Orally disintegrating dosage forms in epilepsy management: Formulation strategies,evaluation,and clinical potential

Abstract

Epilepsy is a neurological disorder that requires long-term pharmacological treatment. Conventional oral antiepileptic dosage forms often present limitations such as swallowing difficulties, delayed onset of action, and reduced patient compliance. Orally disintegrating dosage forms (ODDFs) have emerged as a suitable alternative to overcome these challenges. These formulations rapidly disintegrate in the oral cavity without the need for water, making them particularly beneficial for pediatric, geriatric, and epileptic patients. This article reviews the concept and significance of ODDFs in epilepsy management. It focuses on formulation considerations, selection of excipients, methods of preparation, and evaluation parameters associated with ODDFs. The advantages of ODDFs in terms of ease of administration, patient acceptability, and improved therapeutic performance are also discussed. Furthermore, it highlights recent case studies involving antiepileptic drugs, demonstrating the therapeutic potential of ODDFs. The article emphasizes the potential of orally disintegrating dosage forms as an effective drug delivery approach to enhance treatment outcomes and patient compliance in epilepsy therapy.

Keywords

epilepsy orally disintegrating dosage forms orally disintegrating tablets orally disintegrating films superdisintegrants hydrophilic polymers patient compliance

Introduction

Neurological disorders such as Alzheimer’s, Parkinsons, Epilepsy, and Dementia significantly influence global health as they not only affect the quality of life but also hinder cognition and other social aspects. Epilepsy is one such debilitating condition affecting patients world-wide irrespective of age, sex, and nationality. According to the International League Against Epilepsy (ILAE), epilepsy is defined as “Disorder of the brain characterized by an enduring predisposition to generate epileptic seizures, and by the neurobiologic, cognitive, psychological and social consequences of these conditions”.^1,2 Roughly 10-20% of the global population is affected by this condition, with many more still undiagnosed.^2–4 Accurate diagnosis often classifies epilepsy based on the severity and nature of symptoms as represented in Figure 1.

Figure 1.

Classification and stages of epilepsy.

Epilepsy also referred as epileptic seizures arise from a hypersynchronous (excessive) barrage & displacement of neuronal activities in the human brain. These abnormal activities could be due to hypoxic conditions, infection, mental trauma, brain malformations, etc.^3,4 Genetic factors such as family history of epilepsy, genetic mutations, certain other syndromes may also be the underlying cause. Several neurotransmitters such as Serotonin, Glutamate, Dopamine, Gamma-Amino Butyric Acid (GABA), and Noradrenaline are significantly involved in epileptic condition of which GABA plays a key role. GABA generates presynaptic potentials by hyperpolarizing neuronal membranes, thus reducing neuronal excitability in an individual. GABA is also responsible for excitation and inhibition of neuronal networks. Impairment or decrease in GABAergic activity can increase the risk of epilepsy. GAT-1 is responsible for the re-uptake of GABA from the synapses. Any sort of mutation in this GABA transporter could cause myoclonic, atonic seizures.^5–7

An anti-epileptic drug should ideally control epileptic seizures, be well tolerated and have good long term stability. The first line of therapy for Epilepsy includes drugs such as Levetiracetam, Carbamazepine, Clobazam, Topiramate, and Valproate delivered either orally or intravenously for long-term or maintenance therapy. Emergencies necessitate administration of intravenous Phenytoin, Benzodiazepines such as Lorazepam, Diazepam, or Ivermectin.^8–11 Table 1 illustrates the current therapy regimen followed for Epilepsy.

Table 1.

Brief account for drugs used for antiepileptic therapy^1,12–16.

