Orally Dissolving Strips: A Novel Formulation for Quick Drug Absorption

Ketan Patil , Shyam Patil , Lokesh Chaudhari , Divyesh Gahivad , Mohammed Awais , Shaikh Habiburrahman, Nazeer Ahmed,

doi:10.5281/zenodo.15179847

Research Paper | Open Access
Volume 03 | Issue 04 | Article Id IJPS/250304089

Orally Dissolving Strips: A Novel Formulation for Quick Drug Absorption
Ketan Patil * Shyam Patil Lokesh Chaudhari Divyesh Gahivad Mohammed Awais Shaikh Habiburrahman Nazeer Ahmed
Dr. Uttamrao Mahajan College of B Pharmacy, DBATU University.

Abstract

The present study focuses on the formulation and evaluation of orally dissolving strips (ODS) of paracetamol to enhance patient compliance and provide rapid drug release. The strips were prepared using a two-phase method with hydroxypropyl methylcellulose (HPMC) as the film-forming polymer, glycerin as a plasticizer, and amaranth as a coloring agent. The formulated ODS were subjected to various physicochemical evaluations, including thickness measurement, drug content uniformity, disintegration time, and dissolution studies, to ensure compliance with pharmacopeial standards. Thickness analysis confirmed uniformity, with an average thickness of 133.3 ± 7.5 µm, ensuring mechanical stability and consistent drug distribution. The dissolution study demonstrated a rapid drug release profile, with 99.1% of the drug released within five minutes, indicating efficient drug availability for absorption. The results confirm that the formulated ODS meet the required pharmacopeial limits, making them a promising alternative to conventional dosage forms for faster therapeutic action.

Keywords

Orally dissolving strips, Paracetamol, Rapid drug release, Hydroxypropyl methylcellulose (HPMC), Film-forming polymers, Patient compliance, Dissolution studies, Disintegration time, pharmaceutical formulation, Analgesic strips.

Introduction

The oral route is the most preferred and convenient method of drug administration due to its cost-effectiveness, ease of use, and high patient compliance. However, conventional oral dosage forms like tablets and capsules present challenges for specific populations, including pediatric, geriatric, and bedridden patients, as well as individuals with dysphagia or fear of choking. To address these issues, innovative drug delivery systems such as orally dissolving strips (ODS) have been developed, offering rapid disintegration in the mouth without the need for water. Orally dissolving strips are thin, flexible films that incorporate active pharmaceutical ingredients (APIs) along with excipients like film-forming agents, plasticizers, and flavoring agents. Upon placement on the tongue, they dissolve quickly, allowing for rapid drug release and absorption through the oral mucosa, thereby offering a faster onset of action compared to traditional tablets. This drug delivery system enhances patient compliance, especially in emergency situations, during travel, or for individuals with limited access to water. Paracetamol, commonly referred to as acetaminophen, is a widely utilized medication known for its effectiveness in relieving mild to moderate pain and reducing fever. Despite its extensive use in tablet, capsule, and liquid forms, these traditional formulations may not be suitable for all patients, particularly children and the elderly. To overcome these limitations, we have developed paracetamol orally dissolving strips using hydroxypropyl methylcellulose (HPMC) as the primary film-forming polymer due to its excellent film-forming properties, safety, and compatibility with various pharmaceutical excipients. The objective of this research is to optimize the formulation of paracetamol ODS by evaluating the physicochemical properties, mechanical strength, disintegration time, and drug release profile.

The Study Involves the Preparation of Four Formulations:

Table 1: Ingredients Used in the Development of Paracetamol ODS Formulation

Formulation	Ingredients
Formulation 1	HPMC, Glycerin, Ascorbic Acid, Methyl Paraben, Sucrose, Peppermint Oil, Water.
Formulation 2	HPMC, Glycerin, Ascorbic Acid, Methyl Paraben, Sucrose, Peppermint Oil, Ethanol, Paracetamol, Water.
Formulation 3	HPMC, Glycerin, Ascorbic Acid, Methyl Paraben, Sucrose, Peppermint Oil, Paracetamol, Ethenol Xanthin gum, Water.
Formulation 4	HPMC, Glycerin, Ascorbic Acid, Methyl Paraben, Sucrose, Peppermint Oil, Paracetamol, Ethenol, Amaranth solution, Water.

