Emerging Trends in ODF Formulation

Madhuri Sanjay Wable, Samruddhi Subhash Adsul, Jaydeep Babasaheb Pawar

Shantiniketan College of Pharamcy, Dhotre B.K., Parner, Ahilyanagar, Maharashtra, India.

*Corresponding Author E-mail: madhuriwable7@gmail.com

ABSTRACT:

The review highlights the versatility of preparation methods, particularly the solvent-casting production process, and novel 3D printing techniques that bring inherent flexibility. Three-dimensional printing technology not only diversifies active compounds but also enables a multilayer approach, effectively segregating incompatible drugs. For local and/or systemic drug delivery, Oro-dispersible films (ODFs) are thin, flexible, mechanically robust polymeric films that dissolve or disintegrate quickly in the oral cavity. Numerous facets of ODFs and their potential as a drug delivery system are examined in this review. Recent developments are briefed, including the thorough investigation of formulation ingredients like polymers and plasticizers. In addition to allowing for a multilayer approach and diversifying active ingredients, three-dimensional printing technology efficiently separates incompatible medications. An important advancement that increases the effectiveness of oral drug administration and expands the range of medications that can be administered through this route is the use of nanoparticles into ODF formulations. This review offers a thorough overview of the changing field of Oro dispersible drug delivery by illuminating the many in vitro evaluation techniques used to describe ODFs, ongoing clinical trials, approved commercial goods, and recent patents. Present-day patient-centric strategies include creating ODFs with features that are more patient-friendly, like better taste masking, simpler administration, and increased patient compliance, as well as tailoring ODF formulations to each patient's requirements. For quick advancement in the developing field of Oro-dispersible drug administration, it is essential to investigate new functional excipients that may improve the penetration of oligonucleotides, fragile proteins, and high-molecular-weight polar pharmaceuticals.

KEYWORDS: Oro-dispersible Film, 3D Printing, Nano-Particle Integration, Patient-Centric Drug formulation

INTRODUCTION:

Because of their high patient compliance, non-invasiveness, adaptability, scalability, ease of administration, and convenience for repeated and sustained usage, oral drugs are the recommended and generally accepted mode of drug delivery¹.

However, swallowing or chewing solid dosage forms, especially tablets and capsules, might be difficult for some patient groups, including the elderly, children, people with Parkinson's disease, and people recovering from anesthesia. It is estimated that over 15 million Americans, or 4.6% of the total population, suffer with dysphagia². To address the problem of swallowing difficulties, a great deal of work has been done to develop novel oral medicinal formulations that dissolve or scatter in the oral cavity. Furthermore, as has been shown elsewhere, highly vascularized oral mucosa may increase permeability to numerous drugs, resulting in a quicker beginning of action and higher bioavailability³.

Oral disintegrating tablets (ODTs) are a kind of solid oral dose form that dissolves quickly on the tongue in a few seconds without the need for chewing or water⁴. When inserted in the mouth, oral thin films—a medication delivery method made up of thin, flexible sheets—usually dissolve or disintegrate rapidly, often in a matter of seconds. They can be used to administer a range of pharmaceuticals, including prescription and over the counter (OTC) medications, and are designed to be applied to the tongue or cheek. Although the oral film dosage form is referred to by a number of names, including thin strip, oral film, orally dissolving film, quick dissolve film, melt-away film, and wafer, the European Medicines Agency formally classifies it as an Oro-dispersible film (ODF), or soluble films as the U.S. Food and Drug Administration (U.S. FDA) more commonly calls them. ODFs are sheets, either single or multilayered, made of suitable materials, and designed to dissolve quickly in the mouth, according to the European Pharmacopeial⁵. They quickly break down or dissolve in saliva to form a suspension or for solution, allowing for either a quick local effect or quick drug absorption and distribution into the bloodstream. Additionally, ODFs provide steady and quick drug release, which can increase some drugs' bioavailability. Because of its low enzymatic activity and extensive vascularization, the oral cavity may increase the bioavailability of medications with poor water solubility. For medications categorized as Class II and Class IV under the biopharmaceutical categorization system (BCS), this path is beneficia⁶. A relatively novel dosage form for oral administration, Oro-dispersible films (ODFs) are strips of thin polymeric films the size of postage stamps that dissolve or disintegrate nearly instantly when applied to the tongue.

