1. INTRODUCTION:

Hypertension is a risk factor for numerous illnesses, including heart attack, renal failure, and stroke¹. Heart tissue can be severely damaged by hypertension, arterial calcification can occur as a result of excessive pressure, leading to decreased circulation of blood and oxygen to the heart. Enhanced blood pressure can result in chest discomfort (Hypertension Stage1) often known as angina. Every year, about 10 million people lose their lives because of hypertension, and around 1.3 billions affected³. Anti-hypertensive drugs are frequently used to treat hypertension.

Medication for hypertension comes in a wide variety of forms. Since the majority of anti-hypertensive medications undergo first-pass metabolism, their oral bio-availability is typically less (20–50%). So, it can be hard to make sure that anti-hypertensive medicines are used correctly¹ and patient compliance must also be taken into consideration⁴. In such types of situations, Mouth Dissolving Films (MDFs) provides a practical way of administering drugs to both the general public and certain demographic groups with swallowing challenges, such as the elderly⁵. MDFs are well-accepted oral administration for a variety of medications, including analgesics, neuroleptics, cardiovascular therapies, etc. It is the modern drug delivery technology which delivers a highly practical way to take prescribed medications and dietary supplements⁶. MDFs are as thin as postage stamps and contain an active substance or medical excipients. These dosage forms can be applied on the tongue Without drinking water or chewing, MDFs disintegrates instantly or within a few seconds and releases drugs that dissolve or spread in saliva⁷. These also benefit from having a high surface area for quick disintegration and are thus user-friendly, researchers have expressed interest to develop MDFs, since these are easy to administer, and their preparation, handling, transportation, palatability, and dosage consistency makes them the formulation of choice⁸. The careful selection of included excipients for making MDFs is crucial, as they must rapidly disintegrate and dissolve in the mouth⁹. This review will focus on the preparation methods, evaluation, characterization of MDFs and their role to deliver anti-hypertensive drugs.

2. Formulation of MDFs:

2.1 Choice of Active Pharmaceutical Ingredient (API):

The pharmaceutically active substances such as captopril, telmisartan, atenolol, etc. which could be delivered orally or via buccal mucosa can be served as active ingredient. API may be added to polymers in amounts ranging from 1 to 25% by weight¹⁰.

2.2 Film-forming polymers:

Polymers have been used in various distribution systems¹¹. Several polymers like chitosan, hydroxy Propyl methylcellulose (HPMC), Poly vinyl alcohol (PVA), etc. can be used to create MDFs. In medical and nutraceutical applications, the use of film-forming polymers in oral films has drawn significant interest¹². The polymers can be mixed or utilized individually to achieve the desired film properties.

2.3 Plasticizers:

Plasticizers can be added to formulations to enhance their mechanical properties (tensile strength and elongation). Plasticizers like polyethylene glycol and glycerol are frequently used in MDFs¹³.

2.4 Flavoring Agents:

To make dosage forms more palatable and to promote patient compliance, flavoring compounds like vanilla, coffee, cocoa, chocolate, citrus,etc. are frequently utilized in the formulation process. As it masks the bitterness, these are also known as taste-masking agents¹⁴.

2.5 Sweetening agents:

Sweeteners have become essential elements in the composition of food and pharmaceutical products that are intended to dissolve or disintegrate in the oral cavity. Both natural and synthetic sweeteners (Aspartate, Sorbitol, Sucrose, Mannitol, etc) can be employed in the formulation¹⁵.

2.6 Coloring Agents:

Coloring agents such as titanium dioxide are being used to improve the appearance of pharmaceutical formulations¹⁶.

2.7 Surfactants:

Substances like Tween 80 and Sodium Lauryl Sulfate are utilized as solubilizing and wetting agents to quickly dissolve the film¹⁷.

2.8. Stabilizing agents and Thickening agents:

The stabilizing and thickening agents like locust bean gum, xanthan gum and cellulose substitutes can be employed¹⁸.

