INTRODUCTION:

The oral cavity is a preferred route for administering drugs, especially those not metabolized in the stomach. It has a high blood supply and direct administration into the systemic circulation. The buccal epithelium contains extracellular substances, which contribute to intercellular adhesion, mechanical strength, and barrier to permeability¹. Buccal films are more effective than oral gels and tablets due to extended residence time, comfort, and flexibility². Buccal film is an efficient and effective dosage form, with improved bioavailability due to its skip of presystemic metabolism. It is palatable and acceptable, making it ideal for pediatric and geriatric patients without ingesting medication³.

Alternative routes are needed for drugs with poor skin penetration, water solubility, high molecular weight, and first-pass metabolism susceptibility. Oral routes are growing for most medications, resulting in quicker delivery and improved bioavailability.⁴Buccal films contain polymers, plasticizers, drugs, sweeteners, and water-dispersible polymers for systemic drug delivery^5,6. Antihypertensive drugs are used for treating myocardial infarction (MI) and stroke, two conditions caused by high blood pressure. According to the information that is now available, a 5mmHG reduction in blood pressure can lower the risk of stroke by 34%, ischemic heart disease by 21%, heart disease, memory loss, and cardiovascular disease mortality⁷. To treat hypertension, Irbesartan is a dose dependent antagonist of the angiotensin II (AII) receptor. It has been discovered to be safe and efficient at reducing blood pressure. Its removal will occur in two phases, with a half-life of elimination (t1/2) ranging from around 11 to 15 hours. The medication reaches steady state levels in three days, and after once daily treatment again, minimal accumulation (20%) is observed in plasma⁸. When taken orally, the whole bioavailability ranges from 60 to 80 percent, and the peak concentration in the blood is attained 1.5 to 2 hours later⁹. The purpose of this study is to determine whether quickly dissolving buccal films can be used to administer Irbesartan quickly, with the goal of increasing patient compliance and bioavailability.

MATERIALS AND METHODS:

Irbesartan was obtained from Dr. Reddy's Lab, HPMC E5 from Dow Chemical's Asia, and Polyvinyl Alcohol (PVA) from Yarrow Chemicals Ltd., Propylene Glycol High-pure Fine Chem., and Sodium Saccharin High-pure Fine Chem., respectively.

Estimation of Irbesartan:

The study uses spectrophotometric and chromatographic methods to determine irbesartan in dose and pure form^10-12. Using 6.8 pH phosphate buffer, serial dilutions were carried out, yielding a concentration range of 2–10 µg/ml. Using a Lab India double-beam UV spectrophotometer (UV 3200+ series) and 6.8 pH phosphate buffer as a blank solution, the absorbance of these standard dilutions was determined at λmax of 244 nm. The technique is straightforward, accurate, and sensitive, allowing for accurate estimation of irbesartan in both pure and dosage forms.

Saturated Solubility Studies:

Irbesartan saturated solubility tests were carried out using various dissolving mediums. Irbesartan 500mg was weighed separately and put into an alternative conical flask. Add a specified amount of different dissolution media into the individual conical flasks, close them appropriately, and place them in the REMI orbital incubator shaker at 50 rpm at 37°C for 24 hours^13,14,15. The samples were then filtered when the conical flasks were taken out of the incubator shaker.Following a suitable dilution with a suitable dissolving medium, the resulting solution was used as a blank solution to note the absorbance values at λmax of 244 nm.

Preparation of Irbesartan Fast Dissolving Films:

The solvent casting process was utilised to make buccal films that dissolve quickly with irbesartan^16,17. Aqueous solutions of polyvinyl alcohol (PVA) and hydroxypropyl methylcellulose (HPMC E5) were prepared individually in beakers. HPMC E5 was added to PVA to create a homogenous solution labeled Solution A. Propylene glycol was used to dissolve irbesartan and sodium saccharin, yielding a medication and plasticizer solution known as Solution B. After being cast onto a non-adhesive base plate, the solution was dried for 24 hours under an infrared light. The films were cropped to the proper length. The recipe for Irbesartan buccal films was optimised after a series of experiments. Table 1 lists the ingredients of Irbesartan buccal films, and Figure 1 illustrates how they are made.