1. Formulation 1: Base formulation with excipients only to evaluate film-forming ability.

2. Formulation 2: Excipients with paracetamol to assess drug loading and distribution.

3. Formulation 3: Trial formulation with super disintegrant (Xanthan gum) for rapid disintegration evaluation

4. Formulation: Final optimized formulation containing excipients, paracetamol, and a coloring agent to enhance aesthetic appeal.

These fast-dissolving strips aim to improve patient compliance, provide rapid relief from pain and fever, and serve as an effective alternative to conventional oral dosage forms.

Key Features of Fast Dissolving Films (FDFS)

Easy to administer
Eliminates choking risk
Avoid First-pass metabolism
Accurate dosing
Ideal for acute condition
Lower dosage requirement
No-invasive alternative

Advantages of Fast Dissolving Films (AFDF)

Easy to take
No water needed
Better taste
Longer shelf life
Improves patient compliance
Faster action with less liver impact
Local effect in the mouth
Quick dissolving

Disadvantages Of Fast Dissolving Films (DFDF)

Limited drug dose (1–30 mg only)
Difficulty incorporating high drug doses
Fragile and prone to tearing
Sensitive to moisture and humidity
Expensive manufacturing process

Types of Orally Dissolving Strips (TODS)

For ease of understanding, fast dissolving technologies can be categorized into three major groups:

1. Lyophilized Systems

2. Compressed Tablet-Based Systems

3. Oral Thin Films (OTFs)

1. Lyophilized Systems

Lyophilized systems are the most commercially successful due to their high sales volume and global approvals. This technology involves preparing a suspension or solution of the drug with structural excipients, which is then molded into tablet-like units using blisters or molds. The units are frozen and subjected to lyophilization (freeze-drying), creating highly porous structures. This porosity enables quick saliva or water penetration, leading to rapid disintegration.
The drug loading capacity in these systems varies based on the solubility of the active pharmaceutical ingredient (API). While lyophilized systems may have a slightly lower dose capacity compared to tablet-based systems, they offer faster disintegration and the ability to incorporate taste-masking agents effectively.

2. Compressed Tablet-Based Systems

Compressed tablets are manufactured using conventional tableting techniques, primarily through direct compression. The disintegration speed of these tablets is enhanced by incorporating water-soluble excipients, super disintegrants, or effervescent agents, which facilitate rapid moisture penetration.
The hardness and friability of the tablets depend on the formulation and compression process, affecting their disintegration rate and packaging requirements. Some tablets require specialized packaging (e.g., CIMA Labs' PackSolv) to maintain product integrity.
An advanced example includes Biovail’s Fuisz Technology, which uses the Shearform process to create drug-loaded candy floss-like structures for tableting. While compressed tablets can accommodate higher drug doses and taste-masked particles, their disintegration time is generally slower compared to lyophilized systems and thin films.

3. Oral Thin Films (OTFs)

Oral Thin Films (OTFs), also known as oral wafers, are flat, flexible films designed for administration in the oral cavity. Although this technology has been around for some time, it has gained significant attention in recent years for fast-dissolving drug delivery.
Initially popular in the confectionery and oral care industries (e.g., breath freshening strips), OTF technology has evolved for pharmaceutical applications, including vitamins, OTC medications, and prescription drugs. Companies experienced in transdermal drug delivery have adapted their polymer coating technologies to develop OTFs. These films dissolve quickly upon contact with saliva, offering rapid onset of action, improved patient compliance, and ease of administration without the need for water.

Formulation Methods of Orally Dissolving Strips (ODS)

The preparation of orally dissolving strips involves various conventional and advanced techniques, each offering specific advantages depending on the desired film characteristics. The following methods are commonly employed for the formulation of ODS:

1. Solvent Casting Method (Method Used in This Study)

In this research, paracetamol ODS were prepared using a modified two-phase solvent casting method, designed to enhance drug dispersion and film uniformity. The process involved two separate phases:

Phase 1: Hydroxypropyl methylcellulose (HPMC) was dissolved in 10 ml of distilled water under continuous mechanical stirring to form a viscous polymeric solution.

