TOXICOLOGICAL EFFECTS OF NANOPARTICLE MEDIATED DRUG DELIVERY

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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