Name of the drug	MOA (just give in a single line)	Drug used for which type of seizure	Type of formulation (IR/SR/ER tablet, or syrup or IV IM formulation
Carbamazepine	Blocks voltage-gated sodium channels	Focal seizures, generalized tonic-clonic seizures	IR/ER tablets, capsules^12,13
Sodium valproate	Increases GABA levels and blocks sodium channels	Broad spectrum: Absence, myoclonic, tonic-clonic, focal	IR/SR tablets, syrup, IV^12,14
Levetiracetam	Binds to SV2A to reduce neurotransmitter release	Focal, generalized tonic-clonic, myoclonic	IR/SR tablets, oral solution, IV¹¹
Lamotrigine	Inhibits sodium channels & glutamate release	Focal, generalized tonic-clonic, absence	IR/SR tablets, oral solution, IV¹²
Benzodiazepines (Lorazepam, Diazepam,Midazolam)	Enhances GABA-A receptor activity	Emergency seizures, status epilepticus, acute seizures	IV(Lorazepam, diazepam), IM (midazolam), Buccal/Intranasal (midazolam), Rectal gel (Diazepam)^12,15,16
Valproate IV	Increases GABA & inhibits sodium channels	Status epilepticus (second-line)	IV^12,16,17

Challenges associated with current antiepileptic therapy

Despite the availability of multiple antiepileptic drugs, effective long-term seizure control remains a challenge for many patients, primarily due to limitation associated with conventional oral dosage forms.^18–20 Swallowing difficulty (dysphagia) is common in pediatric, geriatric, and neurologically impaired populations often resulting in poor compliance or missed doses, which can precipitate breakthrough seizures.²¹ Many AEDs possess bitter taste and an unpleasant odour, discouraging adherence-especially in children. The need for frequent dosing due to short half-lives and variable pharmacokinetics further exacerbates non-compliance.^18,21 Moreover, during or immediately after a seizure episode, patients may be unconscious, disoriented, or unable to swallow, rendering solid dosage forms impractical. Delayed onset of action with conventional tablets can also be problematic in managing acute seizures or preventing recurrence.¹⁹ In addition, some AEDs exhibit low aqueous solubility and erratic absorption, leading to variable plasma concentrations and suboptimal therapeutic response.¹⁸ Caregiver dependency, particularly in pediatric and cognitively impaired patients, further complicates consistent drug administration.²⁰ Collectively, these challenges highlight the pressing need for alternative delivery systems that offer ease of administration, rapid onset, improved palatability, and enhanced adherence-criteria ideally fulfilled by orally disintegrating formulations.^22,23

Orally disintegrating dosage forms

Orally Disintegrating Dosage Forms (ODDFs) have the property to rapidly disintegrate and/or dissolve promptly on coming in contact with the salivary fluid, thus releasing the actual drug in the oral cavity itself.²⁴ These formulations differ from the conventional oral dosage forms, in that they disintegrate and release the drug in the oral cavity itself as opposed to the disintegration in the GIT.25–27 ODDFs are suitable forms for dysphagic, psychotic, paediatric, and geriatric patients; and could also be beneficial for epileptic patients.^28,29 The ideal properties, advantages, and disadvantages of ODDFs are highlighted in Figure 2. An ODDF usually dissolves in the mouth within a matter of seconds, making it suitable for waterless administration. Orally Disintegrating Tablets (ODT), Orally Disintegrating Films (ODF), Orally Disintegrating Mini Tablets (ODMTs), and Effervescent Orally Disintegrating Systems are the most common types of ODDFs researched upon; however, ODTs and ODFs mostly take precedence.³⁴ ODTs are solid unit dosage forms that quickly disintegrate after coming in contact with the salivary fluid; approximately within 30–60 s. ODFs are thin strips composed mainly of a hydrophilic polymer which dissolve rapidly when placed on the surface of the tongue. While the rapid disintegration of ODTs is attributed to the presence of superdisintegrants or sublimating agents, the swift dissolution of ODFs is owing to its negligible thickness and the presence of hydrophilic polymers.34–36

Figure 2.

Advantages, Disadvantages, and Ideal properties of ODDF^30–33.

