Santos, Olímpia Maria Martins; Reis, Maria Esther Dias; Jacon, Jennifer Tavares; Lino, Mônica Esselin de Sousa; Simões, Juliana Savioli; Doriguetto, Antonio Carlos

doi:10.1590/S1984-82502011000100002

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Brazilian Journal of Pharmaceutical Sciences

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Reviews • Braz. J. Pharm. Sci. 50 (1) • Jan-Mar 2014 • https://doi.org/10.1590/S1984-82502011000100002 copiar

Polymorphism: an evaluation of the potential risk to the quality of drug products from the Farmácia Popular Rede Própria

Autoria SCIMAGO INSTITUTIONS RANKINGS

O polimorfismo em sólidos é um fenômeno frequente em fármacos e pode levar a problemas na qualidade dos medicamentos por alterar suas propriedades físico-químicas, em especial a solubilidade e, consequentemente, a biodisponibilidade. Nesse trabalho realizou-se levantamento bibliográfico sobre os principais estudos e problemas relacionados ao polimorfismo em fármacos presentes nos medicamentos disponibilizados pela Farmácia Popular do Brasil. O polimorfismo deve ser controlado a fim de evitar possível ineficácia terapêutica e/ou dosagem inapropriada dos medicamentos. Destacamos que são poucos os ensaios obrigatórios para identificação e controle desse fenômeno em medicamentos, o que pode acarretar grande problema de saúde pública.

Polimorfismo; Medicamentos/controle de qualidade; Medicamentos/solubilidade; Medicamentos/biodisponibilidade

API	Indication	BCS	#	Stable form*	Reference
Acyclovir	Antiviral	III	6	I	(TSRL inc, 2012; Kristl et al., 1996; Sohn et al., 2008; Lutker et al., 2011; Tutughamiarso et al, 2012)

Acetylsalicylic Acid	Analgesic	IV	2	I	(TSRL inc, 2012; Klein et al., 1994; Vishweshwar et al., 2005; Bond et al., 2011)

Ibuprofen	Analgesic	II	2	I	(TSRL inc, 2012; Shankland et al., 1996; Erk et al., 2004; Stone et al., 2009; Derollez et al., 2010)

Acetaminophen	Analgesic	IV	6	I	(TSRL inc, 2012; Haisa et al., 1974; Naumov et al., 1998; McGregor et al., 2002; Parkin et al., 2002; Peterson et al., 2002; Fabbiani et al., 2004)

Albendazole	Anthelmintic	II	2	II	(TSRL inc, 2012; Pranzo et al., 2010)

Mebendazole	Anthelmintic	II	3	A	(TSRL inc, 2012; Rodriguez-Caabeiro et al., 1987; Martins et al., 2009; Ferreira et al., 2010)

Loratadine	Antiallergic	II	2	‡	(TSRL inc, 2012; Khunt, 2008; Gala, 1999)

Ferrous sulfate	Antianemic	†	3	‡	(Wehner et al., 1976)

Folic acid	Antianemic	IV	1	Dihydrate	(TSRL inc, 2012; Mastropaolo et al.,1980)

Diazepam	Antianxiety	II	2	‡	(TSRL inc, 2012; Camerman et al.,1972)

Amiodarone hydrochloride	Antiarrhythmic	II	1	‡	(Wu et al., 2005; Cody et al., 1989)

Digoxin	Antiarrhythmic	I	3	Amorphous	(TSRL inc, 2012; Chiou et al., 1979; Go et al., 1980; Eberhard et al., 1983)

Verapamil hydrochloride	Antiarrhythmic, Antihypertensive	II	1	‡	(TSRL inc, 2012; Carpy et al., 1985; Yoshida et al., 2010)

Amoxicillin	Antibiotic	IV	1	Trihydrate	(TSRL inc, 2012; Boles et al., 1978)

Azithromycin	Antibiotic	II or IV	3	Dihydrate	(TSRL inc, 2012; Blanco M et al., 2005; Montejo-Bernardo et al., 2009)