3. Methods for the Preparation of MDFs:

3.1 Solvent casting method:

This procedure includes the dispersion of the drug and other excipients in a suitable solvent, together with the dissolution of the water-soluble polymers in the same solvent (Fig. 1). Subsequently, the two solutions are amalgamated in a beaker and agitated using a magnetic stirrer to generate a uniform solution. Finally, mixture is casted into the petri dish, dried at the proper temperature, and sliced into uniform dimensions⁶.

3.2 Semisolid casting:

The semisolid casting technique commences by preparing a solution of water soluble polymer that can produce a film. A solution of ammonium or sodium hydroxide containing a polymer that is insoluble in acid (such as cellulose acetate phthalate or cellulose acetate butyrate) is introduced to the resulting solution. After adding the necessary amount of plasticizer, a gelatinous material is formed which is molded into the films or strips employing heat-controlled drums¹⁹.

Fig. 1 Solvent casting method

3.3 Rolling Method:

This method includes rolling a drug-containing solution or suspension onto a carrier. As a solvent, water or alcohol is employed. The film is cured on the rollers until being shaped and sized as needed²⁰.

3.4 Hot melt extrusion:

In HME (Fig. 2), a medication is formulated with one or more additives including polymers and plasticizers, that have the ability to melt and often lead to the formation of solid drug dispersion in the polymer. After cooling, molten material is extruded. It has many benefits, including the potential to increase medication bio-availability, the lack of a need for solvents, and ease of scaling up and industrial use ²¹.

3.5. Solid dispersion extrusion:

"Solid dispersions" refers to solid-state dispersion of one or more active substances with amorphous hydrophilic polymers in a chemically inactive carrier. An appropriate liquid solvent is employed to dissolve the medicine. Once the solution has been heated to a temperature exceeding 70 °C, it is then added to liquid polyethylene glycol. Using dies, the solid dispersions are finally molded into the films²².

4 . Evaluation of MDFs^8,15,23

4.1 Weight variation of films:

It can be investigated by estimating the average weight after weighing each of the 10 films that were chosen at random. Higher variation in weight indicates inefficiency of the method used and non-uniformity of drug content.

4.2 Thickness:

At several, key spots, it may be measured using a calibrated digital Vernier caliper or a micrometer screw gauge. It is essential to ascertain uniformity in film’s thickness as this is directly linked to accuracy of dose.

4.3 Tensile Strength:

The maximum stress that may be exerted on a strip specimen before it breaks is referred to as its tensile strength. The evaluation is accomplished by dividing the applied load at rupture by the cross-sectional area of the strip.

4.4 Percent elongation:

Strain is essentially the strip's deformation divided by the sample's initial dimension.

Increse in length

Percent elongation = --------------------------- x 100

Original length

4.5 Young’s modulus:

It is a gauge for strip stiffness. In the zone of elastic deformation, it is measured as the ratio of applied stress to strain:

Young’s modulus =

Force at corresponding strain 1

= ---------------------------------- x ------------------------

Cross –sectional area Corresponding strain

Hard and brittle film demonstrates a high tensile strength and Young's modulus with small elongation.

4.6 Tear resistance:

Overall resistance of a film to rupture affects how resistant it is to tear. The tear resistance value is expressed in Newtons and represents the maximal stress or force necessary to rupture the specimen.

4.7 Folding endurance:

The strip is folded repeatedly to test folding endurance. The folding endurance score is determined by the film's ability to withstand 300 times folds without any breakage.

4.8 Swelling property:

Film swelling is conducted utilizing a simulated saliva solution. Prior to assignment every film sample is weighed and then placed into a pre-weighed stainless steel wire mesh. which is then dipped into 15 ml medium in a plastic container. At certain time intervals, the weight of the film increased until a steady weight has been noticed.

