Microsponge Drug Delivery System: Emerging Technique in Novel Drug Delivery System and Recent Advances

 

Anshika Choudhary*, Md. Semimul Akhtar

Shri Ram Murti Smarak College of Engineering and Technology, (Pharmacy),

Bareilly 243202, Uttar Pradesh, India.

*Corresponding Author E-mail: anshikachoudhary50@gmail.com, akhtar.mpharm@gmail.com

 

ABSTRACT:

A number of advancements have been made in the drug delivery system in order to achieve the goals of improved efficacy and cost-effectiveness in therapy. Controlling the rate of release of active drugs to a predetermined site in the human body has been one of the pharma industry's most challenging tasks. Microsponges are porous cross-linked, non-collapsible microspheres with a size range of 5-300µm that can entrap a variety of drugs and then be incorporated into a formulated product like gel, cream, powder, or liquid. Controlled release of drugs onto the epidermis with the confidence that the drug remains primarily localized and does not enter the systemic circulation in substantial amounts is a field of research that the microsponge delivery system is progressively exploring. In order to remove systemic exposure and minimize local cutaneous reaction to active drugs, microsponge technology has been introduced in topical drug products to facilitate the controlled release of the active drugs into the cell. Also, numerous studies have shown that microsponge systems are non-irritating, non-mutagenic, non-allergenic, and non-toxic. MDDS technology is being used currently in cosmetics, over-the-counter (OTC) skin care, sunscreens, and prescription products and has recently been used in oral drugs as well as biopharmaceuticals (protein, peptides, and DNA based therapeutics) drug delivery. The purpose of this article is to provide information about microsponges such as the method of preparation, mechanism of drug release from microsponges, characterization, applications of microsponges, and information about microsponges updated research.

 

KEYWORDS: Microsponges, Controlled release, Topical formulation, Microsponge drug delivery system (MDDS), Novel drug delivery system (NDDS).

 

 


INTRODUCTION:

The advancements in delivery methods are being used to improve the efficacy and cost-effectiveness of the therapy. The challenges faced by the drug development industry are sustained release technology for reducing irritation of a wide range of APIs and other skincare actives thereby increasing patient/client compliance and results, enhanced formulation stability ensuring long term product efficacy and extended shelf life, superior skin feel and exceptional product esthetics1.

 

Microsponges are comprised of highly cross-linked, polymeric porous microspheres consisting of numerous interconnected voids in the particle, loaded with an active pharmaceutical agent within a collapsible structure. Microsponges have a large porous surface to entrap a wide range of active pharmaceutical agents in different doses that can be released at the desired site of absorption. The pores of microsponges form continuous arrangement open towards the exterior surface of microsponges which allows the outward diffusion of the entrapped drug with a controlled rate depending upon the size of the pores2.

 

Because of their limited efficiency as delivery systems, many conventional delivery methods require high concentrations of drugs to be incorporated for effective therapy. As a result, there is a need for delivery methods that maximize the period of time an active substance is available on the skin's surface or within the epidermis while decreasing its transdermal penetration into the body. Such conditions are uniquely satisfied by microsponge-based polymeric microspheres. Microsponges are manufactured in a number of ways, including emulsion systems and suspension polymerization in a liquid-liquid system. The most common emulsion system used is oil-in-water (o/w), with the microsponges being produced by the emulsion solvent diffusion (ESD) method3. Topical medicine application has a number of drawbacks, including ointments that are typically unattractive, greasiness, stickiness, and etc. that often result in a lack of patient compliance. In some research studies also uncontrolled evaporation of active agents, unpleasant odour potential incompatibility of drug with vehicles. As a result, there is a need for a system that maximizes the amount of time an active ingredient is available on the skin's surface or within the epidermis while decreasing transdermal penetration into the body. These conditions are met by the microsponge delivery system4.