Benzylpenicillin	Antibiotic	I or III	1	I	(TSRL inc, 2012; Dexter et al., 1978)

Cephalexin (hydrochloride or sodium salt)	Antibiotic	II	8	IV (monohydrate)	(Otsuka et al., 1983; Stephenson et al., 1998; Kennedy et al., 2003; Kasim et al., 2004; Aguiar et al., 2011)

Ciprofloxacin	Antibiotic	III	3	II (hydrate)	(TSRL inc, 2012; Turel et al., 2003; Fabbiani et al., 2008; Fabbiani et al., 2009; Fabbiani et al., 2011)

Doxycycline	Antibiotic	IV	2	‡	(TSRL inc, 2012; Legendre et al., 2012)

Erythromycin	Antibiotic	IV	4	Dihydrate	(TSRL inc, 2012; Fukumori et al., 1983; Stephenson et al., 1997; Miroshnyk et al., 2006)

Sulfamethoxazole	Antibiotic	IV	4	III (hemihydrate)	(TSRL inc, 2012; Maury et al., 1985; Hartauer et al., 1992; Takasuka et al.,2001; Price et al., 2005; Fioritto et al., 2007)

Sulfasalazine	Antibiotic	II	2	‡	(TSRL inc, 2012; Bilton et al., 1999; Filip et al., 2001)

Trimethoprim	Antibiotic	IV	1	‡	(TSRL inc, 2012; Koetzle et al., 1976)

Carbamazepine	Anticonvulsant	II	6	Dihydrate	(TSRL inc, 2012; Himes et al., 1981; Rebou et al., 1981; Lowes et al., 1987; Lisgarten et al., 1989; Lang et al., 2002; Grzesiak et al., 2003; Harris et al., 2005; Gelbrich et al., 2006; Kogan et al., 2008; Arlin et al., 2011)

Phenytoin	Anticonvulsant	II	1	I	(TSRL inc, 2012; Nokhodchi et al., 2003)

Phenobarbital	Anticonvulsant	IV	13	A	(TSRL inc, 2012; Otsuka et al., 1993; Platteau et al., 2005; Zencirci et al., 2009; Zencirci et al., 2010)

Amitriptyline hydrochloride	Antidepressant	I	1	I	(TSRL inc, 2012; Klein et al., 1994)

Fluoxetine hydrochloride	Antidepressant	I	1	I	(TSRL inc, 2012; Robertson et al., 1988)

Glibenclamide	Antidiabetic	II	1	I	(TSRL inc, 2012; Byrn et al., 1986)

Metformin hydrochloride	Antidiabetic	III	2	A	(TSRL inc, 2012; Childs et al., 2004)

Metoclopramide hydrochloride	Antiemetic	II or IV	3	‡	(TSRL inc, 2012; Pabón et al., 1996)

Clonazepam	Antiepileptic	†	1	I	(Chananont et al., 1979)

Ketoconazole	Antifungal	II	2	I (enantiomer +)	(Peeters et al., 1979; Peeters et al., 2004; Wu et al., 2005)

Fluconazole	Antifungal	III	4	I	(TSRL inc, 2012; Alkhamis et al., 2002; Caira et al., 2004; Chandavarkar, Jindai, Kulkarni, 2011)

Miconazole Nitrate	Antifungal	†	3	‡	(Pedersen et al., 1993; Peeters et al., 2004)

Promethazine hydrochloride	Antihistamine	I	2	‡	(TSRL inc, 2012; Borodi et al., 2012)

Atenolol	Antihypertensive	III	2	I	(TSRL inc, 2012; Esteves De Castro et al., 2007)

Captopril	Antihypertensive	III	2	I (B)	(TSRL inc, 2012; Haoming et al., 1985; Fekete, 1997; Zhenhong et al., 2011)

Enalapril maleate	Antihypertensive	I	2	II	(TSRL inc, 2012; Précigoux et al., 1986; Evjolfsson, 2003; Kiang et al., 2003)

Losartan	Antihypertensive	III	5	I	(TSRL inc, 2012; Campbell et al., 1997; Dolitzky et al., 2004; Wu et al., 1993; Fernández et al., 2002; Tessler et al., 2004)