Overview of Formulation and Technology:

The appearance, film thickness, tensile strength, percent elongation, drug content, disintegration time, dissolution rate, pH of ODF surface (which should be closed to the pH of the oral cavity), muco adhesiveness, moisture content, and homogeneity are some of the several significant characteristics of ODFs from a quality and/or technological standpoint. ODFs also need to be both robust and adaptable. Ph. Eur, on the other hand, provides very few specifications for ODF testing and manufacture. Tensile characteristics and release time are the two primary technological requirements outlined in Ph. Eur⁷.

ODF should therefore "possess suitable mechanical strength to resist handling without being damaged" and have a long enough duration of drug release⁸. It is important to note that the release time for ODFs is based on the specifications for traditional solid dosage forms, which may not be sufficient. The FDA, on the other hand, mandates that an ODF be compact, light (up to 500 mg), and dissolve in 30 seconds.

The ODF formulations are based on natural or synthetic film-forming polymers, along with additional ingredients such as plasticizers (agents that provide flexibility and improved mechanical properties), fillers, saliva-stimulating agents (which increase salivation and facilitate disintegration), disintegrants  or superdisintegrants, taste-masking agents (which mask the bitter and unpleasant taste of many APIs), coloring agents (which make the film more consumer-friendly), surfactants, enzyme inhibitors, stabilizers, and thickening agents. Not every manufactured ODF contains every set of chemicals listed above. ODF may have systemic or local effects, depending on the formulation (particularly the excipient composition)⁹

Fig. No.1 Excipients used in ODFs Formulation

The film-forming polymer, the amount of API particles in the films, and additional excipients all affect how long ODFs take to dissolve. Superdisintegrants are among the excipients employed in the composition of ODFs, as was previously indicated. The most common agents in this group are crospovidone, sodium starch glycolate, and croscarmellose sodium¹⁰. When they come into touch with saliva, their function is to shorten the breakdown time. Unfortunately, achieving the 30-second disintegration time is difficult. examined how two different kinds of super disintegrants affected the disintegration time of ODF loaded with a medicine that was poorly soluble in water. It was shown that the disintegration time decreased from 280 seconds to 160 seconds, which is much less than the ideal value of less than 30 seconds.

The matrix composition's formulation characteristics (polymer, surfactants, and other excipients) affect the disintegration time, however the surface area of the embedded particles mostly determines the dissolution time¹¹. Since Oro-dispersible films can potentially be used as a delivery system for low soluble APIs, a lot of work is done to increase dissolving and bioavailability. For example, complexation with cyclodextrins and the production of nano suspensions may be able to overcome the low solubility of Ari piprazole (APR) in water, which affects the rate of dissolution.

Wet milling, which reduces API particle sizes to submicron or nanoparticle levels, is another viable alternative. The bioavailability may be enhanced due to the direct proportionality between the particular particle surface area and the API's rate of dissolution¹².

Thus, embedding nanoparticles in ODFs is a promising way to increase the bioavailability of poorly water-soluble APIs. Steiner et al. conducted interesting studies in which they closely examined the effects of five different formulation strategies on API bioavailability: creating amorphous. Solid dispersions, embedding the APIs in lipid nano-suspension and lipid nano-emulsion, and embedding API nanoparticles or micronized API particles in the film-forming matrix.

Islam et al. suggested another intriguing strategy for improving bioavailability. Ebastine, a second medication of the BCS class, was added to transfersomes, a particular type of drug carrier, to improve its transmucosal distribution via the gastrointestinal tract. These were then incorporated into oral films to enhance certain tranfersome properties. This new carrier system was successful in delivering Ebastine, which is weakly soluble¹³.

