INTRODUCTION:

The fast-dissolving drug–delivery system was a novel drug delivery system that was first developed in the late 1970s. FDDS acts as an alternative to conventional dosage forms. FDDS undergo disintegration in an oral cavity within a minute and release the drug.

The first developed or manufactured fast-dissolving dosage form is a rapidly disintegrating tablet. FDDS has great importance in pharmaceutical field¹. Fast Dissolving Drug Delivery Systems has a benefit over the conventional dosage forms because dosage form quickly disintegrated, dissolves, and releases a drug without the need of water². oral route is a major route of drug delivery and number of dosage form deliver from this route. fast dissolving film is a novel delivery system for the delivery of pharmaceutical ingredients. the concept of the oral thin strip was based on the technology of the transdermal patch. The drug delivery system composed of a thin film. which is placed in the oral cavity and the film is wet by sublingual mucosa. Then the film is disintegrated and dissolves to release the drug molecules³. Pharmaceutical industries accept fast dissolving film as a practical and alternative to conventional over-the-counter dosage form such as tablets, capsules, and liquid dosage forms. Fast dissolving film offers fast, safe, and accurate dosing, without a need of water⁴.

Fast dissolving drug delivery system is suitable for the drugs which show high first-pass metabolism or hepatic metabolism, used to improve the oral bioavailability and reduce dosing frequency, which reduce side effect and as well as cost-effective.

Niosome is also known as nonionic surfactant vesicles. Noisome are closed bilayer vesicles formed by self-assembly of nonionic surfactant in an aqueous medium. Noisome acts as a drug carrier to deliver the drug to the site of action. Niosomes are vesicular carriers of non-ionic surfactants with a size range between 10 and 1000 nm. Noisome is analogous to liposomes but noisome increases the stability of entrapped drugs. Niosomes can be used for entrapping both hydrophilic and hydrophobic drugs⁵. Niosomeis flexible in nature. Due to the flexibility of their structure and ease of storage and handling. Niosomes are used for controlled release, targeting, and permeation enhancer.

Drug delivery by oral route show some problems such as hepatic first-pass metabolism and enzymatic degradation within the GI tract. For certain drugs, these problems can be overcome by their administration through sublingual mucosa⁶. The sublingual route can produce a quick onset of action within a short period of time due to high permeability and vascularisation of the sublingual mucosa. Fast dissolving strip is prepared using hydrophilic polymers that disintegrates within a few seconds⁷. It delivers the drug directly into the systemic circulation thereby bypass the hepatic first-pass metabolism. This delivery system comprises of a thin niosomal film, is simply place underneath the tongue, promptly wet by saliva; the film quickly disintegrates and release the drug for systemic absorption. This fast-dissolving action is mainly due to the large surface area of the film. (Figure No.1)

Features of Fast Dissolving Thin Strips/film⁸

· No need of water.

· Film are present in various shapes and size.

· Fast disintegration hence the quick onset of action.

· Film show fast dissolution.

· Thin elegant film

· Available in various size and shapes

· Fast disintegration

· Rapid release

Fig 1: - Structure of Oral Mucosa⁹

Advantages of Fast Dissolving Sublingual Drug Delivery^10,11

· Mask the bitter taste of the drug

· Stability improved

· Fast onset of action

· Better patient compliance

· Improved the bioavailability

· Accurate dosing

· No need or water

· Bypass the first-pass metabolism

· Large surface area for absorption

· No fear of chocking

Disadvantages of Fast Dissolving Sublingual Drug Delivery⁸

· Film kept in dry places because of hygroscopic in nature.

· Large dose drug cannot incorporate

· Special packaging should be required for the stability of the product.

METHODS:

Formulation of drug-loaded niosomes:

Niosomes were prepared by the Handshaking method (Thin film hydration technique) using span 60 as a nonionic surfactant and cholesterol provides membrane rigidity. The drug to surfactant ratios were 1:2 and the drug and cholesterol ratio was the same in all formulations. The drug, nonionic surfactant, and cholesterol were weighed and dissolved in chloroform in a round bottom flask. The solvent was evaporated at a temperature of 60°C under reduced pressure using a rotary evaporator to form a thin film on the flask wall. The film was moistenwith deionized water for half horat room temperature with gentle shaking. This film was hydrated with deionized water (10mL) and temperature maintained at 60°C. The subsequent niosomal suspension was blended by vortex mixing for 10 minutes and sonicated for 20 minutes at 25°C. The niosomal suspension was left overnight at 4°C and stored at refrigerator temperature (4°C–8°C) for further studies¹².