Evaluation of Physical Parameters for Irbesartan Fast Dissolving Films:

The films were assessed for visual examination, surface texture, surface area, folding endurance, swelling index, and drug content using tests such as the Franz diffusion cell, with results displayed in Table 2.

Visual inspection:

The oral films properties like homogeneity, color, transparency, and surface were assessed through visual inspection and touch or feel for all prepared buccal films¹⁸.

Weight variation:

Weighing each of the ten buccal films separately and figuring out the average weight allowed us to calculate the weight fluctuation of the film. Acceptable films had weights of no more than two films deviating by 7.5% and no film deviating by more than 15%¹⁹.

Surface area:

The surface area of circular films was measured by measuring their diameter using a scale, and the average radius was calculated using the formula A = πr², where r represents the film's radius¹⁴.

Thickness measurements:

In order to ensure consistency in film thickness and precisely calculate the dosage in the strip, the film thickness was measured with a micrometre screw gauge at five separate points. The data are shown as the mean± standard deviation (SD) from three duplicate determinations²⁰.

Folding endurance test:

One film was folded a maximum of 250 times or until it broke to determine the folding durability of randomly chosen films. The results were reporeted²¹.

Surface pH:

Utilising commercially available pH strips, the surface pH of the fast-dissolving film was tested to assess any potential in vivo adverse effects. Water was used to moisten the film, and a pH test strip placed that came into contact with the oral films surface was used to determine the pH. Each formulation's average of the three determinations was calculated^{22, 23}.

Swelling Index:

Swollen salivary fluid is used to study a film's swelling index. 50 millilitres of stimulated salivary medium are added to the weighted film, which is then enclosed in a reweighed stainless steel wire mesh. Every interval, the weight of the film is ascertained until a steady weight is noted. The following formula is used to determine the extent of swelling²⁴.

SI = W_t – W_o / W_o

Where SI is the swelling index,Wt is the weight of the film at time “t”, andWo is the weight of film at t = 0

Percentage moisture absorption (PMA):

The PMA test evaluated how stable mouth-dissolving films were in extremely humid environments. Three films were kept at 79.5% relative humidity in desiccators filled with an aluminium chloride solution. Following a 72-hour period, the films were weighed, and a formula was used to determine the percentage of moisture absorption²⁵.

PMA = (Final weight – Initial weight) / Initial weight x 100

In vitro disintegration test:

The USP disintegration apparatus measures the disintegration time of prepared films, with a good, fast-dissolving oral film requiring a 30-second disintegration time²⁶.

Drug content:

The UV spectrophotometer technique was used to determine the drug composition of the films. After being immersed in 6.8 pH phosphate buffer and swirled for an hour, a 2x3 cm2 strip was filtered. Absorption at λmax of 244 nm was recorded. The drug content was calculated using standard curve values, and the results are shown in Table 2.

Table 2: Evaluation of Physical Parameters for Irbesartan Fast Dissolving Buccal Films

Formulation	Weight uniformity (gms)	Drug content (mg/film)	Film thickness (mm)	Dispersion test	Folding endurance (%)	Curling	Surface pH	Swelling Index
F1	1.12	74.02±0.01	0.034	Passed	86	Absent	6.6±0.09	44.21±0.25
F2	1.15	74.04±0.01	0.034	Passed	89	Absent	6.8±0.02	67.15±0.65
F3	2.13	74.05±0.01	0.034	Passed	91	Absent	6.6±0.01	71.51±0.22
F4	2.36	75.00±0.01	0.034	Passed	96	Absent	6.7±0.05	80.54±0.12
F5	2.45	74.06±0.01	0.034	Passed	92	Absent	6.7±0.04	68.44±0.05
F6	2.59	74.08±0.01	0.034	Passed	93	Absent	6.7±0.03	72.10±0.68
F7	2.79	74.09±0.01	0.034	Passed	95	Absent	6.7±0.08	69.45±0.42

Differential scanning calorimetry (DSC):

Using indium, tin, and zinc as internal standards for calibration, the Differential Scanning Calorimeter (METTLER) was used to perform differential scanning calorimetry (DSC). Two to ten milligramme samples were cooked to 300 degrees Celsius in aluminium pans. Figure 4 shows the heated probes under nitrogen flow and atmosphere³⁰ and shown in figure 4

Scanning Electron Microscopy (SEM):

The prepared film's morphology was examined using a scanning electron microscope (SEM), attached to slab surfaces with double-sided adhesive tape, and a 1000X magnification photomicrograph was taken.