Phase 2: Paracetamol was dissolved in another 10 ml of distilled water with the addition of ethanol, using a hot plate to ensure complete dissolution. After preparing both solutions, they were combined with plasticizers (glycerin), sweeteners, amaranth coloring agent, and menthol oil to improve the film’s organoleptic properties. The final mixture was cast onto an oil-coated petri dish to prevent sticking and was dried in a hot air oven at 50–55°C. Once dried, the films were carefully peeled off and cut into uniform strips. This method offers enhanced drug distribution, better control over film thickness, and improved mechanical properties of the strips.

Figure 1: Solvent Casting Method for Paracetamol

2. Solvent Casting Method

This is one of the most widely used techniques for ODS preparation. In this method, the film-forming polymer is dissolved in a suitable solvent, typically water or alcohol. The drug is either dissolved or uniformly dispersed in the polymeric solution along with plasticizers, sweeteners, colorants, and flavoring agents. The resulting mixture is cast onto a flat surface to form a uniform layer, dried under controlled temperature conditions, and then peeled and cut into desired sizes.

Figure2. Industrial Setup for Solvent Casting Method in ODS Preparation

3. Hot-Melt Extrusion Method

Hot-melt extrusion is a solvent-free process, ideal for drugs that are stable at high temperatures. The drug, polymer, and excipients are blended and introduced into an extruder where they are melted and mixed to form a homogeneous mass. This mass is then extruded through a flat die to create thin films. After cooling, the films are collected and cut. This method provides uniform drug distribution and enhances the bioavailability of poorly soluble drugs.

Figure 3: Schematic Representation of the Hot-Melt Extrusion Process

4. Solid Dispersion Extrusion Method

In this technique, the drug is dispersed within a polymer matrix to form a solid dispersion, enhancing solubility and dissolution rates. The drug-polymer mixture is melted, homogenized, and extruded to form thin films. Solid dispersion extrusion is particularly effective for improving the bioavailability of poorly water-soluble drugs.

Figure 4: Schematic Representation of the Solid Dispersion Extrusion Process

5. Semi-Solid Casting Method

This method involves the preparation of a semi-solid gel by dissolving the polymer and drug in a suitable solvent, often with the addition of plasticizers. The semi-solid mass is then cast onto a flat surface to form a film of uniform thickness. After drying, the film is peeled off and cut into strips. This method allows precise control over drug content and film properties.

6. Rolling Method

In the rolling method, the polymer-drug solution or suspension is continuously fed between rollers to form thin films. The film passes through heated rollers to facilitate solvent evaporation, ensuring uniform thickness and consistency. This technique is stable for large-scale production due to its continuous nature and high throughput.

Figure 5: Schematic Representation of the Rolling Method

7. Other Formulation Methods

Several advanced techniques are being explored to optimize ODS characteristics:

Electrospinning Method: Utilizes an electric field to create nanofibrous films with high surface area, promoting rapid dissolution. Lyophilization (Freeze-Drying) Method: Involves freezing the polymer-drug solution and sublimating the solvent under vacuum, resulting in porous films with fast disintegration. 3D Printing Technology: Allows precise control over film composition, drug loading, and release profiles, offering potential for personalized medicine. Development of Paracetamol Orally Dissolving Strips: Ingredients and Preparation Method (Research Work on ODS) In this study, we formulated orally dissolving strips (ODS) of paracetamol using a stepwise approach. The development was carried out in four stages, each focusing on the gradual addition of key components:

Formulation 1: Base Film (Only Excipients, No Drug, No Color)

Ingredients Used:

HPMC (Film-forming agent)

Glycerin (Plasticizer for flexibility)

Sucrose (For taste)

Methyl paraben
Ascorbic acid

Distilled water (Solvent)

Table 2: Stepwise Preparation of Base Film (Only Excipients, No Drug, No Color)

Step no.	Preparation process
Step 1	HPMC was dissolved in distilled water with continuous stirring.
Step 2	Glycerin, Ascorbic acid, methyl paraben , sucrose , paper-mint oil water were added into another beaker to improve flexibility and taste and add both solution and shake.
Step 3	The solution was cast into Petri dishes and dried in a hot air oven at 50°C to form a thin film.
Step 4	Once dried, the film was cut into strips and evaluated for thickness, flexibility, and transparency.