Methyldopa	Antihypertensive	III	1	‡	(TSRL inc, 2012; Neuman et al., 1984)

Nifedipine	Antihypertensive	II	3	A= I= α	(TSRL inc, 2012; Uekama et al., 1992; Grooff et al., 1997; Gunn et al., 2012)

Propranolol hydrochloride	Antihypertensive	I	3	II	(TSRL inc, 2012; Bartolomei et al., 1999; Bredikhin et al., 2004)

Simvastatin	Antilipemic	II	3	I	(TSRL inc, 2012; Cejka et al., 2003; Husak et al., 2010)

Biperiden	Antiparkinsonian	I	1	I	(TSRL inc, 2012; Codding, 1986)

Carbidopa	Antiparkinsonian	I	‡	‡	(Lindenberg et al., 2004)

Levodopa	Antiparkinsonian	I	2	I	(TSRL inc, 2012; Mostad et al., 1970; Mostad et al., 1971; Howard et al., 1995)

Benserazide hydrochloride	Antiparkinsonian	†	‡	‡	‡

Metronidazole	Antiprotozoal	IV	1	‡	(TSRL inc, 2012; Galván-Tejada et al., 2002)

Chlorpromazine	Antipsychotic	II	2	Anhydrous	(TSRL inc, 2012; McDowel, 1969; Klein et al., 1986)

Haloperidol	Antipsychotic	II	1	I	(TSRL inc, 2012; Prasanna et al., 2001)

Omeprazole	Antiulcer	†	1	‡	(Ohishi et al., 1989)

Ranitidine hydrochloride	Antiulcer	III	4	II	(TSRL inc, 2012; Ngooi et al., 1994, Agatonovic-Kustrin et al., 1999; Hempel et al., 2000; Chieng et al., 2006)

Oseltamivir phosphate	Antiviral	I or III	1	‡	(TSRL inc, 2012; Kang et al., 2012)

Salbutamol sulfate	Bronchodilator	I	3	I	(Lindenberg et al., 2004; Lulla et al., 2011, Rao et al., 2011; Palacio et al., 2007)

Allopurinol	Chronic gout treatment	IV	1	I	(TSRL inc, 2012; Prusiner et al., 1972)

Ethinyl estradiol	Contraceptive	I	1	Hemihydrate	(TSRL inc, 2012; Guguta et al., 2008)

Levonorgestrel	Contraceptive	I	2	‡	(TSRL inc, 2012; Chang, Chen, 2009)

Norethisterone	Contraceptive	I	1	‡	(Lindenberg et al., 2004; Reisch et al., 1993; Shikii et al., 2005)

Furosemide	Diuretic	IV	3	I	(TSRL inc, 2012; Babu et al., 2010)

Hydrochlorothiazide	Diuretic	IV	2	‡	(TSRL inc, 2012; Leech et al., 2008)

Prednisone	Glucocorticoid	I	1	‡	(Vogt et al., 2007; Suitchmezian et al., 2008)

Azathioprine	Immunosuppressant	IV	2	‡	(TSRL inc, 2012; Cook, Bugg, 1975; Acharya,1984)

Alendronate sodium	Inhibitor of bone resorption	III	13	‡	(TSRL inc, 2012; Kieczykowski et al.,1990; Vega et al., 1996; Finkelstein et al., 2004; Asnani et al., 2009)

Isosorbide mononitrate	Vasodilator	I	2	‡	(Fotaki, Vertzoni, 2010; Kanters et al., 1993)

Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Av. Prof. Lineu Prestes, n. 580, 05508-000 S. Paulo/SP Brasil, Tel.: (55 11) 3091-3824 - São Paulo - SP - Brazil
E-mail: bjps@usp.br

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[1] *Correspondence: A. C. Doriguetto. Instituto de Química, Universidade Federal de Alfenas. Rua Gabriel Monteiro da Silva, 700 – Centro – 37130-000 – Alfenas - MG, Brasil. E-mail: doriguetto@unifal-mg.edu.br