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. 2023 May 3:1–22. Online ahead of print. doi: 10.1007/s11095-023-03517-w

Table I.

FDA Approved Products Developed Using Complexation Technique

Complexing agent Dosage Form Active Ingredient Marketed product Approval Date Uses Ref
Inclusion Complexation
Cyclodextrin Oral chewable Cetirizine HCl CHILDREN'S ZYRTEC ALLERGY 2007 Taste Masking [23]
Oral Drospirenone + Ethinyl estradiol YAZ 2001 Stability of Ethinyl estradiol [24]
Topical gel Metronidazole METROGEL 1988 Solubility [25]
HPβCD Injection Telavancin VIBATIV 2009 [26]
Diclofenac sodium DYLOJECT 2014 [27]
Letermovir PREVYMIS 2017 [28]
Tecovirimat TPOXX 2018 [29]
Oral solution Larotrectinib VITRAKVI 2018 [30]
Oral solid Cladribine MAVENCLAD 2019 [31]
SBEβCD Injection Remdesivir VEKLURY® 2020 [32]
Voriconazole VFEND® 2002 [33]
Delafloxacin BAXDELA 2017 [34]
Posaconazole F Noxafil 2006 [35]
Brexanolone ZULRESSO 2019 [36]
Fosphenytoin sodium CEREBYX® 1996 stability [37]
Ion-resin Complexation
Sodium polystyrene sulfonate Extended-release chewable tablet Methylphenidate hydrochloride QuilliChew ER. 2015 Prolong dissolution [38]
Extended-release oral suspension Methylphenidate hydrochloride QUILLIVANTTM XR 2012 [39]
Extended-release oral suspension Chlorpheniramine polistirex; codeine polistirex TUZISTRA XR 2015 [40]
Extended-release oral suspension Chlorpheniramine polistirex; hydrocodone polistirex TUSSIONEX PENNKINETIC 2012
Extended-release oral suspension Dextromethorphan polistirex DELSYM 2017 [41]
Pharmacosomes
Phospholipid [1-α-dimyristoylphosphatidylcholine (DMPC) and l-α-dimyristoylphosphatidylglycerol (DMPG)] Injection Amphotericin B ABELCET 1995 Biodistribution and reduce toxicity [42, 43]
Metal Complexes
Silver Topical cream Silver sulfadiazine Silvadene 1982 Pharamcodynamics propertics [44]
Zinc Ophthalmic ointment Bacitracin zinc Lumi-sporyn  1982 stability [45]