Toxicological Effects Of Nanoparticle Mediated Drug Delivery
Safety and toxicological issues are the most important issues for a drug delivery system. Safety is an obvious concern for the fast growth of nanoparticles mediated drug delivery. Different nanoparticle based delivery systems are being developed for pharmaceutical ingredients deliveries should be examined properly from the point of toxicity. Therefore, study design related to toxicity testing is required. It has been noted that the use of nanoparticles as drug transporter may decrease the toxicity of the incorporated drug. However, toxicity of the “vacant” non-drug loaded particles should be evaluated properly (217).
Some studies of nanoparticle mediated drug delivery related to toxicological effects in vitro model have been performed (218). Conversely, it is found that the decrease in size due to the nanocarrier can cause variation in the physicochemical and structural properties of produced nanoparticles that can be accountable for numerous material interactions that may produce toxic effects (219). However, there is a huge gap among research exploration on toxicology and nanoscaled pharmaceutical ingredient delivery (220) and proper extensive research should be initiated to fill the gap.
Table 2. Nanoparticle-mediated drugs which are in clinical trial
| Sl.No | Product and company name | Nanoparticle based delivery system and Pharmaceutical ingredient | Clinical trial status | Indication | Delivery route | Reference |
| 1 | L-Annamycin(Callisto Pharma, USA) | Delivery system: LiposomeIngredient: annamycin | Phase II | Acute lymphocytic leukemia,acute myeloid | Injection (Intravenous route) | 239 |
| 2 | SLIT Cisplatin(Transave, Inc, USA) | Delivery system: LiposomeIngredient: cisplatin | Phase I | Progressive osteogenicsarcoma metastatic tothe lung | Pulmonary delivery | 240 |
| 3 | SP1049C(Supratek Pharma, Canada) | Delivery system: Pluronic block-copolymerIngredient: doxorubicin | Phase II | Esophageal carcinoma | Injection (Intravenous route) | 241 |
| 4 | CT-2106(Cell Therapeutics, Inc.,USA) | Delivery system: Polyglutamate-nanoparticleIngredient: camptothecin | Phase II | Colorectal and ovariancancers | Injection (Intravenous route) | 242 |
| 5 | Transdrug(BioAlliance Pharma, Paris) | Delivery system: Poly(iso-hexyl-cyanoacrylate)Ingredient: doxorubicin | Phase II | Hepatocellular carcinoma | Injection (Intra-arteria route) | 243 |
| 6 | BioVant(BioSante Pharma,USA) | Delivery system: Calcium phosphate nanoparticleIngredient: vaccine adjuvant | Phase I | Vaccine adjuvant | Injection (subcutaneous route) | 244 |
| 7 | NB-001(NanoBio, USA) | Delivery system: NanoemulsionIngredient: NB-001 | Phase II | Herpes labialis | Topical | 245 |
| 8 | AI-850(Acusphere Inc.USA) | Delivery system: nanoparticles in porous, hydrophilic matrixIngredient: Paclitaxel | Phase I | Solid tumors | Injection (Intravenous route) | 246,247 |
| 9 | Basulin(Flamel Technologies, France) | Delivery system: L-Leucine, L-glutamate copolymer,Ingredient: insulin | Phase II | Type I diabetes | Injection (subcutaneous route) | 248 |
| 10 | VivaGel(Starpharma,UK) | Delivery system: Poly-L-lysine dendrimerIngredient: SPL7013 | Phase II | Antimicrobial protectionfrom genital herpesand HIV infection | Topical | 249 |
| 11 | Panzem NCD(Elan, USA ) | Delivery system: Nano-crystalIngredient: 2-methoxyestradiol | Phase II | Several type cancers | Oral | 250 |
| 12 | ProLindac(AccessPharma, USA) | Delivery system: HPMA copolymerIngredient: DACH platinate | Phase II | Ovarian cancers | Injection (Intravenous route) | 251 |
| 13 | CYT-6091 (Aurimmune) (CytoImmune Science, USA) | Delivery system: PEGylated colloidal gold nanoprticle Ingredient: TNF alpha | Phase II | Solid tumar | Injection (Intravenous route) | 252 |
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