Formlation 2: Film with Paracetamol (Excipients + Drug, No Color)

Table 3: Stepwise Preparation of Film with Paracetamol (Excipients + Drug, No Color)

Step no.	Preparation process
Step 1	Paracetamol was dissolved in ethanol and added to the excipient solution.
Step 2	other excipients expect amaranth coloring agent were added into paracetamol solution. And add HPMC solution into excipients solution and shake continuous.
Step 3	The final solution was cast, dried, and cut into strips.
Step 4	The final strips were evaluated for dissolution time, drug release, and aesthetic appeal.

Formulation 3: Trial formulation with super disintegrant (Xanthan gum) for rapid disintegration evaluation

Table 4: Stepwise Preparation of Trial Formulation with Superdisintegrant (Xanthan Gum)

tep No.	Preparation process
Step 1	Paracetamol was dissolved in ethanol and added to the excipient solution.
Step 2	Xanthan gum and other excipients (except coloring agent) were added to the solution. HPMC solution was mixed in with continuous stirring.
Step 3	The final solution was cast, dried, and cut into strips.
Step 4	Strips were evaluated for dissolution time, drug release, and mechanical properties.

Formulation 4: Final Optimized Strips (Excipients + Drug + Coloring Agent)

Table 5: Stepwise Preparation of Final Optimized Strips (Excipients + Drug + Coloring Agent

Step no.	Preparation process
Step 1	Paracetamol was dissolved in ethanol and added to the excipient solution.
Step 2	A coloring agent (Amaranth red) and other excipients were added into paracetamol solution. And add HPMC solution into excipients solution and stirrer continuous.
Step 3	The final solution was cast, dried, and cut into strips.
Step 4	The final strips were evaluated for dissolution time, drug release, and aesthetic appeal.

Objectives and Results of All Formulations

Table : Objective and Result of All Formulations

Formulation	Objective	Result
F1 (Base Film)	To check film-forming ability of excipients.	Film formed but had no medicinal effect.
F2 (With Paracetamol)	To assess drug incorporation n in the film.	Strips formed but lacked color and patient acceptability
F3 (With Xanthan Gum)	To evaluate xanthan gum as a super disintegrant agent	Strips failed due to poor integrity and mechanical strength.
F4 (Final Optimized)	To improve appearance and acceptability with color/flavor.	Best formulation with fast dissolution, flexibility, and better patient compliance.

Figure 6: Visual Comparison of Orally Dissolving Strips Showing Progressive Formulation Stages – Basic Transparent Strips, Drug-Loaded White Strips, lower white xanthin gum containing strips and Optimized Pink Strips with Enhanced Aesthetic Appeal.

Table: Ingredients Used in Orally Dissolving Strips (For 20 ml Water)

Table 7: Composition of paracetamol orally dissolving strips (ODS) with ingredients, quantities, and their functions

Ingredients	Quantity (for 20 ml water)	Weight/Volume (% w/v)	Purpose
HPMC	0.8	4%	Film-forming agent (creates strip structure)
Glycerin	0.8	4%	Plasticizer (provides flexibility)
Ascorbic acid	0.2	1%	Stabilizer (prevents oxidation)
Methyl paraben	0.1	0.5%	Preservative (prevents microbial growth)
Sucrose	1	5%	Sweetener (improves taste)
Peppermint oil	2-3 drops	__	Flavoring agent (enhances taste and
Amarnath solution (coloring agent)	2-3 drops	__	Coloring agent (improve patient compliance)
Paracetamol	3.73 g	18.65%	Active drug (provides analgesic & antipyretic effect)
Ethanol	2 ml	10%	Co-solvent (helps dissolve paracetamol)
Water	20 ml	100%	Solvent (dissolves all ingredients)

Preparation of Orally Dissolving Strips: -

The oral strips were prepared using the solvent casting method. The procedure involved the following steps:

1. Preparation of Drug Solution:

Paracetamol was dissolved in ethanol to enhance its solubility. The drug solution was then added to the pre-prepared HPMC solution under continuous stirring then into excipients solution and stirrer continuous.