Composition of Orodispersible Film:

Table No:1 Composition of Oro-dispersible Film

Sr No.	Composition of Film	Quantity
1	Active Pharmaceutical Agent	01-25
2	Film Forming Polymer	40-50
3	Plasticizer	0-20
4	Saliva Stimulating Agent	2-6
5	Sweetening Agent	3-6
6	Flavoring Agent	10
7	Coloring Agent	1

Personalized Therapy:

On a large scale, oral solid dosages (tablets or capsules) are frequently produced with limited dose variations¹⁴. Particularly for formulations containing APIs with a narrow therapeutic index, the restricted number of accessible dosages may result in undesirable treatment outcomes and adverse effects. Therefore, a variety of 3D printing processes, including fused deposition modeling (FDM), 3D inkjet printing, flexographic printing, and semi-solid extrusion (SSE) 3DP, have been employed to build ODFs in order to address these issues¹⁵. With the use of computer software (CAD), 3D printing allows for the extremely exact design of ODFs, reducing dose inaccuracy brought on by the films' uneven thickness during cutting.

3DP was brought to the pharmaceutical industry to offer a personalized drug delivery solution, allowing patients of all ages to get high-quality, adaptable care. By creating a customized product composition and design, these methods can meet each patient's unique demands. 3DP's strengths include precise drug loading and design flexibility. In particular, compared to other 3DP technologies, SSE 3DP is a promising technique that can be used to produce customized dosage forms at room temperature without requiring the preparation of drug-loaded filaments. For this reason, SSE 3DP is simpler to implement in community pharmacies and hospitals. Individual ODFs filled with levocetirizine dihydrochloride in dosages of 1.25mg, 2.5mg, and 5mg were successfully created using the SSE 3DP approach¹⁶.

Superdisintegrants:

Without the need for water, orodispersible tablets dissolve and/or disintegrate quickly in saliva. Certain tablets are actually fast-dissolving tablets since they dissolve in saliva in a matter of seconds. Others, which may take up to a minute to fully dissolve, are better referred to as fast-disintegrating tablets because they contain substances that speed up the rate of tablet disintegration in the oral cavity. This pill dissolves instantly when placed on the tongue, releasing the medication, which then dissolves or spreads in the saliva. As saliva travels down into the stomach, certain medications are absorbed from the mouth, throat, and oesophagus. In these situations, the drug's bioavailability is noticeably higher than that of the typical tablet dose form¹⁷.

Fig.No.2 ODF design scheme for QR reading, quick disintegration and improved dissolution

Pharmaceutical companies are developing NDDS in response to the need to administer medications to patients effectively and with the fewest possible negative effects. Solid dosage forms, such as tablets, are difficult for elderly and pediatric patients to swallow. The best answer for this issue is an orodispersible tablet that dissolves or disintegrates quickly in the oral cavity. They also provide a pleasant mouthfeel. Benefits of orodispersible tablets include enhanced bioavailability, rapid onset of action, and patient compliance¹⁸. Oral dissolving tablets are a desirable substitute for traditional tablet dose forms and liquids. Super disintegrants are substances added to tablet formulations that encourage the tablet to break up into smaller pieces in an aqueous environment, increasing the surface area available and facilitating a quicker release of the medicinal molecule.

Ideal characteristics:

1. It should result in quick breakdown.

2. Enough compactness to make fewer friable tablets.

3. Effective when concentration is low.

4. Have a higher rate of disintegration.

Fig.No.3 Disintegration of Tablet by Wicking and Swelling method

Mechanism of Superdisintegrants:

There are mainly four Disintegration of Tablet are as follows

1. Swelling: Swelling is the most often acknowledged overall mode of action for tablet disintegration. High porosity tablets disintegrate poorly because they don't have enough swelling force.

        On the other hand, the tablet with poor porosity experiences enough swelling force. It is important to remember that a very high packing fraction prevents fluid from penetrating the tablet and slows down disintegration once more ¹⁹.