Characterization of Prepared Niosomes:

· Determination of entrapment efficiency

· Particle size and zeta potential

Determination of entrapment efficiency:

Niosomes containing drug were separated from the free drug by cooling centrifugation at 15,000rpm for 60 minutes at 4°C. The niosomal pellets were drooping in methanol and centrifuged again. The integrity of vesicles was not affected by centrifugation as reported in the literature. The washing procedure was repeated two times as reported previously. The supernatant was collected each time and assayed spectrophotometrically. The amount of entrapped drug was obtained by deducting the amount of free drug from the total drug¹². The percent of entrapment efficiency (EE%) was then calculated according to the given equation 1:

Amount of entrapped drug

EE% = ----------------------------------- ---------------- (1)

Total drug amounr

Particle size and zeta potential: -

The mean particle size (nm) and polydispersity index of the prepared niosomesformulation in both niosomal dispersion and niosomal film were measured by dynamic light scattering laser using a Zetasizer Nano ZS and thermoelectric temperature controller. The corresponding zeta potentials (mV) were determined by photon correlation spectroscopy using the same Zetasizer Nano instrument^3,12.

Ingredients Used in The Fast-Dissolving Films

· Film-forming polymers

· Plasticizers

· Sweetening agents

· Saliva stimulating agents

· Flavoring agents

· Coloring agents

· Superdisinteegrant

Film-forming polymers: -

Film-forming polymers are the polymers used to prepare a film. Generally used polymer in the formation of the film is hydrophilic in nature. The concentration range between 0-40%. The strength of film depends upon the type of polymer used. Polymer used either alone or some time in combination.

Ideal property of film-forming polymers:

· Non-irritant in nature.

· Polymer has good spreading property.

· It should odorless and tasteless.

· It should be hydrophilic in nature.

· Sufficient shelf life

· Polymer has excellent film-forming property¹³.

Both natural and synthetic polymers are used to prepare a film¹⁴.

Natural Polymer	Synthetic Polymer
Starch	Hydroxypropyl methylcellulose
Gelatin	Hydroxypropyl cellulose
Xanthan	Polyvinylpyrrolidone
Pectin	Polyvinyl alcohol
Pullulan	Carboxymethyl cellulose
Polymerised resin	Kollicoat
Maltodextrin	Hydroxyethyl cellulose

Plasticizers:

Plasticizers used to provide flexibility to film as well as reduce the brittleness of film. The concentration ranges from 1-20%. Plasticizers improve the mechanical strength of film such as tensile strength and elongation of the films. The main function performed by plasticizer is to decrease the glass transition temperature of the polymer between 40-60˚C for the non-aqueous system and below 75˚C for the aqueous system. Optimized amount of plasticizers are used to get better FDF’s. The selection of plasticizer depends upon its compatibility with film-forming polymer and ingredient of formulation¹.

Example of plasticizer

Propylene glycol, Glycerol, Polyethylene glycol- 400, Castor oil, Phthalate derivatives like diethyl and dimethyl phthalate, etc.

Sweetening agents:

Sweetening agents used to mask the bitter taste of the drug. Sweetening agents used alone or sometimes in combination, concentration ranges from 3-6%. Taste is the most important factor mainly inpediatric population⁹. Both natural and artificial sweeteners are used in fast-dissolving dosage forms¹⁵. But the natural sugar is limited in diabetic patients¹⁶.

Sweetening agents	Example
Natural sweeteners	Xylose, ribose, glucose, sucrose, maltose etc
Artificial sweeteners	Sodium or calcium saccharin salts etc
Dipeptide based sweeteners	Aspartame
Polyhydric Alcohols	Sorbitol, mannitol, etc
Protein-based sweeteners	Thaumatin I and II

Flavouring agents:

Flavouring agents used to provide a flavour to the formulation. Mainly used to mask the taste of the drug. The concentration of Flavouring agents between 1 to 2%. The selection of flavours depends on the age group of people¹⁷.

Example of Flavouring agents

Strawberry, Apple, Orange, Cherry, Mango, Peppermint, Vanilla, Citrus, Coffee, Cocoa, Pineapple, Menthol Etc

Superdisintegrants:

Superdisintegrants are the substances or mixture of substance added to a formulation to facilitate its disintegration after administration¹⁸.

Natural superdisintegrant	Synthetic superdisintegrant
Guar gum	Sodium starch glycolate,
Fenugreek seed mucilage	Crosspovidone
Mango peel pectin	Cross carmellose sodium

Coloring agents:

FD&C approved coloring agents which are incorporated up to 1% w/w¹⁹.