Formulation aspects of ODTs and ODFs

An ideal drug candidate for the development of ODDFs must have a small dose to allow maximum loading and a molecular weight less than 500 Da to allow for pre-gastric absorption through the mucosal linings of the oral cavity, acceptable taste, and good stability. The commonly incorporated drug candidates for ODTs and ODFs usually include analgesics, antihypertensives, antihyperlipidemics, anti-inflammatories, and antibiotics.37–40

ODTs are also interchangeably referred to as ‘rapidly disintegrating’, ‘fast disintegrating’, ‘fast dispersing’, ‘fast dissolving’, ‘rapid dissolving’, ‘fast melting’, or ‘orodispersible tablets’.⁴¹ A very important excipient influencing the functionality of ODTs are ‘Superdisintegrants’; which by virtue of their rapid water absorption and extensive swelling ability facilitate disintegration of tablets in a few seconds. Apart from conventional excipients such as Crosspovidone, Croscarmellose sodium, Sodium starch glycolate; recently coprocessed excipients have been used which improve the flow properties and compressibility of the tablet blend, besides facilitating rapid disintegration. Some commonly used coprocessed excipients in ODTs include Ludiflash®, Pharmaburst®, and F-Melt®.42–44 Table 2 depicts the different types of excipients used for the preparation of ODTs with the roles and examples of each.

Table 2.

Excipients used in ODTs.

Ingredient type	Example	Role	Ref.
Superdisintegrant	Crosspovidone, croscarmellose sodium, sodium starch glycolate, sodium carboxymethyl cellulose, microcrystalline cellulose, spray dried lactose, alginic acid, sodium alginate, isphagula husk pregelatinized starch, modified corn starch, ion exchange resins, gas evolving disintegrants	Facilitate rapid wicking and swelling of water in tablet core	⁴⁵
Volatile ingredients	Camphor, ammonium carbonate	Used in sublimation method to form a rapidly disintegrating porous matrix	⁴⁵
Sweetener	Sodium saccharin, sugar alcohols, natural sugars (sugar, dextrose, fructose), sugars derivatives, aspartame, vanilla, bubble gum, grapefruit	Masks the bitter and unpleasant taste of the API and improves patient acceptability of the formulation	⁴⁶
Flavor	Peppermint flavor, clove oil, bay oil, anise oil, eucalyptus oil, thyme oil, oil of bitter almonds, vanilla, citrus oils, fruit essences		⁴⁶
Bulking material	Sugar and sugar-based derivatives (dextrose, fructose, isomalt, lactilol, maltitol, maltose, mannitol, sorbitol, starch hydrolysate, polydextrose, and xylitol)	Improves the disintegration and compressibility properties of the API	⁴⁰
Emulsifier	Alkyl sulfates, propylene glycol, lecithin, sucrose esters, sodium dodecylsulfate, sodium lauryl sulfate, polyoxyethylene sorbitan fatty acid esters (Tweens)	May accelerate disintegration of the tablet, some emulsifiers also aid the bioavailability enhancement of poorly absorbed drugs	⁴⁷

Manufacturing methods for ODTs

Methods used for manufacturing ODTs are classified as traditional methods that include direct compression and some newer patented techniques such as lyophilization and cotton-candy process.^48,49 The various manufacturing methods for ODTs, along with their protocol and examples, are summarized in Table 3.

Table 3.

Manufacturing methods for ODTs.

Name of the method	Principle	References
Conventional methods
Moulding	Drug mixed with sweeteners is shaped by gentle heating or pressing, then dried to form tablets.	⁵⁰
Mass Extrusion	Powder softened with solvents, extruded as a gel, dried, crushed into granules, then compressed.	⁵¹
Spray - drying	Liquid drug sprayed into hot air forming porous particles, which are dried, mixed, and compressed. The porosity of the particles aids rapid disintegration.	⁵²
Sublimation	Volatile ingredients such as camphor and ammonium bicarbonate are mixed with excipients are compressed into tablets, then removed by sublimation, leaving behind a porous matrix	⁵³
Wet granulation	Liquid binder added to powder-forming granules, followed by drying and compression. The resultant granules have excellent flow, compressibility, and yield tablets with a short disintegration time	⁵⁴
Direct compression	Powder blend directly compressed into tablets with minimal processing using coprocessed excipients that enhance the flow properties of the tablet blend and accelerate disintegration in the resultant tablets	⁵⁵
Patented technologies
Cotton candy process	Polysaccharides are flash melted and spun to create a ‘candy-floss’ type low-density, porous matrix, milled, blended with drug, then compressed. Enables taste-masking and also suitable for high dose formulations	⁵⁶
Lyophilization	Drug solution frozen and dried under vacuum at low temperature to form lightweight, porous tablets	⁵⁷

