Targeted Drug Delivery through Nanosponges and its Approach

 

Praveen. K¹*, Balamurugan. K²

¹M.Pharm., IInd Year, Department of Pharmacy, FEAT, Annamalai University, Annamali Nagar,

Chidambaram - 608002, Tamilnadu, India.

²Associate Professor, Department of Pharmacy, FEAT, Annamalai University, Annamali Nagar,

Chidambaram - 608 002, Tamilnadu, India.

 

ABSTRACT:

Efficient targeted drug transport approaches have been a dream for several decades. Nanosponge’s drug transport system has emerged as one of the promising discipline in novel drug delivery technology. Recently the nanosponge drug delivery system has been big step to resolve the certain biopharmaceutical problems. The nanosponge targets the drug into the systemic circulation in the body until they encounter the particular targeted surface, and begin the release of drug in controlled drug and predictable way. Nanosponge’s drug release systems were loaded with hydrophilic and lipophilic drug substance in a huge range drug molecule. Thus the nanosponge acts as suitable targeted carrier molecule. In the nanosponge technique the drug can be deliver in specific site, which prevent the drug, protein degradation, prolong drug release is a predictable way. Nanosponge technology is used to increasing the poor bioavailability of drug substance and the transport of drug into oral, parenteral as well as topical route. In the review article, the approaches for the preparation, evaluation and application of nanosponge were discussed.

 

 

 

INTRODUCTION:

Targeting the drug delivery system has been big troubleshooting for scientific research. How to target the drug in proper site of circulation inside the body and how to manipulate the quantity of drug to prevent the dose dumping in the body^[1]. The evolution of latest technology called nanosponge were the possible to remedy these problems.

 

Nanosponges are a nano sized particle with porous of few nanometres. In the size of the tiny sponge is an endemic (250nm-1µm) with a mean diameter is less than 1µm. In those pore can be filled with type of drug substance^[2]. The sponge acts as a three dimensional integrated network or scaffold, which consists of backbone referred to as long-length polyester.

 

It is complex and mixed solution with cross-linking of the polymer^[3,4], in which the nanoparticles loaded with hydrophobic and hydrophilic nature of drug substance and it may be increase the bioavailability and stability of poorly aqueous soluble drug substance or molecules^[5]. These nanosponges can be penetrate into the systemic flow circulation across the frame until they encounter the precise target site and stick at the surface and begin the release of drug^[6,7].

 

Nanosponges are solid in nature and can be formulated in different form they're oral, parenteral, topical and inhalation dosage form. For parenteral route of administration nanosponges combined with saline, sterile water and different aqueous solution, oral route dispersed in matrix of diluents, lubricant, excipients which is convenient for the preparation of capsules and tablet^[8]. For topical targeted route successfully formulated as hydrogel nanosponges^[9,10].

 

Merits of nanosponges^[11,12]:

·       Easy scale-up for industrial manufacturing.

·       Enhance the aqueous solubility of poorly water soluble drug.

·       It improves patient compliance by sustaining drug action.

·       Nanosponges improve the stability, elegance and formulation flexibility.

·       Nanosponges’ are stable up to the temperature of 130 °C.

·       Nanosponges’ targeted drug delivery systems are devoid irritating, mutagenic, allergenic and toxic.

·       Targeted and unique route of drug transport into the body.

·       The doses of the drug in the nanosponges are less which minimize side effect.

·       The pH of the nanosponges can be vary from 1-11 and can be compatible in all condition.

 

Demerits of nanosponges:

·       In rare cases the chances of dose dumping may occur.

·       Nanosponges can be both crystalline and para-crystalline shape. The loading capability of para- crystalline structure is different. When in comparison to the crystalline structure of nanosponges.

·       Nanosponges’ formulations are suitable for small molecules and not large molecular size.

·       The drug loading efficacy of crystalline structure of nanosponges is more than the para crystalline structure.