 

Need of microsponges in topical drug delivery:

Topical agents are administered on skin that acts on the outer layers of skin. Though there is improved efficacy of certain drugs through topical route, it encompasses problems like lack of patient compliance due to greasy, sticky feel in case of ointments, irritation and allergic reactions in some individuals, uncontrolled evaporation of drug, objectionable odour, and drug vehicle incompatibility issues. Also, there is a lack of efficient vehicles for controlled and localized drug delivery in the stratum corneum and underlying layers. Due to the low efficiency of the topical delivery system, a high concentration of active ingredients needs to be added to the vehicle. When the formulation is applied, there is a rapid release of the drug which leads to the rapid absorption of the drug in the skin that causes excessive accumulation of active ingredients which in turn produces irritation and allergy of skin. So, there is a need to increase the amount of drugs either on the skin surface or within the epidermis and reduce transdermal penetration. In such cases, a microsponge drug delivery system (MDDS) is used for effective drug delivery while significant reduction in irritation effects of some drugs without compromising their efficacy. As microsponges are tiny, non-destructible spheres, and inert instead of passing through skin layers they get trapped in crannies of skin and small holes and release the therapeutic agent by controlled diffusion as needed by skin, thereby avoiding the unnecessary accumulation of therapeutic agents in skin layers5,6.

 

Merits of Microsponges technology:7,8

Microsponges have the following benefits over other micro particulate systems:

·       Microsponges may absorb up to six times their weight in oil without drying.

·       It has a continuous activity for up to 12 hours, i.e., it is extended-release.

·       Improved product elegancy, lessen the irritation and better tolerance leads to improved patient compliance.

·       It can also improve efficacy in treatment, they have better thermal, physical and chemical stability.

·       These are non-irritating, non-mutagenic, non-allergenic, and non-toxic.

·       MDDS allows the incorporation of immiscible products, they have superior formulation flexibility, in contrast to other technologies like microencapsulation and liposomes.

·       MDDS has a wide range of chemical stability, higher payload, and are easy to formulate, liquids can be converted into powders improving material processing.

 

Merits of Microsponges over other formulations:

Conventional formulations:

Topical drug formulations are often intended to function on the skin's outer layers. These products release their active components after application. They give a concentrated active ingredient layer that is quickly absorbed. This results in an excess of active ingredients accumulating in the epidermis and dermis. A microsponge system can significantly reduce side effects of a drug, such as irritation, without affecting its efficacy, as evidenced in MDS benzoyl peroxide formulations, which have good efficacy with minimum irritation9.

 

Micro and Nano formulations:

Microsponge is currently of great interest to pharmaceutical firms, particularly those that create controlled topical dosage forms. Microsponges have an advantage over lipid nanoparticles, nanotubes, niosomes, liposomes, microspheres, etc. in terms of drug compatibility, high drug loading capacity, controlled release, physical, chemical, and microbial stability10-16.

 

Limitations of MDDS:17

·       Organic solvents, which are hazardous to the environment, are used in the formulation of microsponges.

·       Some solvents are highly inflammable that possess a safety hazard.

·       Toxicity and health hazards were observed in cases where traces of residual monomers remained.

 

Characteristics of Microsponges:18-20

Characteristics of microsponges are as follows:

·       The pH of microsponge formulations is steady from pH 1 to 11.

·       Microsponge compositions can withstand temperatures of up to 130 ˚C.

·       Most vehicles and ingredients are compatible with microsponge formulations.

·       Microsponge formulations are self-sterilizing and bacteria cannot penetrate their typical pore size of 0.25μm.

 

Various drugs used in microsponge technology:21,22

·       Ibuprofen (NSAID)

·       Benzoyl peroxide (Anti-acne)

·       Fluconazole (Anti-fungal)

·       Tretinoin (Vitamin-A)

·       Trolamine (Analgesic)

 

Polymer for formulation of MDDS:23

·       Eudragit RS 100

·       Ethyl cellulose

·       Polyvinyl acetate

·       Carbopol 940

·       Polystyrene

·       Eudragit EPO

 

Method of preparation:24

According to the physicochemical properties of the drug, the process of drug loading in microsponges is as follows:

 

1. One Step Process:

An inert, non-polar drug is loaded through this process. This type of drugs creates porogen that is porous structure. Porogen is stable to free radicals.