Figure 7: Preparation of Paracetamol and HPMC Solution Using Magnetic Stirring

2. Addition of Excipients and Mixing:

The excipient solution was prepared by dissolving glycerin, ascorbic acid, methyl paraben, sucrose, peppermint oil, and Amaranth coloring agent in a suitable solvent. The drug solution was then added to this excipient mixture, and both solutions were mixed thoroughly using a mechanical stirrer to ensure uniform distribution.

Figure 8: Homogeneous drug-excipient solution for orally dissolving strips

3. Casting and Drying:

The prepared homogeneous solution was poured into Petri dishes and evenly spread to form a thin layer. The solution was dried at 50°C in a hot air oven to form solid strips.

Figure 9: Casting of drug-excipient solution in Petri dishes for film formation

4. Cutting and Evaluation:

Once dried, the form film was carefully removed and cut into uniform strips. The strips were then evaluated for their dissolution time, drug release, and aesthetic appeal.

Figure 10: Cut and dried orally dissolving strips ready for evaluation

Evaluation of Orally Dissolving Strips

"The prepared orally dissolving strips (ODS) were evaluated for various physicochemical parameters to ensure their quality, uniformity, and effectiveness. The following tests were conducted to assess the performance of the formulated strips."

Disintegration Test for Orally Dissolving Strips (ODS)

The disintegration time of orally dissolving strips (ODS) was evaluated using a Digital Programmable Disintegration Apparatus in simulated saliva fluid (pH 6.8) at 37 ± 0.5°C. The strips disintegrated within 35-40 seconds, meeting the standard requirement of ≤ 60 seconds.

Figure 11: Evaluation of Disintegration Time for Orally Dissolving Strips using Digital Disintegration Apparatus

Results & Interpretation

Table 8: Disintegration Time and Observations of Orally Dissolving Strips

Sample Code	Disintegration Time (Seconds)	Observation
ODS-1	35 sec	Completely dissolved
ODS-2	40 sec	No visible residue
ODS-3	38 sec	Uniform disintegration

Weight Variation Test of for orally dissolving strips (ODS)

The weight variation test was conducted to ensure uniformity in the weight of orally dissolving strips (ODS) of paracetamol. The individual weights of randomly selected strips were measured, and the results are below:

Figure 12: Weight Variation Test of Orally Dissolving Stripsd Weights of Strips (g)

Table 9: Observed Weights of Orally Dissolving Strips

Sample No.	Weight (g)
1	0.06
2	0.06
3	0.08
4	0.05

Statistical Analysis:

Figure 13: Bar Graph Representing Weight Uniformity of Orally Dissolving Strips

Mean Weight: 0.0625 g

Standard Deviation (SD): 0.0126 g

Relative Standard Deviation (%RSD): 20.13%

The obtained %RSD is relatively high, indicating noticeable variation in strip weights. Further optimization in formulation and process parameters may be required to ensure uniformity.

Folding Endurance Test

The folding endurance test was conducted to assess the mechanical strength and flexibility of the ODS. Strips were repeatedly folded at the same location until breakage occurred.

Figure 14: Folding endurance test procedure for ODS

Figure 15: Number of Folds Before Breakage for Different Formulations. RESULTS:

The strips exhibited high flexibility, withstanding multiple folds before breaking.

No visible cracks appeared during the test, indicating good mechanical integrity.

The test confirms the robustness of the formulated ODS.

Organoleptic Evaluation

Organoleptic evaluation assesses the sensory characteristics of orally dissolving strips (ODS), including color, odor, taste, texture, and appearance. These parameters play a vital role in patient compliance and overall product acceptability.

Table 10: Organoleptic Evaluation of Orally Dissolving Strips

Test Parameter	Observation	Inference
Colour	Uniform pink	Due to amaranth coloring agent
Odor	Pleasant menthol-like smell	Menthol oil successfully incorporated
Taste	Acceptable, mild sweetness with slight bitterness Effective masking of paracetamol bitterness	Effective masking of paracetamol bitterness
Texture	Smooth and uniform	Proper film formation and polymer dispersion
Appearance	Flexible, non-brittle strips with even thickness Good film integrity and formulation stability	Good film integrity and formulation stability

Figure 16: Organoleptic evaluation of paracetamol orally dissolving strips.

Conclusion: The orally dissolving strips (ODS) meet the required organoleptic standards, ensuring patient compliance and acceptability.