2. Porosity and Capillary Action [wicking]: Capillary action disintegration is always the initial stage. The tablet breaks into fine particles when it is submerged in an appropriate aqueous medium because the medium seeps into the tablet and replaces the air that has been adsorbed on the particles, weakening the intermolecular connection. Water uptake by tablet depends upon hydrophilicity of the drug/excipient and on tableting circumstances. Maintaining a porous structure and low interfacial tension towards aqueous fluid are essential for these kinds of disintegrants because they aid in disintegration by forming a hydrophilic network surrounding the drug particles²⁰.

3. Particle Repulsive Forces: The swelling of tablets manufactured with "nonswellable" disintegrants is attempted to be explained by another disintegration mechanism. Guyot-Hermann's particle repulsion theory was founded on the finding that non-swelling particles also contribute to tablet disintegration. Water is necessary for the disintegration mechanism, which is the electric repulsive interactions between particles. Researchers discovered that wicking takes precedence over repulsion²¹.

4. Due to Deformation: Disintegrated particles undergo deformation during tablet compression, and upon contact with water or aqueous fluids, these distorted particles return to their original shape. On occasion, when granules were distorted during compression, the starch's ability to swell was enhanced. The tablet breaks apart because of the distorted particles' increased size.

Fig.No.4 Disintegration by Deformation and repulsion

List of Superdisintrgrants Used in ODF:

1. Sodium croscarmellose (CCS)

Mechanism: wicking plus swelling.

Notes: popular, strong swelling power; can have a significant impact on film flexibility.

Starting concentrations in ODF are typically between 0.5 and 3% w/w.

2. Cross-linked PVP, or CP, or crospovidone

Capillary wicking and strain-recovery (rapid fluid absorption without significant volumetric swelling) are the main mechanisms²².

Notes: great for breaking up quickly without causing too much film expansion.

Starting concentrations are typically between 0.5 and 2% w/w.

3. SSG, or sodium starch glycolate

High swelling capacity is the mechanism.

Notes: highly effective, but excessive use may cause significant swelling that compromises the integrity of the thin layer²³.

Starting concentrations are typically between 0.5 and 2% w/w (use lower in thin ODFs).

4. L-HPC, or low-substituted hydroxypropyl cellulose:

Mechanism: capillary action plus edema.

Notes: enhances disintegration while preserving mechanical strength and works with a variety of film formers.

Starting concentrations are typically between 0.5 and 3% w/w.

5. Starch that has been pre gelatinized (such as Starch 1500):

Mechanism: a rise in edema and porosity.

Notes: can affect gloss and look; frequently used when a natural polymer is sought.

1–3% w/w is the usual initial concentration.

6. Variants of colloidal silica and microcrystalline cellulose (MCC) (as wicking aids):

Mechanism: mostly not pure swelling but wicking/porosity (colloidal silica).

Notes: frequently used to enhance wetness and breakage in conjunction with other disintegrants.

Usually used in small amounts (≤1% to 2%)

7. Alginates, such as sodium alginate:

Mechanism: gelation and swelling; when hydrated, it can occasionally be used for quick disintegration.

Notes: use with caution as it may change mouthfeel.

Table no. 2 Parameters Influencing the Swelling Behavior of Superdisintegrants

Parameters	Effects
Amount of Superdisintegrants	A minimum amount of superdisintegrant is necessary for the development of sufficient swelling to outer membrane
Additives	Polymeric binders can reduce swelling pressure by special separation of superdisintegrants particles or competition for free water
Ionic strength of the medium	Competition of the ions for free water
ph value	Swelling can be influenced for the superdisintegrants with ionizable groups

Effect of Fillers:

The rate and mechanism of tablet disintegration are influenced by the solubility and compressive properties of fillers. Because soluble fillers dissolve in water, they are more likely to dissolve than to disintegrate²⁴. Using them may also raise the viscosity of the penetrating fluid, which tends to decrease the efficiency of powerfully swelling disintegrating agents. With enough disintegrants, insoluble diluents cause rapid disintegration.