 

2. Two Step Process:

This process is employed when the drug is susceptible to a polymerization environment. Under mild experimental conditions, a substitute porogen is used during polymerization and is replaced with an active substance.

Following are some preparation methods of microsponges.

1.     Liquid-liquid Suspension polymerization method

2.     Quasi emulsion solvent diffusion technique

3.     Water in oil in water (W/O/W) emulsion solvent technique

4.     Addition of porogen method

5.     Oil in oil (O/O) emulsion solvent diffusion technique

6.     Lyophilisation method

7.     Vibrating orifice aerosol generator method

8.     Ultrasound assisted method

9.     Electro hydrodynamic atomization method

 

Out of these following methods liquid-liquid suspension polymerization method and Quasi emulsion solvent diffusion technique are widely acceptable.

 

Liquid-liquid Suspension polymerization      method:25, 26

Microsponges are prepared by a suspension polymerization process in liquid-liquid systems (one-step process). Firstly, the monomers are dissolved along with active ingredients (non-polar drug) in an appropriate solvent solution of monomer, which is then dispersed in the aqueous phase with agitation. The aqueous phase typically consists of additives such as surfactants and dispersants (suspending agents) etc in order to facilitate the formation of suspension. Once the suspension is established with distinct droplets of the preferred size then, polymerization is initiated by the addition of a catalyst or by increasing temperature as well as irradiation. The polymerization process results in the formation of a reservoir-type structure with pores at the surface. During the polymerization, an inert liquid immiscible with water however completely miscible with monomer is used to form the pore network in some cases. Once the polymerization process is complete, the liquid is removed leaving the Microsponges which are permeated within preformed Microsponges then, incorporate a variety of active substances like anti-fungal, rubefacients, anti-acne, anti-inflammatory, etc and act as a topical carrier.

 

Quasi emulsion solvent diffusion technique:27-29

A quasi-emulsion solvent diffusion approach (two-step procedure) was also used to make porous microspheres (Microsponges) using an internal phase-containing polymer such as Eudragit RS 100 dissolved in ethyl alcohol. Then, the drug is slowly added to the polymer solution and dissolved under ultrasonication at 35˚C, and a plasticizer such as triethyl citrate (TEC) was added in order to aid the plasticity. The inner phase is then poured into an external phase containing polyvinyl alcohol and distilled water with continuous stirring for 2 hours. After that, the Microsponges were separated by filtering the mixture. The product (Microsponges) was washed and dried in an air-heated oven at 40°C for 12 hrs.

 

Drug release mechanism from microsponges:30,31

The active ingredient entrapped in microsponges can be released over time by one or more external stimuli or triggers.

 

Table 1: Various Drug release mechanism from microsponges

Release Mechanism

Description

Temperature triggered release

In this mechanism, due to temperature change, active ingredient released through the system. Some drugs are often too viscous at room temperature so they cannot flow impulsively from porous system. But when applied to skin, increase in temperature of skin leads to increased flow rate and thus continuous release of drug.

Pressure triggered release

In this mechanism, when pressure is applied to the skin or a dosage form is rubbed against it, the entrapped drug is released via microsponges.

Solubility triggered release

Porous systems incorporated with water soluble excipients releases drug in presence of water. Sometimes release is driven by diffusion mechanism by considering partition coefficient between drug and external system.

pH triggered release

In this mechanism, change in pH triggers drug release and is achieved by modification of coating on microsponges for pH-based actives.

 

Evaluation of microsponges:

Particle size and size distribution:

Particle size and its distribution evaluation is a very crucial parameter as the size of the particle affects texture, stability of formulation and is determined by using either a light microscope or electron microscope. The particle size of loaded as well as unloaded microsponges is determined by using laser light diffractometry. Cumulative percentage drug release from Microsponges of different particle sizes will be plotted against time to study the effect of particle size on drug release. Particles larger than 30μm can impart a gritty feeling and hence particles of sizes between 10 and 25μm are preferred to use in final topical formulation32.