 

Material used for nanosponge preparation:

The following polymer and cross-linking agents are used in the formulation of nanosponges are enlisted below table-1^[13][14].

 

Polymer	Cross-linkers
Hyper cross linked polystyrene, cyclodextrine and its derivatives such as alkyl oxy carbonyl cyclodextrine, hydroxyl propyl β-cyclodextrine, methyl β-cyclodextrine and co-polymer like acrylic polymer, ethyl cellulose, eudragit RS100, poly valerolactone and poly vinyl alcohol.	Carbonyl di imidazole, carboxylic acid di anhydrides, di chloromethane, di aryl carbonate, di isocyanates, di phenyl carbonate, epichloride, gluteraldehyde, pyromellitic anhydrides 2,2 bis(acrylamido) acetic acid.

 

Methods of preparation of nanosponges:

1.     Solvent method^[10][15]:

Polymers were dissolved with an appropriate solvent. In particular polar solvent such as dimethylformamide (DMF) and dimethylsulfoxide (DMS) then the addition of combination to extra quantity of cross- linkers, preferably the polymer/cross linkers molar ratio is 4-16. The reaction is accomplished at 10°C temperature of solvent for 1-48 hours. Preferred cross-linkers are carbonyl compounds such as diphenyl carbonate (DPC), dimethylcarbonate (DMC), carbonyl di imidazole (CD) ^[10,17]. Once the product is obtained by addition of cooled double distilled water. Product is filter out underneath vacuum condition and the product is purified by soxhlet extraction by ethanol. Finally the nanosponges products were obtained were dried under vacuum and homogenized into powder form^[13].

 

2.     Emulsion solvent diffusion method^[16]:

In the emulsion solvent diffusion technique nanosponges were prepare by different proportion of ethyl cellulose (EC), polyvinyl alcohol (PVA). The active pharmaceutical ingredient (API) and ethyl cellulose were dispersed and dissolve in 20ml of dichloromethane (DCM). Further, slowly added the small quantity of poly vinyl alcohol (PVA) in 150ml of aqueous continuous phase and the mixers were subjected to stirring 1000rpm for 2 hrs. The formed nanosponges were filtered and dried under the oven at 40°C for 24 hrs, to remove residual solvents and stored at air tight container.

 

Ethyl cellulose and API were dissolved in 20ml dichloromethane (DCM)

 

 

Add small amount of poly vinyl alcohol (PVA) in aqueous phase

 

 

Reaction mixture carried out at 1000 rpm for 2hrs

 

 

By using filtration nanosponge were collected

 

 

Dried in oven at 40°C for 24 hrs

 

 

Finally stored in the vacuum desiccators ensure to remove the residual solvent

 

3.     Ultrasonication technique^[17]:

In the preparation of nanosponges by ultrasonication technique the polymers were treated with cross linkers with absence of solvent and under the sonication. In the acquired nanosponges is uniform round size and less than 5 micron. In this process anhydrous β-cyclodextrine and diphenyl carbonate are blended in 250ml flask. The flasks are kept in the ultrasound bath loaded up with water and heated for 90°C with through sonication for 5 hrs. At that point a solid mass were grinded in the mortar and soxhlet extraction with ethanol for removal of the unreacted polymers and it co-substance to expel the unreacted polymer and contaminations. After the purification technique the Nanosponges were stored in air tight container at 25°C.

 

4.     Quasi emulsion solvent diffusion method^[18][19]:

In quasi emulsion solvent diffusion method can likewise be readied nanosponges utilizing the diverse amount of polymer. Eudragit RS100 blended with the reasonable dissolvable to make the internal stage. Further the medication was included into the arrangement and disintegrated by utilizing ultrasonication at 35°C. The inward stage was filled the (external stage) poly vinyl alcohol arrangement in water. Consistently mixing for an hour, at that point the blend is sifted to isolate the nanosponges. The acquired nanosponges are dried in an air-warmed stove at 40°C for 12 hours.