Due to its amorphous nature and lack of solid planes on which the disintegration pressures can be applied, tablets containing spray-dried lactose (a water-soluble filler) dissolve more slowly than tablets containing crystalline lactose monohydrate.

Effect of Binders:

The disintegrating period of the tablet increases with the binder's binding capacity, which counteracts the quick disintegration. The tablet's disintegration time may even be impacted by the binder's concentration²⁵.

Effect of Lubricants:

Lubricants are often employed in smaller amounts than any other element in the tablet formulation since they are hydrophobic²⁶. Lubricant particles may stick to the other particles' surfaces when the mixture is blended. This hydrophobic coating prevents moisture and, as a result, the disintegration of tablets. If a pill contains no disintegrants or even a high concentration of slightly swelling disintegrants, lubricant has a significant detrimental effect on the water intake. Conversely, if there is a significantly swollen disintegrant in the pill, it little affects the disintegration time²⁷.

Methods of Adding Disintegration:

A disintegrating agent may be introduced at both processing stages, either before granulation (intragranular) or before compression (post granulation, or extragranular). Tablets can be broken up into granules with the help of an extragranular fraction of disintegrant (typically 50% of the total disintegrant required), and the granules further erode into fine particles when disintegrants are added intragranularly.

Tablet Manufacturing Method:

1. Direct Compression

2. Granulation

1    Direct Compression:

The procedure of compressing tablets straight from a powdered mixture of API and appropriate excipients is known as "direct compression." The powder blend does not need to be pretreated using a wet or dry granulation process²⁸.

Manufacturing steps for Direct Compression:

There are relatively few steps involved in direct compression:

· Milling of Drug and Excipient

· Mixing of Drug and Excipient

· Tablet Compression

2    Granulation:

Granulation is a process of size growth that transforms tiny particles into larger, more robust agglomerates.

Granulation Techniques:

1. Dry Granulation

2. Wet Granulation

Dry Granulation:

Slugging can be employed to create granules when tablet ingredients have adequate intrinsic binding or cohesive qualities and are either moisture-sensitive or cannot tolerate hot temperatures during drying²⁹. This process is known as double compression, pre-compression, or dry granulation. Because fine powders are more likely to flow into large cavities, slugging is used to make large tablets into slugs. Either by hand or in massive quantities using Fitzpatrick or comparable grinding mills, these compressed slugs are ground through the ideal mesh screen. The granulation is then carefully mixed with lubricants and compressed to create tablets. The alternative is to use a machine like a chillionator to pre-compress the powder using pressure rolls.

Two main dry granulation process:

I. Slugging Process: Slugging is the technique of compressing dry tablet formulation powder using a tablet press that has a die cavity big enough to fill rapidly. The slug's condition or accuracy is not very significant³⁰. It is only appropriate to apply enough pressure to condense the powder into homogenous slugs. After slugs are created, they are screened and milled to the proper granule size for final compression.

II. Roller Compaction: A device known as a chillonator can also be used to compress powder using a pressure roll³¹. The chilsonator produces a compressed material in a continuous, steady flow, in contrast to a tablet machine. The hopper, which has a spiral auger to feed the powder into the compaction zone, feeds the powder down between the rollers. The aggregates are crushed or screened to create granules, just like slugs.

Wet Granulation:

Wet granulation is the most popular agglomeration method in the pharmaceutical sector. The distinctive steps of the wet granulation process include wet massing of powders, wet sizing or milling, and drying³². The process essentially consists of wet massing the powder blend with a granulating liquid, wet sizing, and drying.

Orodispersible Tablet:

Tablets are the most widely used dosage form available today due to their ease of self-administration, compact size, and simplicity of manufacturing; however, hand tremors, dysphasia in elderly patients, young people's underdeveloped nervous and muscular systems, and uncooperative patients' difficulty swallowing are common occurrences that result in low patient compliance.