 

Morphology and surface topography of microsponges:

Prepared microsponges can be coated with gold-palladium under an argon environment at room temperature for morphology and surface topography, and then the surface morphology of the microsponges can be analyzed using scanning electron microscopy (SEM). SEM of a fractured microsponge particle can also be taken to illustrate its ultra-structure33.

 

Dissolution study:

Microsponges in vitro drug dissolution data was obtained by using USP XXIII modified basket dissolution apparatus having 5m stainless steel mesh. The speed of rotation is maintained at 150 rounds per minute (rpm). Samples at various intervals are pipetted and analyzed using a suitable analytical method. Dissolution medium selected according to the solubility of active ingredient for maintaining proper sink conditions34.

 

Pore structure determination:

Pore diameter and volume are critical parameters that govern the duration of release and the movement of API from microsponges. Mercury intrusion porosimetry is used to characterize porosity parameters like pore diameter, size distribution, total pore SA, percent porosity, interstitial void volume, structure and morphology of pores, bulk, and true density35.

 

Compatibility study:

The compatibility of drugs with reaction adjuncts can be studied by thin-layer chromatography (TLC) and Fourier Transform Infra-red spectroscopy (FT-IR). The effect of polymerization on the crystallinity of the drug can be studied by powder X-ray diffraction (XRD) and Differential Scanning Colorimetry (DSC). For DSC approximately 5mg samples can be accurately weighed into aluminium pans and sealed and can be run at a heating rate of 15˚C/min over a temperature range 25–430˚C in an atmosphere of nitrogen36,37.

 

Polymer-Monomer composition:

The composition of the polymer influences the partition coefficient between the vehicle and the microsponge system, and thus the release rate of the entrapped drug. A plot of cumulative % drug release Vs time gives an idea about the release of entrapped drugs of various polymer compositions. Characteristics of the drug and the vehicle determine monomer selection38.

 

Cross-linking density:

The resiliency of microsponges can be modified by altering the amount of cross-linking monomer (DVB). Softer or firmer microsponges, according to the need can be prepared. Theoretical cross-linking density can be calculated from the following equation39.

 

Cross-linking density = Weight of DVB ˟ Purity of DVB/Total weight of monomer

 

Determination of Production yield:

The production yield of the microparticles was determined by calculating accurately the initial weight of the raw materials and the last weight of the microsponge obtained40.

Production yield (%) = Practical weight of microsponges/ Theoretical weight of Microspnges x 100

 

Applications of microsponges:41

Microsponge delivery system (MDS) improves the safety and efficacy of topical, oral, ophthalmic, over-the-counter (OTC) as well as personal care products. This drug delivery system has a variety of applications as described in table 3.

 

Table 3: Applications of microsponge system

S. No

Applications

Advantages

1

Anti-acne e.g., Benzoyl peroxide gel/lotion.

Maintained efficacy while causing minimal skin irritation and sensitivity.

2

Anti-fungal

Prolonged release of active drug.

3

Anti-inflammatory e.g., Hydrocortisone

Long term effect with reduced skin allergy.

4

Sunscreens

e.g., Oxybenzone gel

Long term product efficacy with enhanced skin safety against sunburns, sun related injuries even at high concentration.

5

Anti-dandruff

e.g., selenium sulphide.

Extended safety as well as efficiency reduced objectionable odour and minimum irritation.

 

Other applications of Microsponges:

In topical drug delivery:

Various drug-loaded microsponges are mixed into topical dosage forms like emulgel, cream, and powder. It improves drug residence time in the epidermis and dermis reducing the frequency of application. Also, side effects are reduced by using biocompatible, inert, non-toxic polymers. Microsponges have applications in topical drug delivery in hyperpigmentation disorder (Glabridin microsponges), in rheumatoid arthritis (Mefenamic acid microsponges), as anti-acne (Benzoyl peroxide microsponges), in diabetic wound healing (Nebivolol microsponges), and psoriasis (Clobetasol propionate microsponges)42.

