Table 5.
List of biodegradable polymers approved by the US Food and Drug Administration for use in the preparation of nanodrugs updated to September 2012 (http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm)
| Polymer | Route, dosage form | CAS number |
|---|---|---|
| Acrylates copolymer | TD, controlled-release patch | – |
| Acrylic acid-isooctyl acrylate copolymer | TD, controlled-release film | – |
| Ammonio methacrylate copolymer | O, tablet | – |
| Ammonio methacrylate copolymer type A | O, extended-release capsule | 33434241 |
| Ammonio methacrylate copolymer type B | O, extended-release tablet | 33434241 |
| Butyl ester of vinyl methyl ether/maleic anhydride copolymer (125,000 molecular weight) | T, solution | 25119680 |
| Carbomer homopolymer type A (allyl pentaerythritol crosslinked) | O, extended-release tablet | 138757683 |
| Carbomer homopolymer type B (allyl sucrose crosslinked) | T, gel | – |
| Carboxy vinyl copolymer | T, gel | – |
| Cellulosic polymers | O, capsule, enteric-coated pellets | – |
| Dimethylaminoethyl methacrylate-butyl methacrylate-methyl methacrylate copolymer | O, sustained-action capsule | – |
| Dimethylsiloxane/methylvinylsiloxane copolymer | I, pellet, implant | – |
| Divinylbenzene styrene copolymer | OPH, suspension, drops | – |
| Ethyl acrylate-methacrylic acid copolymer | O, delayed-action, coated, hard gelatin capsule | – |
| Ethyl acrylate and methyl methacrylate copolymer (2:1; 750,000 molecular weight) | O, capsule, enteric-coated pellets | – |
| Ethylene vinyl acetate copolymer | I, rod | – |
| Ethylene-propylene copolymer | TD, controlled-release film | – |
| Ethylene-vinyl acetate copolymer (28% vinyl acetate) | V, insert | – |
| Glycerin polymer solution i-137 | O, tablet | – |
| Glycerin polymer solution im-137 | O, tablet | – |
| Hydrogel polymer | V, extended-release insert | – |
| Ink/polyethylene terephthalate/aluminum/polyethylene/sodium polymethacrylate/ethylene vinyl acetate copolymer | TD, controlled-release film | – |
| Isooctyl acrylate/acrylamide/vinyl acetate copolymer, Kollidon® VA 64 polymer | O, tablet, film-coated | – |
| Methacrylic acid-ethyl acrylate copolymer (1:1) type A | O, capsule | 25212888 |
| Methacrylic acid-methyl methacrylate copolymer (1:1) | O, capsule | 25086151 |
| Methacrylic acid-methyl methacrylate copolymer (1:2) | O, tablet | 25086151 |
| Methacrylic acid copolymer | O, capsule | – |
| Methacrylic acid copolymer type A | O, sustained-action, coated tablet | 25086151 |
| Methacrylic acid copolymer type B | O, extended-release capsule | 25086151 |
| Methacrylic acid copolymer type C | O, sustained-action tablet | 25212888 |
| Octadecene-1/maleic acid copolymer | T, lotion | – |
| PEG-22 methyl ether/dodecyl glycol copolymer | T, cream, augmented | – |
| PEG-45/dodecyl glycol copolymer | T, cream, augmented | – |
| Polyester polyamine copolymer | TD, controlled-release film | – |
| Poly(ethylene glycol) 1,000 | O, R, RP, and V; concentrate, solution, tablet, film-coated, suppository, aerosol, metered, emulsion, aerosol foam | 25322683 |
| Poly(ethylene glycol) 1,450 | O, T, and U; solution, suspension, extended-release tablet, film-coated, topical, ointment, suppository | 25322683 |
| Poly(ethylene glycol) 1,500 | O and T; tablet, ointment | 25322683 |
| Poly(ethylene glycol) 1,540 | D and R; gel, paste, solution, tablet, coated, ointment | 25322683 |
| Poly(ethylene glycol) 200 | IM, O, and T; injection, capsule, solution, tablet extended-release, ointment | 112607 |
| Poly(ethylene glycol) 20,000 | O, hard gelatin capsule, delayed-action, enteric-coated tablet | 25322683 |
