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

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 copy

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

Authorship SCIMAGO INSTITUTIONS RANKINGS

Polymorphism in solids is a common phenomenon in drugs, which can lead to compromised quality due to changes in their physicochemical properties, particularly solubility, and, therefore, reduce bioavailability. Herein, a bibliographic survey was performed based on key issues and studies related to polymorphism in active pharmaceutical ingredient (APIs) present in medications from the Farmácia Popular Rede Própria. Polymorphism must be controlled to prevent possible ineffective therapy and/or improper dosage. Few mandatory tests for the identification and control of polymorphism in medications are currently available, which can result in serious public health concerns.

Polymorphism; Medicines/quality control; Medicines/solubility; Medicines/bioavailability

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