.svg)
.jpg)
Swallowing difficulties affect a substantial portion of the elderly population, and pediatric patients frequently resist conventional tablets and capsules. The pharmaceutical industry has responded by developing dosage forms that eliminate the need for swallowing altogether.
Orally dissolving strips allow placing a thin polymer film on the tongue, where it disintegrates within seconds and releases the drug for absorption through the buccal mucosa or gastrointestinal tract. The format offers formulation flexibility that conventional solid dosage forms cannot match.
The polymer matrix composition, plasticizer selection, and API incorporation method determine whether the strip releases its drug load within seconds or over several hours. This adaptability makes oral dissolving films suitable for different therapeutic applications.
Immediate-release strips disintegrate within 30 seconds when placed on the tongue. The drug disperses rapidly in saliva and either absorbs through the oral mucosa or enters the gastrointestinal tract after swallowing. Hydrophilic polymers such as pullulan, hydroxypropyl methylcellulose (HPMC), and polyvinyl alcohol form the base. Superdisintegrants such as crospovidone or sodium starch glycolate accelerate breakdown.
Drugs requiring a rapid onset of action fit this profile. Analgesics for acute pain, antiemetics for nausea, and antihistamines for allergic reactions benefit from immediate release. Ondansetron strips for chemotherapy-induced nausea eliminate the need for water during episodes where swallowing is difficult. Cetirizine strips can provide faster relief from allergic rhinitis compared to tablets because partial buccal absorption bypasses hepatic first-pass metabolism.
Sustained-release strips extend drug release over several hours. This reduces dosing frequency and maintains therapeutic plasma concentrations.
Chronic therapies benefit from this format. Antihypertensives, antidepressants, and antidiabetic agents can be formulated into sustained-release strips. The challenge lies in achieving zero-order release kinetics within the limited thickness of a strip (typically 50-500 μm).
Bilayer or multilayer structures offer one solution. The outer layer provides immediate drug release for a rapid therapeutic effect. The inner layer contains the drug embedded in a sustained-release polymer matrix. This dual-phase release mimics the pharmacokinetic profile of modified-release tablets but in a format that does not require swallowing.
Matrix-type strips use a single polymer blend with varying hydrophilicity. As saliva penetrates the matrix, the drug diffuses outward at a controlled rate. Reservoir-type strips encase the drug in a polymer membrane with defined permeability. Both designs require validation through dissolution studies to confirm that release profiles match the intended therapeutic window.
Mucoadhesive strips adhere to the buccal or gingival mucosa and release the drug locally over 15 minutes to several hours. Bioadhesive polymers such as chitosan, carbopol, and sodium alginate interact with the mucin layer through hydrogen bonding, electrostatic attraction, or hydration-induced swelling.
This format suits localised oral conditions. Topical anesthetics for toothache, antimicrobial agents for oral ulcers, and antifungal treatments for oral candidiasis deliver higher drug concentrations at the site of action without systemic exposure. Ofloxacin mucoadhesive strips treat periodontal infections more effectively than systemically administered antibiotics because the drug remains in contact with infected tissue longer.
Mucoadhesive strips also enable transmucosal absorption for systemic drugs. The buccal mucosa has rich vascularization and lacks the enzymatic activity present in the gastrointestinal tract. Drugs absorbed here enter systemic circulation directly via the jugular vein, bypassing hepatic metabolism.
Embedding nanoparticles or microparticles within the strip matrix enhances the bioavailability of lipophilic or poorly soluble drugs. Particle size reduction increases surface area, accelerating dissolution. Nanoparticles (10-1000 nm) penetrate the mucosa more effectively than larger particles, enabling direct cellular uptake.
Solid lipid nanoparticles, polymeric nanoparticles, and nanosuspensions have been incorporated into oral dissolving films. Several anticancer agents, antidiabetic drugs, and antifungal agents benefit from this approach. These drugs have poor aqueous solubility, which limits their oral bioavailability in conventional dosage forms.
Stability studies are critical for nanoparticle-loaded strips because particle aggregation during storage can compromise dissolution performance and therapeutic efficacy.