Example of Coloring agents

Titanium dioxide, Sunset yellow etc

Saliva stimulating agents: -

Saliva stimulating agents are the agent which increase the rate of production of saliva. the concentration ranges between 2-6%. Saliva stimulating agents added in fast dissolving film which result in fast disintegration so it can provide fast onset of action²⁰.

Example of Saliva stimulating agents

Citric acid, Tartaric acid, Ascorbic acid, Lactic acid, Malic acid

Various Methods for the Development of Fast Dissolving Sublingual Films:

Various methods used for the preparation of fast dissolving thin film include-

1. Casting and drying:

(a) solvent casting

(b) semi-solid casting.

2. Extrusion:

(a) hot melt extrusion

(b) solid dispersion extrusion

3. Rolling method:

Solvent casting method:

The solvent casting method is most widely used for the preparation of fast dissolving film. In this method, water-soluble ingredients are dissolved to form a clear viscous solution. The drug and other excipient are dissolved in another suitable solvent, then both the solution is mixed and removed the entrapped air. The resulting solution is cast into a Petri plate and dried^21,22(figure no 2).

Fig 2: Solvent casting method²³

Semi-solid casting method:

This method is generally used when the acid-insoluble polymer like cellulose acetate butyrate, cellulose acetate phthalate, etc., is used in the formation of the fast film. The ratio of water-soluble film-forming polymer and acid-insoluble polymer should be 4:1. The solution of water-soluble film-forming polymer is prepared in the semi-solid casting method. Then the water-soluble film-forming polymer is added to the insoluble polymer. Then add a suitable amount of plasticizer to get gel mass. The thickness of the film is about 0.015-0.05 inches¹⁰.

Solid dispersion extrusion:

The drug is converted into solution form by dissolving it in a suitable solvent and then the drug solution is added into a melted PEG below 70C. The drug solution is not miscible with melted PEG and the polymorphic form of drug precipitated in solid dispersion may be affected by solvent^24,25.

Hot-melt extrusion method:

In this method, heat is used to convert the polymeric solution into a film. In Hot melt extrusion method API and other ingredients are mixed in a dry state and then subjected to the heating process. The mixture is then expelled out in the molten state without using any solvent. The molten mass is then used to cast the film and then the film is cut into the desired size and shape. This process is not suitable for thermolabile ingredients. Optimization of the speed of casting and drying time is important from the commercial-scale output²⁶(figure no. 3).

Fig 2: Hot melt extrusion method²³

Rolling method:

In the rolling method, the film is formulated by preparation of pre-mix, by adding active and subsequent formation of the film. The pre-mix batch includes a polar solvent, film-forming polymer and other ingredients of formulation except drug added to the masterbatch feed tank. Then a known amount of the masterbatch is fed by the first metering pump and control valve. The desired amount of drug is added into the mixer and then blended for sufficient time to form a homogenized matrix. A specific amount of matrix is fed into the pan through the second metering pump. The film is finally formed on the substrate and carried away by the support roller. The wet is dried by using controlled bottom drying^27,28.

Preparation of Fast Dissolving Niosomal Films¹²

Evaluation of Sublingual Films

1. Organoleptic properties

2. Mechanical properties

· Thickness

· Tensile strength

· Folding Endurance

· Percent elongation

3. Surface pH test

4. Permeation studies

5. Scanning electron microscopy

6. Swelling Test

7. Percentage moisture loss

8. Contact angle

9. Disintegration time

10. Dissolution test

Organoleptic properties:

The films were evaluated for organoleptic characteristics like colour, odour and shape. Films were visually inspected for colour and shape²⁹.

Mechanical properties:

Thickness:

Thickness is considered an important parameter because it directly related to drug content uniformity so it become necessary to assure the accuracy of the dose of the drug in film. The thickness of the film is measured by micrometre screw gauze or calibrated digital Vernier calliper at different spot. The mean thickness was calculated and thickness of the film should be in the range of 5-200µm^30,31.

Tensile strength:

It is the maximum stress applied to a point of film at which the film starts breaking. A film should have good tensile strength. Load failureis a weight at which film break. It is calculated by the applied load at breakage divided by the cross-sectional area of the film³².Tensile strength was then calculated according to the given equation 2:

It is the maximum stress applied to Tensile Strength = Load at failure ×100/strip thickness

× strip width

Load at failure

Tensile Strength = ------------------------×100 (2)

strip thickness

Folding Endurance:

Folding endurance indicates the brittleness of film. It was determined by repeatedly folding the film at the same place till it breaks. The number of times it can be folded without breaking gives the value of folding endurance²².