Evaluation of ODTs

Evaluation of ODTs primarily involve the assessment of pre-compression and post-compression parameters. Pre-compression parameters assessed for ODTs involve the determination of bulk density, tapped density, and angle of repose. These parameters are particularly important for ODTs manufactured by direct compression method, since they are related to the compressibility and flow-properties of the tablet blend.^58,59

Post-compression parameters involve the usual pharmacopoeial tests performed for tablets such as dimensions, weight variation, hardness, friability, and disintegration time. Of these friability and weight variation are very crucial; since the former evaluates if the tablet is robust enough to mechanical stresses associated with shipping and transportation and the latter determines if the tablet adheres to the pharmacopoeial requirement of an ODT. Besides these, water absorption test and wetting time test may also be performed that confirms the rapid water absorption and swelling of the tablet, which is a prerequisite for faster disintegration.60–62

Orally Disintegrating Films (ODFs)

ODFs are hydrophilic polymeric films that rapidly dissolve in the oral cavity on coming in contact with saliva. They are alternatively also referred to as oral films, oral strips, oral wafers, orodispersible films, orosoluble films, dissofilm, buccal soluble film, and transmucosal film. They usually extend over an area of 5 to 20 cm². Table 4 highlights the excipients incorporated in ODFs alongwith their applications.^63,64

Table 4.

Excipients used in ODFs⁴².

Type of excipient	Example	Role
Hydrophilic polymer	Starch, pullulan, pectin, polyvinyl pyrrolidone (PVP), polyvinyl alcohol (PVA), hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), and Poly (ε-caprolactone) (PCL)	Responsible for the structure of the film, the hydrophilic nature of the polymer promotes absorption of water in the oral cavity and rapid dissolution of the film
Plasticizer	Glycerol, low molecular weight grades of PEGs, phthalate derivatives, citrate derivatives, Triacetin, and castor oil	Enhances the flexibility and lowers the brittleness of the film
Sweetening/Flavoring agents	Saccharin, sucralose, cyclamate, Acesulfame-K, and aspartame	Improve palatability and patient compliance
Saliva stimulating agent	Maleic acid, ascorbic acid, lactic acid	Increases the ingress of water in the film, thereby promoting rapid dissolution

Manufacturing methods for ODFs

ODFs are commonly manufactured using methods like ‘Solvent casting’, ‘Hot melt extrusion (HME)’, ‘Solid dispersion extrusion’, ‘Rolling method’, etc. Of these, solvent casting and HME are more commonly preferred. Table 5 focuses on some of these methods.

Table 5.

Manufacturing methods for ODFs.⁶².

Name of the method	Principle
Solvent casting	The drug, polymers, and other excipients are dissolved in a common solvent. The solution is then spread over a large surface from where the solvent is gradually evaporated.
Hot melt extrusion	The mixture of drug, polymers and other excipients is mixed, melted at an elevated temperature and extruded through a die to form a thin film.
Rolling method	The solution of drug and polymers is loaded on a roller drum, rolled, and dried to form a film,
3D printing	Uses a fused deposition modelling printer
Electrospinning	The drug and polymer solution is electrospun

A few other patented technologies used for the manufacturing of ODFs include Pharmfilm^®, VersaFilm^TM, Thinsol^TM, SmartFilm^®, BEMA^®. ODFs are often evaluated in terms of thickness, content uniformity, tensile strength, percent elongation, degree of swelling, and more significantly the wetting time and disintegration time.