4.9 Assay/ content uniformity:

Any standard test technique specified for the specific API in any of the standard Pharmacopoeia is used to ascertain this. By measuring the API content in each strip, content consistency can be assessed. As per IP, the limit of content uniformity is 85-115%.

4.10 Disintegration time:

MDFs must be disintegrated using disintegration equipment.MDFs strips are subjected to the same disintegration time constraint of 30 seconds or less for orally disintegrating films as per standards.

4.11 Dissolution test:

The conventional basket or paddle equipment can be used to perform dissolution tests.

5. Role of Mdfs for The Delivery of Antihypertensive Drugs:

5.1 Captopril, an ACE inhibitor, functions by inducing vasodilation, so facilitating improved blood flow via the blood arteries. Oral disintegrating tablets of captopril have the advantage of being able to be administered without the risk of choking, and they disintegrate quickly. After disintegration materials contained in them are insoluble, and they remain until they are swallowed. In such circumstances, the development of a film that dissolves quickly will be beneficial. Abdelkader et al. (2023) formulated polyvinyl alcohol, sodium alginate, gelatin-based oral dispersible films loaded with captopril for pediatric hypertension. The optimized films indicated significant enhancement in bioavailability i.e.1.43 times that of commercial tablets^.24Naik et al. (2022) developed the formulation of captopril MDF by using the solvent casting process. Based on in vitro dispersion time, formulations with 4% crospovidone were found to have a promising dispersion duration of 7 to 10 seconds²⁵. Demchuk et al. (2022) also developed fast-dissolving films containing captopril The parameters including mass uniformity, thickness, swelling index, tensile strength, elongation, and disintegration time are all taken into account²⁶. Ishwarya et al. (2022) created captopril MDFs by solvent casting method. Based on the results, film containing HPMC E15 and HPMC K4M were preferable for the formulation of film which have greater drug release rate and in vitro disintegration time of 52 seconds. According to evidences from various studies MDFs showed good results to manage hypertension²⁷.

5.2 Telmisartan, a BCS class II anti-hypertensive, has a poor solubility profile and limited oral bio-availability, which makes it difficult to dissolve. But telmisartan requires rapid absorption for an immediate start to the action. Devi and Kumar (2024) developed telmisartan loaded fast dissolving films using Mango kernel, maltodextrin and propylene glycol. The optimized films were found to have the greatest bioadhesive strength of 49.82 gm with ex-vivo mucoadhesion of 189 min. In vitro studies indicated more than 60% of drug release within 10 min.²⁸ Husain et al. (2022) created MDF with increased telmisartan solubility. Films were created using the solvent casting technique. For quick hydration of the film, HPMC E15 as a film-forming polymer was utilized. The faster disintegration was achieved by using sodium starch glycolate as a super disintegrant²⁹.

5.3 Amlodipine, is a BCS class I oral hypertensive drug that is often given to people with severe high blood pressure. Because high blood pressure needs to go down quickly, it is important to design drug delivery systems that can get the drug into the systemic circulation in a short amount of time. Kumar et al. (2022) created MDF carrying amlodipine by employing xanthan gum, a natural polymer, to produce the film. The MDFs were created using the solvent-casting process. To create the films, a 3²-factorial method was utilized. The study findings were able to justify the usage of films for quick drug release. Additionally, it was discovered that the formulations may virtually completely discharge the drug in 10 min. The accelerated stability study findings showed that all of the developed film batches were stable at storage³⁰.

5.4 Azelnidipine, is a BCS class II drug that is used to treat high blood pressure. Since azelnidipine doesn't mix well with water, not well absorbed by the body, and takes a long time for absorption. Wankhede et al.(2021) created an Azelnidipine MDF that would dissolve quickly. Utilizing the idea of mixed hydrotropic, fast-dissolving films can offer rapid action. To prepare a solid dispersion of azelnidipine utilizing optimal combination, distilled water was used as the solvent. A safe and affordable method for increasing the bio-availability of weakly water-soluble medicines is solid dispersion. The physical attributes of the produced films, including weight variation, surface pH, drug concentration, flexibility, disintegration time, dissolution time, and in vitro dissolution tests, were evaluated which showed increased solubility and bio-availability of azelnidipine ³¹.