Orally disintegrating tablets (ODT) and mouth dissolving tablets (MDT) have become substitute oral dose forms in order to get around these problems³³. These are new kinds of pills that dissolve, disseminate, and break down in saliva in a matter of seconds. The ODT should disperse or disintegrate in less than three minutes, per the European Pharmacopoeia³⁴. The fundamental method for creating MDT involves using super disintegrants such as sodium starch glycolate (Primogel, Explotab) and cross-linked carboxymethylcellulose (Croscarmeliose).

Polyvinylpyrrolidone (Polyplasdone), for example, which dissolve tablets instantly when placed on the tongue, releasing the medication into the saliva³⁵.

Pre gastric absorption of saliva containing dispersed pharmaceuticals that flow down into the stomach and oral cavity absorption of drugs may both boost the bioavailability of some medications.

Definition:

A fast-dissolving drug delivery system, in most cases, is a tablet that dissolves or disintrigrants in the oral cavity without the need of water or chewing³⁶. Most fast-dissolving delivery system films must include substances to mask the taste of the active ingredient. This masked active ingredient is then swallowed by the patient's saliva along with the soluble and insoluble excipients.

These are also called melt-in-mouth tablets, repimelts, porous tablets, oro-dispersible, quick dissolving or rapid disintegrating tablets³⁷.

Requirement of ODFs:

An Ideal Orodispersible should be:

· Dissolve, disperse, and disintegrate in the mouth in a matter of seconds without the need for water when taken orally.

· Possess a pleasant mouthfeel.

· Possess a respectable ability to disguise taste.

· Be more resilient and less brittle

· After administration, leave little to no residue in the mouth.

· Show minimal susceptibility to external factors, such as humidity and temperature.

· Permit the production of tablets using standard processing and packaging tools.

Advantages of Orodispersible Film:

The highly vascularized oral mucosa offers improved absorption, increased bioavailability, a faster beginning of activity, and resistance to the first pass effect. Unlike other traditional dose forms, a thin film degrades quickly³⁸.

Unlike commercially available oral rapid disintegrating pills, which require specific packaging, thin films are easier to carry and are less friable. Additionally, a unit dose of the strip does not need the secondary holder to be carried. Addressing the poor stability or instability of liquid dosage forms is crucial, especially for aqueous formulations where patients may be less receptive if the dosage is not precisely measured and the bottle is shaken before administration³⁹.

A larger surface area offers a better platform for rapid dissolution and disintegration, which releases the medication into the oral cavity. There is no risk of choking, and they provide rapid release and precise dosage with improved patient compliance. These strips have superior adherence and are less fragile than oral dissolving tablets. ODFs in a blister pack make it easier to transport and use medication whenever and wherever needed without the need for water.

Disadvantages of ODFs:

· These ODFs do not allow for the addition of higher doses, unlike oral dissolving tablets. Because of its hygroscopic nature and the need for specific packaging, longer preservation is problematic⁴⁰.

· It is not possible to deliver medications that are unstable at buccal pH.

· Expensive methods for making these films as opposed to oral dissolving tablets.

· Restrictions on eating and drinking for a considerable amount of time following ODF consumption⁴¹.

Ideal Characteristics of ODFs:

· It should have a pleasant mouthfeel.

· should dissolve quickly in the sublingual cavity in a matter of seconds.

· not need water to absorb

· No residue should be left in the mouth.

· ought to show minimal sensitivity to specific environmental factors, such as humidity and temperature.

Classification of ODFs:

There are three types of ODFs:

1. Flash release.

2. Mucoadhesive melt-away wafer.

3. Mucoadhesive sustained release wafers.

Active Pharmaceutical Ingredient: The rapid dissolving oral film innovation has potential for conveyance of variety of APIs. Since the size of the dosage form is constrained, incorporating high dose of molecules into thin films is challenging task [42]. A typical composition of the orodispersible film contains 1-25% w/w of the drug. Wide variety of APIs can be conveyed through rapid dissolving films such as anti-diarrheal agents (loperamide), anti-asthmatic agents (salbutamol sulphate), cardiovascular, anti-epileptic, antiemetic, analgesics, anti-allergic, anxiolytics, hypnotics, diuretics, anti-parkinsonism agents, and drugs used for erectile dysfunction, anti-Alzheimer’s, expectorants, antitussive can formulated as film.