Applications of ODDFs for the treatment of epilepsy

ODDFs represent a significant breakthrough in the patient-friendly approach of drug delivery. This approach can be particularly beneficial for the administration of antiepileptic drugs. Epilepsy management demands accurate dosing, rapid onset of action, and sustained patient adherence—requirements that are often hindered by the conventional oral dosage forms used for the delivery of antiepileptic drugs as stated in Table 1. Epileptic patients often experience dysphagia, cognitive impairment, or postictal confusion, all of which compromise effective oral administration and clinical outcomes.^58,59 ODTs which disintegrate rapidly upon contact with saliva obviating the need for water, overcome these challenges by facilitating ease of administration and ensuring accurate dosing even for a non-cooperative patient. Moreover, the rapid disintegration and dissolution of the drugs enable rapid absorption and a faster onset of therapeutic action, which is particularly desirable in preventing seizure recurrence. Improved palatability, portability, and better patient-compliance further boost their therapeutic utility across pediatric, geriatric, and neurologically compromised populations. Thus, ODDFs offer a practical and efficacious platform for antiepileptic drug delivery, corroborating pharmacokinetic performance with the real-time needs of patients and caregivers while achieving better therapeutic outcomes.⁶⁵ The following section highlights some of the case studies that demonstrate the development of ODDFs, for the delivery of antiepileptic drugs and the benefits offered by the ODT formulation compared to the conventional ones.

Development of ODDFs for the delivery of antiepileptic drugs

Stiripentol (STP) is the drug of choice for the treatment of ‘Dravet Syndrome’, which is a severe myoclonic epilepsy occurring in infants. It is classified as a resistant childhood epilepsy that is frequently not adequately treated with first-line antiepileptic drugs. STP is a poorly water-soluble drug with low and variable bioavailability that hinders its clinical efficacy. Moreover, STP is formulated as orally administered reconstitutable powders that may be difficult for pediatric patients to swallow. Hence the need to develop an easy to swallow and rapid acting formulation for STP. Affi (2014) incorporated STP in ‘Fast-Dissolving Tablets (FDTs)’ using different concentrations of sodium starch glycol (SSG) and croscarmellose sodium (CCS) as superdisintegrants using direct compression. The effect of the concentration of superdisintegrants on the disintegration time for the formulation was studied and it was found that the formulation containing the highest concentration of SSG (6.6%) and CCS (15%) in combination had the shortest disintegration time (21 s) and the fastest wetting time (22.3 s). The disintegration test was performed in distilled water at 37 ± 2°C using a standard disintegration apparatus, and the wetting time was determined by placing the tablet on tissue paper soaked with 0.5% eosin dye solution until the upper surface was completely wet. The in vitro dissolution study revealed that this formulation achieved nearly complete drug release (99.89%) within just 15 min in 900 mL of phosphate buffer (pH 6.8) containing 0.25% sodium lauryl sulfate (SLS) using the USP Type II dissolution apparatus at 50 rpm. Thus, compared to the conventional tablet lacking superdisintegrants, which released only 41.2% of the drug within the same period, the optimized formulation containing SSG and CCS demonstrated markedly enhanced dissolution and drug availability, confirming the synergistic action of these superdisintegrants in promoting rapid disintegration and efficient drug release.⁶⁶

Another compelling case study published by Patel et al. (2024) demonstrates the development of a Pregabalin loaded ODF to address the difficulties associated with delivery of Pregabalin for the treatment of paediatric epilepsy. By avoiding first-pass metabolism, achieving rapid drug release, and masking the natural bitterness of the drug, the researchers hoped to improve patient compliance and clinical outcomes. A solid dispersion of pregabalin with β-Cyclodextrin in a 1:2 ratio was first made using the kneading method to improve the solubility and effectively mask the bitter taste of the drug. The solid dispersion was then loaded in the ODF by solvent casting method. The concentration of the hydrophilic film-forming polymer (HPMC E15) and plasticizer (glycerol anhydrous) were found to be crucial determinants of tensile strength, disintegration time, and drug release in a 3² full factorial design used to optimise the film. The case-study also demonstrated the effectiveness of a Quality by Design (QbD) approach in developing a stable, patient-centric, and fast-acting ODF for antiepileptic drugs. The optimised film incorporating 3% w/v of HPMC E15 and 15% v/v of glycerol anhydrous, along with the solid dispersion containing Pregabalin:β-Cyclodextrin (1:2), demonstrated excellent properties, including a rapid disintegration time of 25 s and a rapid drug release of over 90% within 6 min in comparison to a conventional marketed pregabalin tablet that released only about 60% in the same time-frame. Palatability tests confirmed successful taste masking, and stability studies showed no significant changes the film’s critical attributes over 3 months under accelerated conditions.⁶⁷ Stability studies conducted at 40°C ± 2°C/75% ± 5 % RH for 3 months showed no significant changes in tensile strength, disintegration time, or cumulative drug release, confirming the formulation’s stability. Palatability tests confirmed successful taste masking and high acceptability.