 

Loading of drug into the nanosponges^{[10], [13], [15], [17]}:

Nanosponge drug delivery product can be pre-treated to keep up the normal molecule size underneath 500nm. In the nanosponges were suspended in water and to avoid the presence of accumulation by sonication and centrifuged in order to get a fine suspension in the colloidal portion. To isolate, the supernatant and dried the sample by freeze drying. To formulate the nanosponge’s suspension and disperse the large amount of drug into the suspension and to maintain the suspension under constant stirring for specific time required for complexation. After, the complex is formed to remove the uncomplexed (undissolved) drug from the complex one by centrifugation. Further, the solid crystals of nanosponges were obtained by solvent evaporation or by lyophilization technique.

 

In this nanosponges crystal structure play critical role for complexation. The drug loading capacity of para crystalline structure of nanosponges is dissimilar. At the point when contrasted with the crystal structure of nanosponges. In the medication loading limit of crystal structure is greater than the para crystalline structure. In the inadequately crystalline nanosponges medication loaded happen in complex mixture rather than inclusion complex.

 

Types of drugs^[20]:

The ideal property of a drug molecule that can be formulated as nanosponges are listed below:

·       In aqueous solubility of drug should be less than 10mg/ml.

·       Melting points of the drug substance have to be much less than 250°C.

·       Structure of drug molecules should be less than 5 condensed rings.

·       The molecular weights of drug substance need to be in among the 100 to 400 Daltons.

 

Evaluation of nanosponges:

1.     Particle size determination^[21]:

Nanosponge’s particle size may be very essential for the optimization method. The particle size determination can be by dynamic light scattering technology. Particle size large than 30m can show gritty felling and particle size range from 10-25m can be preferred for topical drug transport system.

 

2.     Microscopy study^[22]:

To observe the morphology and surface topography of the drug, nanosponges and the product (drug/ nanosponges complex) can be determined by means of Scanning Electron Microscope (SEM) and Transmission Electron Microscope (TEM). The difference in crystalline state of raw materials and the products can be seen through the electron microscope.

 

3.     Zeta potential^[23]:

Zeta capacity is used to measure the surface charge. It may be measured with the aid of the additional electrode inside the particle size equipments. The surface charge of the nanosponges can be decided through zeta sizer.

 

4.     Porosity:

Porosity study is used to carry out the extent to check the nanocavites and nanochannels in the formed nanosponges. Helium pycnometer used to measure the porosity of nanosponges. Since Helium fuel is capable of penetrates inter and intra specific channel material the Helium gasoline displacement method is used to determine the genuine extent of material. Higher porosity of nanosponges can be compared to determine polymer used to fabricate system. Percentage of porosity may be determined by the following equation.

 

                            bulk volume – true volume

% of porosity = ----------------------------------------- × 100

                                       bulk volume

 

5.     Loading efficiency^[6]:

Nanosponges loading efficiency can be decided by way of quantitative estimation of drug loaded into nanosponge’s high performance liquid chromatography (HPLC)/UV spectrophotometer technique. The nanosponge % of loading performance may be determined by equation given underneath.

 

% of Loading performance = actual drug content/ theoretical drug content material × 100

 

6.     Compatibility study^{[13], [24],[25]}:

The drug substance will be mixed with the suitable polymer that are used to formation of nanosponges. The compatibility study of drug and polymer can be decided by using various techniques including Thin Layer Chromatography (TLC) and Fourier Transform and Infra-crimson Spectroscopy (FT- IR). And crystalline characteristics of powder drugs can be decided with the aid of X-ray diffraction (XRD) and Differential Scanning Colorimetry (DSC) methods.