Percent Elongation:

When stress is applied on the film, it starts stretching and this is referred to as strain. Strain is basically the deformation of film divide by original dimension of the film. It depends upon on the plasticizer added. Elongation of strip increases with increases in plasticizer concentration³³.Percent Elongation was then calculated according to the given equation 3:

Increase in lenth of strip

Percent Elongation =--------------------------------- × 100 (3)

Initial length of strip

Surface pH test:

The surface pH considered an important parameter because it can cause side effects to the oral mucosa.

Method 1- In this method, the film is placed on Petri plate and film is wet by using distilled water and the pH of the film is noted with the help of pH meter. This process is repeated for at least 6 films of each formulation and the mean is calculated³⁴.

Method 2- Prepared films was placed on 1.5% w/w agar gel and then the pH paper is placed on the film. Change in the color of pH paper indicates the surface pH of the film³⁵.

Permeation studies:

Permeability study was done by using Modified Franz diffusion along with porcine buccal mucosa. This Modified Franz diffusion cell consists of a donor and a receptor compartment. There is s donor and receptor compartments and mucosa was mounted between these two compartments. Then, the receptor compartment if filled with isotonic buffer pH 6.8 and temperature maintained at 37±C. The donor compartment contains a 1 ml simulated saliva fluid of pH 6.8. Thermodynamics was maintained by a magnetic bead stirrer at a speed of 50 rpm is used. samples were withdrawn at suitable time intervals and replaced with an equal amount of phosphate buffer from the receptor compartment. The % amount of drug in the receptor compartment was determined by measuring the absorbance^36,37,

Scanning electron microscopy:

SEM is an important to study thesurface morphology of the film between drug and different excipients. A film sample was taken and placed in sample holder and at ×1000 magnification and variousphotomicrographs were taken using the tungsten filament as source of electron³⁸.

Swelling Test:

The swelling properties of fast dissolving thin film was done by using simulated saliva solution²⁶. It is determined by using following equation 4:

Final weight (Wt) – Initial weight (Wo)

Degree of sewlling = --------------------------------------------------- (4)

Initial weight (Wo)

Percentage moisture loss:

To determine percentage moisture loss 3 films of area 2 × 2 cm2 was taken and weighed individually. Now the films werekept in desiccators containing fused anhydrous calcium chloride and film kept in desiccator for 72hr³⁹. After 72 hr, film is weighed again and the percentage moisture loss of films was measured by using the following equation 5:

(Initial weight – Final weight)

Percent moisture loss = --------------------------------------- × 100 (5)

Initial weight

Contact angle:

Contact angle measurement determine the wetting behavior, disintegration time, and dissolution of oral film. Goniometer is a device used to determine the contact angle (AB Lorentzen and Wettre, Germany) and the measurements should be done at room temperature. Double distilled water is used to determine the Contact angle. A drop of double distilled water is placed on the surface of dry film. Images of water droplet are recorded within 10 s of deposition with the help of digital camera. Digital pictures can be analyzed by imageJ 1.28v software (NIH, USA) for contact angle determination⁴⁰.

Disintegration time:

The disintegration time limit of 30 s or less for orally disintegrating tablets described in CDER guidance can be applied to fast dissolving oral film and no official guidance is available for oral fast disintegrating films, this may be used as a qualitative guideline for quality control test. Disintegration time is determined by using disintegrating test apparatus may be used for this study. Typical disintegration time for film is 5–30 s⁴¹.

Dissolution test:

Dissolution test is performed by using standard apparatus give in pharmacopoeia that is standard basket or paddle apparatus. Selection dissolution medium is important and selected as per sink condition and highest dose of drug. Dissolution medium maintained at 37 ± 0.5°C temperature and rpm at 50^41,4.

CONCLUSION:

Fast dissolving niosomal films are the novel approach in oral drug delivery systems. Absorptionby subligual route is greater than oral route. Sublingual route increases the bioavailability of drugs because the oral mucosa is highly vascularized so drug directly enters into the systemic circulation and avoid the first-pass hepatic metabolism. The sublingual niosomal film prolong the therapeutic effects of the drugs. Fast dissolving niosomal films have great importance during the emergency condition like allergy, short term spasm and asthma a whenever immediate onset of action is desired. Fast dissolving film are also suitable for pediatric, geriatric and dysphasic patients.

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Received on 14.03.2021 Modified on 07.11.2021

Res. J. Pharma. Dosage Forms and Tech.2022; 14(2):163-170.

DOI: 10.52711/0975-4377.2022.00026