In another study, Lacosamide was used as a model antiepileptic drug which when administered orally gave results as 100% bioavailability by in vivo drug release. It shows its mechanism of action by inactivation of voltage gate Na + channels thereby reducing the hyperactivity of brain cells, and exercising effective control in epilepsy. FDTs of Lacosamide were prepared using Guar Gum as a natural superdisintegrant and Microcrystalline cellulose (MCC) was used as a binder/filler in comparative synthetic formulation. The tablets were manufactured by Direct compression method. The optimized batch of compressed tablets containing 5% Guar Gum was found to rapidly disintegrate within 28 s. The wetting time of the formulation was merely 3.48 s, while it absorbed 60% water. The formulation achieved almost complete release within 12 min in a pH 6.8 phosphate buffer. Thus, the developed Lacosamide FDT offered a better alternative than the conventional formulations for the treatment of pediatric epilepsy.⁶⁸

Lamotrigine is another antiepileptic drug that is used for pediatric epilepsy. However, the poor water-solubility of the drug restricts a rapid onset of action which is indispensable to epilepsy management. Lamotrigine was coformulated with polyvinylpyrrolidone to form an amorphous solid dispersion which was then mixed with different proportions of superdisintegrants to develop fast-dissolving tablets by direct compression. The optimized formulation containing a higher proportion of Crospovidone disintegrated within 52 s with a wetting time of 18 s. The formulation released almost 92% of the drug within 30 min⁶⁹

A study published by Boudria et al. concerns use of a three-dimensional (3D) printed fast-melt formulation of Levetiracetam (LEV) to improve convenience and bioavailability while maintaining pharmacokinetic equivalence to standard tablets. The 3D printing method generated almost porous tablets that were then compared to the conventional immediate-release tablet under fasted and fed conditions in healthy human volunteers. While the fast-melt tablets showed an almost 1.2 times increase in the Cmax compared to the conventional tablets in both fed and fasted conditions., the Tmax, AUC, and t1/2 of both the formulations were almost identical. However, the fast-melt tablet disintegrated in less than 10 s, that of the conventional tablet was almost 3 min.

Furthermore, 3D printing enabled precise dose uniformity and a customised tablet structure. Drug stability was also preserved in the absence of high-temperature and high-stress manufacturing steps like drying and compression. 3D printing thus offered an innovative approach to produce fast-melting levetiracetam tablets that perform equivalently to conventional tablets in the body, combining precise manufacturing with effective therapeutic outcomes.⁷⁰

Kandilli et al. developed ODTs of a combination of Carbamazepine and Levetiracetam for pediatric patients freeze-drying (lyophilization) and direct compression methods. The comparative antiepileptic effect of the individual drugs, their combination, and the ODT formulations were evaluated in the rats with pentylenetetrazole (PTZ)-induced epilepsy model. The ODTs prepared by both the methods had optimum hardness, friability values less than 1% and rapid disintegration times. Compared to the seizure scores obtained for groups treated with the individual drugs or combination of drugs, the score obtained for the group treated with ODT was significantly lower. Thus the ODT formulation not only offered a patient compliant approach of combination drug delivery, but also enabled a better therapeutic outcome.⁵²