 

In oral drug delivery:

Though the oral route is easy to access, safe, non-toxic, it possesses the disadvantage of rapid excretion of drugs due to the short half-life, extensive first-pass metabolism of some formulations. As a result, various microsponges formulations are being developed for controlled and targeted oral delivery, with a variety of applications.  Smaller microscopic particles have a higher surface area that increases the solubilisation rate. Ibuprofen microsponges for controlled drug delivery were created by varying the intraparticle density of Eudragit RS. By using the dry impact blending method, powder-coated microsponges of chlorpheniramine maleate are prepared for sustained release. Ketoprofen microsponges are prepared for controlled oral delivery and then formulated as tablets using the direct compression method43.

 

Reconstruction of vascular wall using Microsponge Technology:44

The tissue-engineered patch was created by combining a collagen-microsponge with a biodegradable polymeric scaffold made of polyglycolic acid knitted mesh, and reinforced on the outside with woven polylactic acid.

 

Recent advances in microsponge drug delivery system:45

Some researchers, pharmaceutical companies are developing advanced formulations. They are as follows and have greater stability than microsponges.

 

Nanosponges:

Nanosponges have been observed to be a good carrier for gas delivery. When cytotoxic is incorporated in the nanosponges carrier system, it increases the potency of the drug so it is used for targeting cancer cells. β-CD nanosponges are developed by cross-linking β-CD molecules with biphenyl carbonate. They can be used for hydrophilic as well as hydrophobic drugs.

 

 

Nanoferrosponges:

Nanoferrosponges are self-promising carriers with improved penetration towards a targeted area due to an external magnetic response that allows carriers to pass through deeper tissue and then exclusion of magnetic material, leaving a porous system behind.

 

Porous microbeads:

Porous microbeads were developed due to improved characteristics of microspheres. For developing solid porous microbeads, polymerization and cross-linking technologies are used. The high internal phase emulsion method uses a monomer that contains an external oil phase, internal aqueous phase, and cross-linker. The microbeads are utilized in topical, oral, and buccal drug delivery systems. This approach gives a new therapeutic route for siRNA delivery due to superior RNA stability and efficient siRNA encapsulation.

 

CONCLUSION:

The novel microsponge porous system offers several advantages over conventional formulations and has a wide range of applications in topical, oral, ophthalmic delivery of drugs. Originally designed, for topical drug delivery such as anti-acne, anti-inflammatory, anti-fungal, anti-pruritic, and so on, but nowadays, is also used for tissue engineering, and colon-specific drug delivery. Microsponge Drug Delivery System (MDDS) can entrap a wide variety of actives and then release them onto the skin at a time and in response to a trigger. It is a unique technology for the controlled release of topical agents that consists of microporous beads loaded with active agents and can also use for oral as well as biopharmaceutical drug delivery. Microsponge can be effectively incorporated into topical drug delivery systems for dosage form retention on the skin, as well as used for oral delivery of drugs using bio erodible polymers, particularly for colon-specific delivery and controlled release drug delivery system (CRDDS) thus improving patient compliance by providing site-specific drug delivery system and prolonging dosage intervals. Microsponge-based drug delivery is valuable, potential drug delivery system.

 

ACKNOWLEDGMENTS:

The authors would like to thank our college Shri Ram Murti Smarak College of Engineering & Technology, (Pharmacy), Bareilly, Uttar Pradesh, India for giving a great idea of microsponges giving in the present review.

 

CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this investigation.

 

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Received on 15.07.2021            Modified on 12.09.2021

Accepted on 12.11.2021           © RJPT All right reserved

Research J. Pharm. and Tech 2022; 15(10):4835-4840.

DOI: 10.52711/0974-360X.2022.00812