 

7.     Solubility study^[26]:

The most extensively used method to study the inclusion complexation is the phase solubility approach. In this technique drug substance will be introduced into the Erlenmeyer flask containing an aqueous solution of diverse percentage of nanosponge’s drug. The Erlenmeyer flask turned into stirred by means of mechanical shaker at room temperature. When the study state is reached, the suspension became filtered by using centrifugation containing 3000 Daltons molecular filter (Millipore Corporation, MICRON YN 30) the product solution received became analyzed to decide by way of High Performance Liquid Chromatography (HPLC).

 

8.     Production yield ^[25]:

The production yield can be determined by calculating initial weight of raw material and final weight of nanosponges.

 

                                       Practical mass of nanosponges

Production yield = --------------------------------------------- × 100

                                                Theoretical mass

 

9.     Thermo analytical methods^[22],[27]:

In this method, the drug substance has been adjustments earlier than the thermal degradation of nanosponges. The drug substance changes by evaporation, melting, oxidation, decomposition or polymorphic transition. The nanosponges of drug substance can be changes to suggest the complex formation. Thermogram value gets from Differential Scanning Calorimetry (DSC) and Differential Thermal Analysis (DTA) can be discovered in broad vision by the shifting and appearance of new peaks / disappearance of certain peaks. Weight changes can offer helping evidence for inclusion complex formation.

 

10. Thin layer chromatography^[22]:

In thin layer chromatography, the R_f value of drug molecule is decline to sizeable volume and its allows in figuring out the complex formation among the drug and nanosponges. Inclusion complexation between the drug and polymer is a reversible system. In the R_f value may be determined by using equation given below

 

R_f value= distance travelled by using solute/ distance travelled by means of solvent.

 

11. Infra- red spectroscopy^[14]:

Infra-red spectroscopy (IR) is used to evaluate the interaction between the nanosponges and drug molecules in solid state. Nanosponges primarily based often alternate handiest barely upon complicated formation. If the fraction of drug molecule is encapsulated in the complex is much less than 25%. Bands which will be assigned to the include part of polymer the dimension have been made at constant at 90˚ for all pattern. The sample was diluted with Milli Q water for each size. Generally this technique isn't always suitable to discover the inclusion complex and less clarifying than other methods. In the software of IR spectroscopy is restrained drug having some feature is bands, which include sulfonyl or carbonyl organization.

 

12. In- vitro drug release study^[16]:

The drug release from the optimized nanosponges can be studied the usage of multi-compartment rotating cellular with artificial dialysis membrane using Franz Diffusion Cell with diffusion place 2.26cm². The donor segment consists of drug-loaded nanosponge complex in distilled water. The receptor phase additionally incorporates the equal medium. The receptor segment is withdrawn completely after fixed the time interval is diluted with appropriate distilled water and that they analysed via UV spectroscopy

 

Table 2: Example for nanosponges based on the literature survey:

S. No	Drug	Polymer/cross linkers	Technology Adopted
1.	Acyclovir	β-cyclodextrine, CDI	Ultrasound-assisted synthesis
2.	Artesunate	Ethyl cellulose, poly vinyl alcohol (PVA)	Solvent evaporation method
3.	Atorvastatine	β-cyclodextrine	Solvent evaporation method
4.	Aspirin	β-cyclodextrine, PMDA	Ultrasound-assisted synthesis
5.	Babchi oil	β-cyclodextrine, DPC	Ultrasound-assisted synthesis
6.	Bovine serum solution (protein)	β-cyclodextrine	Encapsulation technique (for protein)
7.	Calcium delivery	β-cyclodextrine, CDI	Polymer condensation method
8.	Camptothecin	β-cyclodextrine, DPC	Solvent method
9.	Cephalexin	Hydroxyl ethyl cellulose, PVA	Emulsion solvent method
10.	Cefadroxile	β-cyclodextrine, DPC	Ultrasound-assisted synthesis
11.	Celecoxib	β-cyclodextrine,N-Methylene bisacrylamide	Solvent evaporation method
12.	Ciprofloxacin-n	Ethyl cellulose, poly vinyl alcohol (PVA)	Solvent evaporation method
13.	Cilostazol	β-cyclodextrine, DPC	Ultrasound-assisted synthesis
14.	Curcumin	β-cyclodextrine, DPC	Solvent method
15.	Dexamethasone	β-cyclodextrine	Ultrasound-assisted synthesis
16.	Dextrine	β-cyclodextrine, HMDI	Interfacial polymerization method
17.	Econazole nitrate	Ethyl cellulose, poly vinyl alcohol (PVA)	Emulsion solvent method
18.	Erlotinib	β-cyclodextrine, PMDA	Condensation polymerization method
19.	Fluconazole	Ethyl cellulose, poly vinyl alcohol (PVA)	Emulsion solvent diffusion method
20.	Flurbiprofen	β-cyclodextrine, diphenyl carbonate	Solid dispersion technique
21.	Ganciclovir	β-cyclodextrine, CDI	Condensation polymerization method
22.	Gamma oryzanol	β-cyclodextrine	Encapsulation technique (for degradation)
23.	Glibenclamide	Ethyl cellulose, poly vinyl alcohol (PVA)	Emulsion solvent diffusion technique
25.	Glipizide	β-cyclodextrine, Ethyl cellulose, poly vinyl alcohol (PVA)	Solvent evaporation method
26.	Heparin	Diacrylated pluronic F127 solution, EDC	Photo polymerization
27.	Ibuprofen	Ethyl cellulose, poly vinyl alcohol (PVA)	Emulsion solvent diffusion technique
28.	Itraconazole	β-cyclodextrine	solvent technique
29.	Isoniazid	Ethyl cellulose, poly vinyl alcohol (PVA)	Emulsion solvent diffusion technique
30.	Ketoconazole	Ethyl cellulose, poly vinyl alcohol (PVA), DCM	Solvent evaporation method
31.	Lansoprazole	Ethyl cellulose, poly vinyl alcohol, pluronic F68	Emulsion solvent diffusion technique
32.	Lemongrass oil (LGO)	Ethyl cellulose, poly vinyl alcohol (PVA)	Emulsion solvent evaporation method
33.	Meloxicam	β-cyclodextrine, PMDA, DCM	Polymer condensation method
34.	Micanazole nitrate	β-cyclodextrine	Solvent evaporation technique
35.	Minoxidil	β-cyclodextrine, PMDA, DCM	Solvent evaporation technique
36.	Naproxen	Ethyl cellulose, poly vinyl alcohol (PVA)	Emulsion solvent diffusion technique
37.	Nateglinide	Ethyl cellulose, DCM	Ultrasound-assisted synthesis
38.	Nifedipine	β-cyclodextrine, DPC	Condensation polymerization method
39.	Nystatin	Ethyl cellulose, PVA, DCM, PMMA	Emulsion solvent diffusion technique
40.	Palcitaxel	β-cyclodextrine	Ultrasound-assisted synthesis
41.	Quercitin	β-cyclodextrine, DPC	Ultrasound-assisted synthesis
42.	Resveratrol	β-cyclodextrine	Ultrasound-assisted synthesis
43.	Rilpivirine	β-cyclodextrine	Solvent evaporation method
44.	Rutin	Ethyl cellulose, poly vinyl alcohol (PVA)	Emulsion solvent evaporation technique
45.	Salaiva officinalis	Ethyl cellulose, poly vinyl alcohol (PVA)	Polymer condensation method
46.	Simvastatin	Ethyl cellulose, poly vinyl alcohol (PVA)	Emulsion solvent diffusion technique
47.	Tomoxifen	β-cyclodextrine	Solvent evaporation method
48.	Telmisartan	β-cyclodextrine, DPC	Ultrasound-assisted synthesis
49.	Trimethoprim	Ethyl cellulose, poly vinyl alcohol (PVA)	Emulsion solvent evaporation technique
50.	Variconazole	Ethyl cellulose	Solvent evaporation method

 

Application of nanosponges:

Tumor concentrated on the usage of Nanoparticulate delivery device^[28];

The rational use of nanoparticles for tumor concentrated on is based on nanoparticles might be able to supply the amount of drug in closer to the tumor targeted cells via the improved permeability and active nanoparticles. Nanoparticles will lessen the drug exposure of health tissues with the aid of limited amount of drug disbursed to the focused organ.