The earlier sections emphasise on the importance of coprocessed excipients to develop a tablet blend suitable for direct compression as well as achieving the rapid release typical to ODTs. Teaima et al. explored the effect of different coprocessed excipients on the flow properties, compressibility, and disintegration time of the resultant ODTs. Antiepileptic drug, Leviteracetam was used as the model drug and coprocessed excipients such as Pharmaburst® 500, F-melt® type C, Prosolv® ODT, Prosolv® EasyTab SP, Prosolv® HD90 Prosolv®, EasyTab Nutra, Spress® B820 were investigated by direct compression method. The lowest wetting time and fastest disintegration time was found in the tablets compressed with Pharmaburst® 500 which is a combination of spray-dried mannitol and sorbitol, along with crospovidone and, in some formulations, colloidal silicon dioxide. The presence of crospovidone and mannitol, besides the porous nature of the particles obtained by spray-drying may have been responsible for the rapid wetting and disintegration of the tablets. The tablet released almost 99% of the drug within 10 min. In vivo pharmacokinetic studies performed in male Wistar rats showed a 3x increase in the Cmax and a 4x increase in AUC for the ODT formulation compared to an oral solution of the drugs.⁷¹ This concludes the ability of the ODTs incorporating coprocessed excipients to enhance the bioavailability of the drugs significantly.

Conclusion

Orally disintegrating dosage forms have emerged as a promising alternative to conventional oral dosage forms for the effective management of epilepsy. Their rapid disintegration, ease of administration without water, and improved patient acceptability make them particularly suitable for pediatric, geriatric, and dysphagic patients. This review comprehensively discusses formulation strategies, excipient selection, manufacturing techniques, and evaluation parameters essential for the development of orally disintegrating tablets and films for antiepileptic therapy. The case studies included in this review further demonstrate the practical applicability of orally disintegrating dosage forms, highlighting improvements in disintegration time, dissolution behavior, and overall formulation performance when compared with conventional systems. These studies provide supportive evidence for the feasibility and therapeutic relevance of such dosage forms in epilepsy management. Although challenges such as taste masking, dose uniformity, and stability remain, continuous advancements in formulation technology and excipient engineering are addressing these limitations. Overall, orally disintegrating dosage forms offer a robust and patient-centric drug delivery platform and hold considerable potential for enhancing treatment outcomes and quality of life in patients with epilepsy, supporting their expanded development and future clinical application.

Footnotes

ORCID iDs

Vanitha Mudhalayar

Yash Bari

Dhruv Bhanushali

Aradhya Gavali

Tanmay Patil

Manasi Chogale

Author contributions

Vanitha Mudhalayar and Yash Bari: Conceptualization of the idea, literature survey, writing the manuscript

Dhruv Bhanushali, Aradhya Gavali, and Tanmay Patil: Literature survey, manuscript writing, proofing

Manasi Chogale: Conceptualization of the idea, manuscript checking, and proof-reading

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Author biographies

Vanitha Mani Mudhalayar is a final-year Bachelor of Pharmacy student (2022–2026) at Saraswathi Vidya Bhavan’s College of Pharmacy, University of Mumbai with interest in Pharmaceutics and Pharmacology.

Yash Chandrakant Bari is a final-year Bachelor of Pharmacy student (2022–2026) at Saraswathi Vidya Bhavan’s College of Pharmacy, University of Mumbai. His research interests include formulation development, QA/QC, and AI in pharmaceutical sciences.

Dhruv Bhanushali is a final-year student at Saraswathi Vidya Bhavan's College of Pharmacy, pursuing a Bachelor’s degree in Pharmacy. His interests include Quality Assurance (QA), Quality Control (QC), healthcare, and pharmaceutical sciences.

Aradhya Gavali is a final-year Bachelor of Pharmacy student at Saraswathi Vidya Bhavan's College of Pharmacy with interests in pharmaceutical sciences, industrial pharmacy, business, and marketing.

Tanmay Patil is a final-year Bachelor of Pharmacy student at Saraswathi Vidya Bhavan’s College of Pharmacy. His interests include pharmaceutical sciences, management, leadership, research, and professional growth.

Dr. Manasi Chogale pursued her Ph.D. in Pharmaceutics from the Institute of Chemical Technology, Matunga, Mumbai and is an Assistant Professor in the Department of Pharmaceutics at Saraswathi Vidya Bhavan’s College of Pharmacy. Her research interests include formulation development and nano drug delivery systems.

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