Combination strips deliver two or more drugs simultaneously, each with distinct release profiles. A bilayer structure separates incompatible drugs or provides sequential release, one layer for immediate effect, another for sustained action.
Fixed-dose combinations reduce pill burden and improve adherence in chronic diseases. Antihypertensive combinations, antihistamine-decongestant combinations, and analgesic-antipyretic combinations have been formulated into bilayer strips.
Paracetamol, meloxicam, and valdecoxib have been formulated into immediate-release strips for rapid pain relief. Paracetamol's high water solubility makes it straightforward to incorporate. Meloxicam and valdecoxib require solubilization strategies such as inclusion complexes with β-cyclodextrin or solid dispersion with polyethylene glycol.
Ondansetron and domperidone strips address nausea and vomiting where swallowing is compromised. Ondansetron's rapid buccal absorption provides faster relief than conventional tablets. Domperidone strips help pediatric patients who refuse liquid formulations.
Cetirizine, loratadine, and diphenhydramine strips treat allergic rhinitis and urticaria. The format eliminates the drowsiness-inducing syrups often rejected by parents for daytime use in children.
Salbutamol sulphate strips offer an alternative to inhalers for patients with poor inhalation technique. While not replacing rescue inhalers for acute bronchospasm, they provide bronchodilation through systemic absorption after swallowing.
Clonazepam, fluoxetine, and zolpidem have been developed as oral dissolving films. Psychiatric patients benefit because the format prevents "cheeking” (hiding tablets under the tongue to avoid taking medication.) Sleep disorder patients appreciate zolpidem strips that do not require water intake before bed.
Nitrates and amlodipine strips provide alternatives for elderly patients with dysphagia. Sublingual nitrate absorption through mucoadhesive strips delivers rapid relief during angina attacks.
Ofloxacin mucoadhesive strips treat localized oral infections. Acyclovir strips deliver antiviral therapy for herpes simplex without systemic side effects when used buccally.
Metformin HCl has been formulated into sustained-release strips to reduce gastrointestinal side effects and improve adherence in Type 2 diabetes management.
Energy supplements, cognitive enhancers, and immune support formulations have entered the market as orally dissolving strips. These products target health-conscious consumers seeking convenient supplementation.
For detailed insights into how this technology has transformed drug delivery and the specific advantages it offers over traditional formats, read our blog post on the rise of orally dissolving films for tailored treatments, which examines the market drivers, technological innovations, and clinical applications that position oral films as a strategic platform for modern pharmaceutical development.
The oral dissolving strip market continues expanding beyond over-the-counter products into prescription drugs. Technological advances in polymer science enable more sophisticated release profiles. pH-sensitive polymers trigger dissolution in specific gastrointestinal regions. Enzyme-triggered release responds to biological signals. Temperature-sensitive formulations remain stable at room temperature but activate at body temperature.
Personalized medicine applications are emerging. 3D printing technology allows on-demand manufacturing of strips with patient-specific doses. This suits pediatric dosing, where weight-based calculations require precise but non-standard amounts.
Vaccine delivery through oral dissolving strips represents a frontier area. Mucosal immunity induced by buccal vaccine administration offers advantages over injectable vaccines. Hormonal therapies formulated as strips provide discreet administration for hormone replacement therapy or contraception.
Contract manufacturers with expertise in oral thin film development support pharmaceutical brands in lifecycle management strategies reformulating off-patent drugs into patient-preferred formats extends market presence and differentiates products in competitive generic markets.
ZIM Laboratories Limited is a therapy-agnostic and innovative drug delivery solution provider focusing on enhancing patient convenience and treatment adherence to drug intake. We offer a range of technology-based drug delivery solutions and non-infringing proprietary manufacturing processes to develop, manufacture, and supply innovative and differentiated generic pharmaceutical products to our customers globally. At ZIM Labs, we provide our customers with a comprehensive range of oral solid value-added, differentiated generic products in semi-finished and finished formulations. These include granules, pellets (sustained, modified, and extended-release), taste-masked powders, suspensions, tablets, capsules, and Oral Thin Films (OTF).
