allergy to lidocaine: case report. Rev Bras Anestesiol 2004; 54: 672-676.
Pipa Vallejo A, Garcia-Pola Vallejo MJ. Local anesthetics in dentistry. Med Oral patol Oral Cir Bucal 2004; 9: 438-443.
Regatieri FLF. Intoxicação por anestésicos locais. disponível em: . acesso em: 22 ago. 2005.
Roberts DH, Sowray JH. Analgesia local em Odontologia. São Paulo: Livraria Santos Ed., 1995.
Vasconcellos RJH, Nogueira RVB, Leal AKR, Oliveira CTV, Bezerra JGB. Alterações sistêmicas decorrentes do uso da lidocaína e prilocaína na prática odontológica. Rev Cir Traumat Buço-Maxilo-Facial 2002; 1: 13-19.
Devers A, Galer BS. Topical lidocaine patch relieves a variety of neuropathic pain conditions: an open-label study. Clin J Pain 2000; 16: 205-208.
Meechan JG, Thomason JM. A comparison of 2 topical anesthetics on the discomfort of intraligamentary injections: a double-blind, split-mouth volunteer clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1999; 87: 362-365.
van Steenberghe D, Bercy P, De Boever J et al. Patient evaluation of a novel non-injectable anesthetic gel : a multicenter crossover study comparing the gel to infiltration anesthesia during scaling and root planing. J Periodontol 2004; 75: 1471-1478.
Kumar MNVR. Nano and microparticles as controlled drug delivery devices. J Pharm Pharmaceut Sci 2000; 3: 234-258.
Aulton ME. Delineamento de formas farmacêuticas. Porto Alegre: Artmed, 2005.
Pelczar Jr. MJ, Chan ECS, Krieg NR. Microbiologia: conceitos e aplicações. 2 ed. Rio de Janeiro: Makron Books, 1996, vol. II.
Thompson JE. A practical guide to contemporary pharmacy practice. Baltimore: Williams & Wilkins, 1998.
Brasil. Ministério da Saúde. Agência Nacional de Vigilância Sanitária. Resolução da Diretoria Colegiada no. 33. Brasília: Anvisa, 2000.
Schmolka IR. BWC surfactants in gel cosmetics. Cosmetics Toiletries 1977; 92: 77-79.
Fonseca SC, Ferreira AO. Novidades magistrais: compêndio de atualização em matérias-primas. São Paulo: [sn], 2004.
Ferreira AO. Guia prático da farmácia magistral. 2 ed. Juiz de Fora: [sn], 2002.
Comissão Permanente de Revisão da Farmacopéia Brasileira. Farmacopéia Brasileira. 4 ed. São Paulo: Atheneu, 2000.
Panzeri H, Lara EHG, Siéssere F, Marchetti RM. Avaliação de dentifrícios: primeira parte - consistência, densidade, pH, vida útil e perda de água. Odont Mod 1978; 4: 4-10.
Prista LN, Alves AA. Tecnologia farmacêutica e farmácia galênica. Lisboa: Fundação Calouste Gulbenkian, 1967.
Pinto TJA, Kaneko TM, Ohara MT. Controle biológico de qualidade de produtos farmacêuticos, correlatos e cosméticos. São Paulo: Atheneu, 2000.
Scherlund M, Malmsten M, Holmqvist P, Brodin A. Thermosetting microemulsions and mixed micellar solutions as drug delivery systems for periodontal anesthesia. Int J Pharm 2000; 194: 103-116.
Esposito E, Carotta V, Scabbia A et al. Comparative analysis of tetracycline- containing dental gels: Poloxamer- and monoglyceride-based formulations. Int J Pharm 1996; 142: 9-23.
Andrade FRO, Souza AA, Arantes MCB, De Paula JR, Bara MTF. Análise microbiológica de matérias-primas e formulações farmacêuticas magistrais. Rev Eletr Farm 2005; 2: 38-44.
Guedes LC. Controle de qualidade na indústria farmacêutica. Rio de Janeiro: Manuais CNI, 1987.
Appel G, Reus M. Formulações aplicadas à Odontologia. São Paulo: RCN Ed., 2003.
Alexandridis P, Hatton TA. Poly(ethylene oxide)-poly(propylene oxide)- poly(ethylene oxide) block-copolymer’surfactants in aqueous solutions and interfaces - thermodynamics, structure, dynamics and modeling. Colloids Surf. 1995; 96: 1-46.
Goddard ED, Ananthapadmanabhan KP. Interaction of surfactants with polymers and proteins. Boca Raton: CRC Press, 1993.
Malmsten M, Lindman B. Self-assembly in aqueous: copolymer solutions. Macromolecules 1992; 25: 5440-5445.
Gilbert JC, Washington C, Davies MC, Hadgraft J. The behaviour of Pluronic F127 in aqueous solution studied using fluorescent probes. Int J Pharm 1987; 40: 93-99.
Scherlund M, Malmsten M, Brodin A. Stabilization of a thermosetting emulsion system using ionic and nonionic surfactants. Int J Pharm 1998; 173: 103-116.
Miyazaki S, Takeuchi S, Yokouchi C, Takada M. Gels as a vehicle for topical administration of anticancer agents. Chem Pharm Bull 1984; 32: 4205-4208.
Brasil. Ministério da Saúde. Agência Nacional de Vigilância Sanitária. Resolução nº. 481: Controle de qualidade microbiológico para os produtos de higiene pessoal, cosméticos e perfumes. Brasília: Anvisa, 1999.