Fig 5: Scanning electron microscope photograph of pure drug and Optimized formulation (F4)

Stability studies:

Accelerated stability experiments were conducted for six months at 40°C and 75% relative humidity on the optimised film formulation to evaluate physical alterations and drug release patterns.

RESULTS AND DISCUSSION:

The medication candidate Irbesartan, an angitension II receptor antagonist used to treat hypertension, is the main subject of this investigation. It is a promising formulation for overcoming low bioavailability associated with oral administration a drug for known its poor oral bioavailability. This route provides sustained drug delivery, leading to more consistent blood pressure control, improved patient compliance and reduced dosing frequency Irbesartan buccal films offer a promising alternative to traditional oral tablets, potentially enhancing drug absorption and providing a convenient and effective was to treat hypertension and other related conditions.it is suitable for patients who have difficulty of swallowing pills, require rapid onset of action. Irbesartan is white and soluble in phosphate buffer buffer with a pH of 6.8, alcohol, and water. The goal of the project is to use the solvent evaporation process to develop fast-dissolving films that will dissolve more quickly and have higher bioavailability. Propylene glycol served as a plasticizer, sodium saccharin served as a sweetener, and polyvinyl alcohol and HPMC E5 were chosen as the film-forming agents. In the concentration range of 2–10 µg/mL, it was discovered that the spectrophotometric approach for estimating irbesartan in given media was linear and acceptable in Beer’s law. Six weighted samples were used to assess the repeatability of the approach, which showed that it was suitable for irbesartan quantification in dissolving media.

Irbesartan is classified as a drug in class II of the biopharmaceutical categorization system. Because of its extremely poor solubility in aqueous fluids, experiments on saturated solubility were carried out. Comparing irbesartan to all of the dissolving fluids, the saturated solubility experiments revealed that it was most soluble in 6.8 pH phosphate buffer. PVA, HPMC E5, and solvent casting techniques were used to create irbesartan fast-dissolving buccal films. HPMC E5 was used in increasing concentrations in the formulations F1 through F7. HPMC is a popular choice as a fil forming agent in buccal films due to its excellent fil forming ability so that it can be easily processed into thin, flexible films that can adhere to the buccal mucosa and release the at the desired rate. The nature of polymer is hydrophilic, so it allows swelling in the presence of saliva, enhancing mucoadhesion and drug release. It can be used to control the release rate of drugs by varying its concentration and molecular weight. It is generally recognised as safe (GRAS) biocompatible and biodegradable making it suitable for pharmaceutical applications. Compared to other cellulose derivatives like HPC, HPMC is less hygroscopic and has a different pattern, resulting in slightly different film properties for buccal films. Similarly, natural polymers like chitosan- polysaccharide with mucoadhesive properties, but it may have higher cost and be more challenging to process into films than HPMC. So, based on past studies HPMC was selected as film forming agent with varying concentrations. By using the solvent casting approach, buccal films with irbesartan were prepared. All prepared films were seen to be clear, yellow-colored, elastic, smooth, non-sticky, and free of any apparent particle matter³¹. The findings show that when polymer concentration changed, so did the films' weights. Though not much, the weight of the film increased as the polymer concentration increased. Polymer concentration determines the thickness of a fast-dissolving film. A micrometre screw gauge was used to determine each mouth-dissolving film's thickness. With a relatively low standard deviation value, the thickness was found to fluctuate between 0.3 and 0.9 mm. The technique utilised to formulate the films results in uniformly thick films, which means that dose accuracy in each film may be guaranteed when the standard deviation value is extremely low. The thickness measurement findings show that the thickness of the fast-dissolving film rises with polymer concentration.