5.5 Atenolol is a drug that is used to treat high blood pressure. It is a relatively polar hydrophilic compound that dissolves in water at a rate of 26.5 mg/mL. Because of the first-pass effect, about 45–55% of atenolol is bioavailable when taken in tablet form. Rani et al. (2021) created MDF of atenolol to improve convenience and adherence for individuals with hypertension. The FTIR spectrum and the molecular docking results both validated the hydrogen bonding between atenolol and the film formers. The results of this investigation indicate that HPMC E5 is the best film former for atenolol MDFs³², Satpute et al. also formulated MDFs to achieve quick disintegration with better bio-availability through the oral route. The optimized batch has shown no significant change in dissolution profile throughout the accelerated stability testing. No chemical interactions between the medication and polymer were detected in the formulation by FTIR and DSC. This results concluded that MDFs of atenolol may be a better option than tablets and capsules for achieving quick oral absorption³³.

5.6 Ramipril, is an angiotensin-converting enzyme (ACE) inhibitor. It is a BCS class II drug that is hard to dissolve and goes through a process called first-pass metabolism, which decreases its bioavailability by 28%. Nirmala et al. (2020) created ramipril MDFs. Ramipril's solubility was improved by creating an inclusion complex with cyclodextrin in three ratios (1:0.5, 1:1, and 1:2). A total of 12 ramipril MDF formulations were created using different polymers and their physicochemical properties were assessed. To achieve optimum drug release and a fast commencement of an action, the formulation had a minimum disintegration time of 9 seconds was selected for further evaluation. According to the study, ramipril MDF has a faster onset of action and greater therapeutic efficacy than commercially available medication³⁴.

5.7 Sacubitril, sodium is a neprilysin inhibitor that is used to treat high blood pressure. But Sacubitril sodium required faster release. Shaik et al. (2020) created the MDF of Sacubitril sodium. The physical attributes of the produced films, including weight variation, surface pH, drug concentration, flexibility, disintegration time, dissolution time, and in vitro dissolution tests, were assessed. The findings indicated that films possess a reduced propensity to irritate the oral mucosa, hence promoting comfort. It was determined from the results of the study that these films offer a promising method of oral medication administration for quick drug release for the management of hypertension³⁵.

5.8 Chlorthalidone, is a sulphonamide derivative of benzene, specifically a phthalamide. Thiazide diuretics are the established pharmacological treatment for uncomplicated hypertension. However, chlorothalidone has low bioavailability because it undergoes significant first-pass metabolism. To improve bioavailability, therapeutic efficacy, and patient compliance of chlorthalidone, Yelave et al. (2024) formulated buccal films using HPMC. The optimized films indicated good tensile and mucoadhesive strength. The Ex vivo drug permeation studies showed 87.2±0.93% permeation after 8h.³⁶Biyani et al. (2020) performed an effort to fabricate and improve a mouth-dissolving film that is filled with chlorthalidone utilizing solvent evaporation methods. Based on preliminary testing, percentage of HPMC E5 and PEG 400) were chosen as the two separate variables, mannitol as bulking agent and sodium starch glycolate as a disintegrant. The physicochemical characteristics, disintegration rate, and then in vitro drug release studies of these manufactured films were assessed. According to the multilevel conclusory design, the formulation showed better results, with a drug release rate of 98.95%³⁷.