Tensile Strength of Orally Dissolving Strips (ODS)

Introduction

Tensile strength is a key mechanical property of ODS, ensuring they remain intact during handling, packaging, and administration. It prevents premature breaking while maintaining flexibility for rapid dissolution.

Figure 17: Tensile Strength Testing of Orally Dissolving Strips

METHODOLOGY

Tensile strength was evaluated using a Texture Analyzer. A gradually increasing force was applied until the strip broke. The tensile strength was calculated using:

Tensile strength N/mm2 = force at break (N) / width (mm) × thickness (mm)

Figure 18: Tensile Strength Curve of Orally Dissolving Strips

RESULT AND CONCLUSION

The tensile strength test of the prepared orally dissolving strips (ODS) showed a peak strength of 150 N, with the strip breaking after 4 seconds of applied force. The graph exhibited a steady increase in force until rupture, indicating good mechanical integrity. The results confirm that the strips have adequate strength for handling, packaging, and administration while maintaining their fast-dissolving nature. Further optimization of polymer concentration and plasticizer content can enhance flexibility without compromising mechanical stability.

Drug Content Uniformity Test

Drug content uniformity is an essential quality control test to ensure that each dosage unit (e.g., orally dissolving strips) contains the intended amount of active pharmaceutical ingredient (API). This test is performed as per standard pharmacopeial methods to maintain consistency across different samples.

Methodology:

A standard assay method is used to estimate the API content in individual strips. The limit for drug content uniformity is set between 85-115% of the labeled claim. The test ensures that variations in drug content are minimal, providing uniform therapeutic effects.

Figure 19: Bar Graph Representing Drug Content Uniformity of Orally Dissolving Strips

Results and Interpretation:

A bar graph representing drug content uniformity of 10 different strips was analyzed. The drug content values ranged between 97.5% and 99.2%, showing acceptable consistency. The results confirm that all tested strips fall within the pharmacopeial limits, ensuring uniformity.

Moisture Content Determination of Orally Dissolving Strips Using Loss on Drying Method

Moisture content affects the stability and mechanical properties of orally dissolving strips (ODS). This study evaluates the percentage moisture loss (PML) using the Loss on Drying (LOD) method to ensure optimal strip quality.

Materials and Methods

2.1 Materials

Orally dissolving strips

Electronic analytical balance

Hot air oven (60–80°C) or desiccator

2.2 Methodology

1. Initial Weighing (W1): The strip’s weight was recorded before drying.

2. Drying Process: Strips were dried in a hot air oven (60–80°C for 2–4 hours) or a desiccator.

3. Final Weighing (W2): The dried strip was weighed again.

Figure 20: Moisture Content Determination of Orally Dissolving Strips using Loss on Drying (LOD) Method in a Hot Air Oven at 60-80°C.

Results and Discussion

The moisture content of ODS was found to be within 1–5%, ensuring flexibility and stability.

Stability Testing of Orally Dissolving Strips (ODS)

Stability testing ensures that orally dissolving strips (ODS) maintain their physical, chemical, and mechanical properties over time under different environmental conditions. This study follows ICH guidelines (Q1A-R2) to evaluate the stability of ODS.

Methodology

Storage Conditions:

Accelerated Stability: 40°C ± 2°C / 75% RH ± 5% for 6 months. Real-time Stability: 25°C ± 2°C / 60% RH ± 5% for 12 months.

Figure 21: Moisture control during stability testing of orally dissolving strips using a desiccator to prevent excess humidity absorption.

Parameters Evaluated:

Physical appearance (color, texture)
Mechanical properties (flexibility, tensile strength)
Moisture content (LOD method)
Disintegration time
Drug assay (HPLC/UV)

Testing Intervals: 0, 1, 3, and 6 months (Accelerated); 0, 3, 6, 9, and 12 months (Real-time).

Results & Conclusion

ODS stored under accelerated conditions showed increased moisture absorption and loss of flexibility.

Real-time stability testing confirmed that ODS remained physically stable for 12 months, but required moisture protection.

Desiccator storage helped control humidity, preventing excess moisture absorption.