The folding durability of a film provides insight into its brittleness. The prepared films had folding endurance values ranging from 86 to 96 percent. 96% folding endurance was observed in the optimised F4 film. The findings shown that the folding durability of fast-dissolving films rises with plasticizer content. It was discovered that the pH of the films' surfaces ranged from 6.5 to 6.7. All of the formulations' surface pH values were almost neutral, suggesting that films may be less likely to irritate the buccal mucosa and, as a result, more palatable to patients. The plasticizer concentration of 30% w/w used in the film composition was tasteful and remained intact when subjected to pressure. Maximum strength was therefore attained. The prepared films' percentage of swelling was measured in a pH 6.8 phosphate buffer. The findings led to the conclusion that the fast-dissolving film's swelling index rises with polymer content. The moisture-sorption characteristics of the FDF formulations are anticipated to be influenced by the polymers employed in them. The range of percentage moisture uptake was 2.3% to 5.5%, with an overall trend showing that moisture uptake increased as both the polymer ratio and the degree of plasticizer increased. Between 95.71 and 99.10 percent of the films' total drug content was determined via evaluation. T50, T90, DE5% first order rate constant, and Hixon crowell were computed from the dissolving data, and the values for these parameters were found to be 2 minutes 36 seconds, 12 minutes 30 seconds, and 42%, respectively, for the film formulation F4 made by HPMC E5 (400 mg).

The films exhibited a nearly consistent drug content, satisfying the 85–115% USP standards. The consistent dispersion of the drug content over the films was observed, with no significant variation found. Using the Franz diffusion cell device, permeability tests were carried out on every film composition. Using HPMC E5 (400 mg), the F4 formulation demonstrated an average drug release of 99.29% in 15 minutes when compared to other formulations. Figure 2 displays the medication release profiles. The concentration-dependent and linear drug release rates from film formulations were demonstrated by the first-order release rate constant (K1), which suggested that the drug was released by polymer erosion and then diffusion from the polymeric matrix. The linear W01/3-Wt1/3 vs. time graphs revealed R2 values between 0.92 and 0.99, showing that the medication was released from the film formulations. The Hixson crowell constants varied from 0.01413 to 0.05827.

In the case of Irbesartan, the principal peaks were seen at wave numbers of 3444.19 cm-1 (N-H stretching), 2959.86.00 cm-1 (C-H stretching), 2873.00 cm-1 (C-C stretching), and 1732.79 (C=O stretching). All of the principal peaks in the pure Irbesartan medication were present in the optimised F4 film formulation, demonstrating that there was no interaction between the medication and the polymers employed in the formulation. The polymers utilised in the formulation and the medication do not interact in this way. A large endothermic peak at 189.3°C was visible on the DSC thermogram of the irbesartan buccal film made using the solvent casting process, whereas the carrier HPMC E5 endothermic peak was observed at 67.1°C. SEM examination revealed that the drug's F4 formulation had a uniform, smooth surface. Accelerated Stability Studies revealed no appreciable alterations in the films' appearance or properties upon storage, nor any notable variations in the drug release from the films. As a result, it was discovered that the drug release properties of rapidly disintegrating films were rather consistent.

CONCLUSION:

Good film qualities were demonstrated by the dispersion test, folding durability, drug content, thickness measurement, and other factors of the study's fast-dissolving films. It was discovered that the produced films were homogeneous and flexible, and that after 15 minutes, 97% of the medication had been released from the F4 film formulation—a desirable feature for quick absorption. Therefore, it was discovered that Irbesartan fast-dissolving buccal films were appropriate for producing superior therapeutic benefits in the management of hypertension.

ACKNOWLEDGEMENT:

The authors express their gratitude to Dr.Reddy’s Lab, Hyderabad, Dow chemical’s Asia Pvt. Ltd., Mumbai and Yarrow chem, Mumbai. The authors are thankful to the management of Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Guntur for providing the facilities to carry out the research work.

CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this investigation.

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Received on 31.08.2024 Revised on 27.02.2025

Accepted on 04.06.2025 Published on 13.01.2026

Available online from January 17, 2026

Research J. Pharmacy and Technology. 2026;19(1):97-104.

DOI: 10.52711/0974-360X.2026.00015

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

S. No.	Ingredients/10Films	F1	F2	F3	F4	F5	F6	F7
1	Irbesartan (mg)	750	750	750	750	750	750	750
2	Hydroxypropyl methyl cellulose (HPMC E5)	250	300	350	400	450	500	550
3	Polyvinyl Alcohol (PVA)	200	200	200	200	200	200	200
4	Propylene glycol	30	30	30	30	30	30	30
5	Sodium Saccharin	20	20	20	20	20	20	20
6	Water (ml)	q.s	q.s	q.s	q.s	q.s	q.s	q.s