5.9 Losartan potassium, is an angiotensin II receptor antagonist prescribed to treat hypertension. Losartan is well absorbed following oral administration due to its strong first-pass metabolism, but its bioavailability is significantly lowered after oral administration. Sadique and Ramya (2020) prepared losartan potassium loaded fast dissolving films using PVP, HPMC and pectin by solvent casting method. The average folding endurance of films was found to be 112 to 208. The in vitro drug release indicated 78 to 96% within 5 min.³⁸Raza et al. (2019) created losartan potassium loaded MDFs with quick disintegration, ideal morphological characteristics, and mechanical properties for the treatment of hypertension. Anti-hypertensive medication losartan undergoes substantial first-pass metabolism, which lowers the drug's bio-availability. The drug's bio-availability rises since it reaches the bloodstream rapidly through the buccal pathway. The hydrophilic film-forming polymeric foundation included HPMC, sodium carboxymethylcellulose, sodium alginate, and gelatin, while glycerol served as the plasticizer. By using the solvent casting process, films were created. In-vitro release of a drug, swelling index, material homogeneity, folding endurance, and in-vitro disintegration duration were among the criteria assessed. The ratios of the plasticizer and polymer were optimized using a 3²-factorial design. According to in-vitro dissolution experiments, 99% of the potassium in losartan was released in only 5 minutes, with an average disintegration time of 38 seconds³⁹. Various MDFs formulated to manage hypertension have also been depicted in Table 1.

Table 1: Various MDFs formulated to manage hypertension.

Drug	Polymers Used	Method	Remarks	Reference
Fosinopril	HPMC 5cps, PMC E-3, HPMC E-15	Solvent casting method	Good folding endurance, Low disintegration time.	2018⁴⁰
Quinapril	HPMC 50cps, E5, E15.	Solvent evaporation method	Low disintegration time.	2018⁴¹
Atenolol	HPMC E15	Solvent casting method	The formulation has shown less disintegration time.	2017⁴²
Losartan potassium	HMPC 15, HPMC 50cps, PEG.	Solvent casting method	Low disintegration time, Enhanced absorption.	2016⁴³
Enalapril Meleate	HPMC K 15, PVA.	Solvent casting method	Films showed excellent stability when stored in accelerated conditions.	2016⁴⁴
Lisinopril	HPMC E15, PVA	Solvent casting method.	The film disintegrated within eleven seconds which release the drug rapidly.	2015⁴⁵
Bisoprolol Fumarate	HPMC, maltodextrin	Solvent casting method.	Stability of films enhanced.	2015⁴⁶
Lisinopril	HPMC E5 LV, HPMC E 3, HPMC 4KM.	Solvent casting method.	An enhanced rate of drug release was accomplished.	2015⁴⁷

Abbreviations: HPMC: Hydroxy Propyl methylcellulose, PVA: Poly vinyl alcohol, SCMC: Sodium carboxymethyl cellulose.

6. CONCLUSION:

Mouth-dissolving films have the properties like improved patient compliance, increased efficiency, and increased safety as compared to standard oral dosing forms. It is the formulation of choice due to its user-friendliness in terms of administration, preparation (which calls for a low number of excipients, which results in a product that is more cost-effective), handling, transportation, palatability, and dose uniformity. Oral administration is a viable option for this important dosage type, which may be used to treat urgent medical disorders like hypertension as well as other situations in which a rapid impact is desired. As a consequence, MDFs have proven to be as the exceptional future potential as a consequence of the outstanding benefits and patient compliance. Since, MDFs have lots of benefits, the scientist/researches must concentrate on MDFs for the delivery of antihypertensive drugs.

7. DECLARATION OF CONFLICTING INTERESTS:

The authors declare no any conflicts of interest.

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Received on 09.10.2023 Revised on 01.11.2024

Accepted on 08.05.2025 Published on 08.11.2025

Available online from November 13, 2025

Research J. Pharmacy and Technology. 2025;18(11):5605-5611.

DOI: 10.52711/0974-360X.2025.00809

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.

Mouth Dissolving Films:

An Emerging Platform for Anti-Hypertensive Drugs

Chitkara College of Pharmacy, Chitkara University, Punjab, India.