Thickness Testing of Orally Dissolving Strips (ODS)

The thickness test is crucial for ensuring the uniformity and mechanical strength of orally dissolving strips (ODS). Consistent thickness guarantees uniform drug distribution, which is essential for accurate dosing and therapeutic efficacy. According to pharmacopeial standards, ODS thickness should fall within an acceptable range. The thickness of randomly selected strips was measured using a digital vernier caliper, and the average value was recorded.

Result and Discussion

1. Thickness Measurement

A Thickness was measured for three randomly selected strips.

B. Measurements were taken in triplicates using a digital vernier caliper.

C. The average thickness and standard deviation (SD) were calculated.

2. Observed Thickness Values

Table 11: Thickness Measurement of Orally Dissolving Strips

Strip Sample	Thickness (μ m)	Mean ± SD (μ m)
Strip 1	125	133.3 ± 7.5
Strip 2	130	133.3 ± 7.5
Strip 3	145	133.3 ± 7.5

Note: The mean and standard deviation are calculated for all three strips collectively, not individually

3. Interception of Results

A. The thickness of ODS was within the pharmacopeial limit (50-200 µm).

B. The uniformity in thickness ensures proper drug content distribution and mechanical integrity.

Graphical Representation (Bar Chart for Thickness Test

Figure 22: Thickness Test of Orally Dissolving Strips

Dissolution Testing of Orally Dissolving Strips (ODS)

The dissolution test is essential for evaluating the drug release profile of orally dissolving strips (ODS). It ensures that the active pharmaceutical ingredient (API) is released within the specified time for proper therapeutic efficacy. As per pharmacopeial guidelines, ODS should exhibit rapid dissolution, typically within 5 minutes. The test was conducted using a USP Type II (paddle) dissolution apparatus with simulated salivary fluid at 37 ± 0.5°C. The percentage of drug release was measured at specific time intervals.

Results and Discussion (Step-by-Step)

1. Dissolution Study Methodology

A. Apparatus Used: USP Type II (Paddle)

B. Medium: Simulated Salivary Fluid (pH 6.8)

C. Temperature: 37 ± 0.5°C

D RPM (Stirring Speed): 50 rpm

E. Time Points: 30 sec, 1 min, 2 min, 3 min, 4 min, 5 min

F. Detection Method: UV Spectrophotometer at λmax

Figure 23: Dissolution Test of Orally Dissolving Strips

2. Observed Drug Release Values

Table 12: Observed Drug Release Values for Orally Dissolving Strips

Time (min)	% Drug Release (Mean plus/minus S ± D)
0.5	35.2 ± 2.1
1	58.6 ± 3.4
2	78.4 ± 2.9
3	89.5 ± 2.1
4	96.2 ± 1.5
5	99.1 ± 1.2

3. Interpretation of Results

The formulation showed rapid dissolution, achieving 99.1% drug release within 5 minutes, which is within pharmacopeial limits.
The uniform dissolution profile ensures consistent drug availability for absorption.

Graphical Representation of Dissolution Test for ODS

Figure 24: Drug Release Profile of Orally Dissolving Strips

Pharmacopeial Compliance

The results obtained from all the performed tests, including thickness, disintegration, and dissolution, were evaluated against the official pharmacopoeia standards. All parameters were found to be within the acceptable limits, indicating that the formulated orally dissolving strips comply with the required quality standards.

CONCLUSION Orally dissolving strips (ODS) represent a futuristic and innovative drug delivery system with immense potential in the pharmaceutical industry. This study confirmed that the formulated ODS met pharmacopeial standards, ensuring uniform thickness for precise dosing and rapid dissolution for immediate drug availability. The dissolution profile demonstrated that over 99% of the drug was released within 5 minutes, making it highly effective for quick therapeutic action. Given their fast-dissolving nature, ODS offer a promising platform for emergency medical applications. If formulated with critical APIs such as cardiovascular drugs, these strips could be life-saving in conditions like heart attacks, where rapid drug absorption is essential. Their ease of administration, especially without water, further enhances their potential for emergency use, pediatric and geriatric patients, and on-the-go treatment solutions. Overall, ODS emerge as a next-generation dosage form with the potential to revolutionize drug delivery, providing enhanced patient compliance, convenience, and rapid therapeutic action. Future research focusing on stability and clinical efficacy will further solidify their role in advanced pharmaceutical applications.

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