 

Nanosponges for protein drug delivery^[23]:

Encapsulating potential examine of β-cyclodextrine based totally nanosponges in bovine serum albumin (BSA) turned into used as protein model. Protein can reversibly (a few times calmly irreversible) denature on Lyophilization from its native structure. To deliver the bovine serum albumin (BSA) protein with cyclodextrine primarily based, it growth the steadiness of nanosponge protein have also been used for immobilization of enzyme, encapsulation of protein, for control drug transport and stabilization.

 

Topical agents^{16, [29]}:

Nanosponge shipping system is a unique technology for the controlled release of topical agents of extended drug launch and retention of drug form on skin. An extensive style of substances may be incorporated right into a formulated product along with liquid, cream, powder, gel, ointment, or lotion. Econazole nitrate, an antifungal used topically to relive the signs and symptoms of superficial candidasis, dermatophytosis, versicolor and pores and skin infections available in cream, ointment and lotion.

 

Oxygen drug delivery^[30],[31]:

Cyclodextrin based nanosponges are used to evolved the oxygen drug delivery gadget. Characterized by way of the usage of α, β and γ Cyclodextrin these are suspended in water, saturated with oxygen and in-vitro characteristic. A silicone shape of membrane also can use for oxygen permeation with the help of nanosponge / hydrogel aggregate system.

 

Solubility enhancement^{[14], [32]}:

Nanosponges are used to enhance the solubility and dissolution rate of poorly soluble pills can providing the control released profile. However the molecular size and conformation are critical parameter influencing the inclusion complexation with nanosponges. Nanosponges of antifungal drug namely Itraconazole have greater solubility of poorly soluble drug the solubility will increase via 50 folds as compared to the ternary dispersion device.

 

Antiviral application^[33],[34]:

Nanosponges also are utilized in nasal, ocular, pulmonary routes of drug delivery system. It is specificity to deliver the antiviral drug on RNA to lungs or nasal route may be executed with the aid of nanocarriers for targeting the virus which may infect the RTI along with influenza virus, influenza virus and breathing sinctial virus, they can also used for HBV, HIV and HSV.

 

Enzyme immobilization^[35]:

Nanosponges had been widely used for stabilizing the enzyme. The issue of enzyme immobilization is in particular beneficial for lipase as it improves their stability and adjusts the properties which include enantio-selectivity and reaction rate.

 

CONCLUSION:

Nanosponges are advance drug delivery system as they carry hydrophilic and hydrophobic drugs by forming inclusion or non inclusion complex by increasing the solubilisation, stabilization and effective in the drug release, cellular internalization and site targeting. Nanosponges could expand the range of application of Cyclodextrin in pharmaceutical technology and medicine, as well as other important field, such as agriculture, environment and cosmetics. They could be used to deliver two active substances simultaneously for combination therapy, or for simultaneous therapeutic and diagnostic application. Nanosponges can be delivering by several routes such as oral (tablets and capsules), topical and parenteral in a predetermined manner to a targeted site. Nanosponges can be proved safe and effective and the Pharma industry will benefit for clinical studies can prove their possibility for human use.

 

CONFLICT OF INTEREST:

All authors declare that there is no conflict of interest.

 

AUTHORS’ CONTRIBUTIONS:

All the authors contributed equally to the paper.

 

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Received on 23.09.2019           Modified on 26.11.2019

Accepted on 29.12.2019         © RJPT All right reserved