| Poly(ethylene glycol) 200,000 | O, extended-release tablet | – |
| Poly(ethylene glycol) 2,000,000 | O, tablet | – |
| Poly(ethylene glycol) 300 | IV, IM, OPH, and T; injection, film-coated tablet | 2615158 |
| Poly(ethylene glycol) 300–1,600 | O, tablet, delayed-action, enteric-coated | – |
| Poly(ethylene glycol) 300–1,600 | T, ointment | – |
| Poly(ethylene glycol) 3,350 | IA, IL, IM, N, SC, and T; injection, solution, spray, soft gelatin capsule, extended-release tablet, ointment | 25322683 |
| Poly(ethylene glycol) 3,500 | O, suspension, sustained-action tablet, film-coated tablet | 25322683 |
| Poly(ethylene glycol) 400 | IV, N, OPH, O, R, T, and V; injection, spray metered, ointment, capsule, capsule coated soft gelatin, capsule soft gelatin liquid-filled, capsule extended-release, capsule sustained-action hard gelatin, oral syrup, controlled-release tablet, enteric-coated particles tablet, suppository, emulsion cream | 25322683 |
| Poly(ethylene glycol) 4,000 | IA, IL, IM, O, R, SL, and V; injection, capsule, capsule enteric-coated pellets, delayed-action enteric-coated tablet, extended-release tablet, sustained-action tablet, suppository, sublingual tablet, emulsion cream | 25322683 |
| Poly(ethylene glycol) 4,500 | O, tablet-coated, tablet film-coated | 25322683 |
| Poly(ethylene glycol) 540 | T, ointment | 25322683 |
| Poly(ethylene glycol) 600 | IV, O, and T; injection, soft gelatin capsule, soft gelatin liquid-filled capsule, tablet, delayed-action enteric-coated tablet, solution, sustained-action tablet | 25322683 |
| Poly(ethylene glycol) 6,000 | O, R, T, and V; capsules, extended-release capsule, hard gelatin capsule, sustained-action capsule, (immed/comp release) film-coated tablet, delayed-action tablet, delayed-action enteric-coated tablet, sustained-action coated tablet, suppository, emulsion cream, film-coated tablet | 25322683 |
| Poly(ethylene glycol) 7,000 | O, controlled-release tablet, extended-release tablet | 25322683 |
| Poly(ethylene glycol) 7,000,000 | O, tablet, extended-release | – |
| Poly(ethylene glycol) 800 | O, tablet | 25322683 |
| Poly(ethylene glycol) 8,000 | O, OPH, T, and V; solution, hard gelatin capsule, sustained-action capsule, (immed/comp release) uncoated chewable tablet, delayed-action enteric-coated tablet, orally disintegrating delayed-release tablet, sustained-action coated tablet, emulsion cream, topical powder, vaginal tablet | 25322683 |
| Poly(ethylene glycol) 900 | T, ointment, solution | 25322683 |
| Polyvinyl chloride-polyvinyl acetate copolymer | TD, controlled-release film | – |
| Povidone acrylate copolymer | T, liquid solution | – |
| Povidone/eicosene copolymer | T, lotion | 28211189 |
| Polyoxy(methyl-1,2-ethanediyl), alpha-hydro-omega-hydroxy-, polymer with 1,1′-methylenebis[4-isocyanatocyclohexane] copolymer (Ppg-12/SMDI) | T, lotion | 9042824 |
| Polyvinyl methyl ether/maleic acid copolymer (PVM/MA) | D, paste | 9011169 |
| Styrene/isoprene/styrene block copolymer | T, patch | – |
| Vinyl acetate-crotonic acid copolymer | O, sustained-action capsule | – |
Abbreviations: D, dental; I, implantation; IA, intra-articular; IL, intralesional; IM, intramuscular; IV, intravenous; N, nasal; O, oral; OPH, ophthalmic; R, rectal; RP, respiratory; SC, subcutaneous; SL, sublingual; TD, transdermal; T, topical; U, urethral; V, vaginal; MTT, 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide; ATP, adenosine triphosphate; TNF-α, tumor necrosis factor-alpha; PEG, poly(ethylene glycol); CAS, chemical abstracts service; immed/comp release, immediate release solid dosage form.