Polymers used in ODFs:

Although polymers are regarded as excipients, they have become an important component in film design, contributing to several of the films' characteristics [43]. Therefore, understanding the rheology and physicochemical properties of polymers is crucial to maximizing their use in the production of ODFs.

In order to provide a thin matrix with quick disintegration, good mechanical qualities, and organoleptic sensations, ODFs are primarily formulated using water-soluble polymers, which can be natural, semisynthetic, or synthetic. Hydrophilic cellulose derivatives, such as polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), or polyethylene oxide (PEO), are frequently used.

Chitosan:

Because of its crystalline form, chitosan, a naturally occurring cationic polymer made up of a linear sequence of monomeric units connecting 2-acetamido-2-deoxy-D-glucopyranose and 2-amino-2-deoxy-D-glucopyranose via β (1 → 4) glycosidic linkages, is only soluble in aqueous acidic solutions [44]. Among the many beneficial qualities of chitosan are its biodegradability, biocompatibility, low toxicity, antibacterial properties, and—most importantly—its superior mucoadhesive property, which is essential for the creation of films. It is essential to take into account the molar mass, particle size, and concentration in the chitosan solution in order to create the proper ODFs. Although chitosan films showed remarkable flexibility and tensile strength, their mechanical strength decreased when super-disintegrating agents were added.

Pectin:

Poly α1–4-galacturonic acids make up the majority of pectin, an anionic polysaccharide found in nature. Its varied qualities and uses in different fields are a result of the different amounts of amidation and methylation in its composition [45]. There is little data on pectin's use as a film-forming substance in ODF formulations, despite the fact that it has been used in a variety of drug delivery systems, including gel beads, films, and matrix tablets.

Polyvinyl Alcohol:

PVA is a synthetic polymer that comes in granular or powdered form and has a semi-crystalline or linear texture. It can tolerate high temperatures, is usually whitish or creamy, tasteless, odorless, non-toxic, and biocompatible. The industry offers PVA in a range of grades that differ according to the degree of hydrolysis and viscosity. The production of ODFs based on PVA has successfully accomplished the amorphization of the weakly soluble medication phenytoin by employing the solvent casting technique.

Pullulan:

A naturally occurring, neutral polymer called pullulan was isolated from Aureobasidium pullulans' fermentation media. Notably, it is translucent, flexible, non-toxic, biocompatible, and biodegradable, and it has outstanding mechanical and film-forming properties along with low oxygen permeability [46]. The solvent casting process was used to create pullulan-based ODFs with amlodipine besylate, and the results showed satisfactory mechanical characteristics, dissolving, disintegration times, and toxicity [47]. It has been reported that iron-loaded pullulan-based ODFs have been developed and characterized.

CONCLUSION:

Orodispersible films (ODFs) have become one of the most promising developments in oral drug administration because of their increased patient compliance, faster disintegration, and better bioavailability. The choice of appropriate plasticizers, film-forming polymers, and particularly superdisintegrants—which are essential for attaining the best disintegration and dissolution properties—is a significant component in the formulation of ODFs. By making it possible to deliver medications with a high molecular weight and poor solubility, the use of nanoparticles has further broadened the application of ODFs.

Furthermore, by enabling accurate dosing, layered designs, and the separation of incompatible medications inside a single dosage form, the integration of 3D printing technology presents an unparalleled possibility for personalized medicine.

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Received on 05.11.2025      Revised on 19.12.2025

Accepted on 24.01.2026   Published on 10.04.2026

Available online from April 13, 2026

Asian J. Res. Pharm. Sci. 2026; 16(2):172-180.

DOI: 10.52711/2231-5659.2026.00027

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