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Sublingual Thin Films

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Sublingual thin films offer rapid, precise drug delivery, dissolving quickly under the tongue. Bypasses the GI tract for fast absorption and enhanced patient compliance.

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Specifications

  • Thickness: 20-200 microns, customizable based on dissolution requirements
  • Custom Sizes: 2-8 cm²
  • Dissolution: 5–30 seconds
  • Loading up to 65mg per film
  • Safe, GRAS excipients
  • Single and multi-layer systems
  • Long-term stability for reliable storage

Quantifiable plasma levels as early as 5 minutes post-dose.

Bypasses first-pass metabolism.

Reduced API waste with exact dosage.

No water needed.

Dissolvable or insoluble options.

Compact, easy-to-use packaging.

Thin Film

Drug Matrix

Specifications

  • Thickness: 20-200 microns, customizable based on dissolution requirements
  • Custom Sizes: 2-8 cm²
  • Dissolution: 5–30 seconds
  • Safe, GRAS excipients
  • Loading up to 65mg per film
  • Single and multi-layer systems
  • Long-term stability for reliable storage

How it Works

Sublingual thin films leverage the high vascularity of the sublingual mucosa for direct drug absorption into the bloodstream, bypassing first-pass metabolism and delivering therapeutic effects with remarkable speed.

Place the film under the tongue, where it rapidly dissolves.

The API is released and absorbed directly through the sublingual mucosa.

The drug enters the bloodstream for systemic effects, bypassing digestive processes.

Benefits for Your Patient

Sublingual thin films deliver fast-acting, effective treatment with maximum convenience and minimal complications.

  • Immediate onset for rapid symptom relief
  • No water required—can be taken anywhere
  • Discreet and easy to carry
  • Avoids digestive tract issues associated with oral medications
  • Eliminates the need to swallow pills
  • Suitable for patients with dysphagia
  • Ideal for conditions requiring rapid intervention

CAPABILITIES

ARx offers comprehensive support throughout your development journey, from feasibility studies to full-scale production. Backed by decades of experience in polymer science and thin film technology, we ensure a reliable, high-quality sublingual film product.

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Dosage Forms

Curious how sublingual thin films compare to traditional dosage forms? Explore the benefits and find the perfect solution for your unique formulation needs.

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FAQs

Sublingual thin films are ideal for APIs requiring rapid onset of action, those with poor oral bioavailability due to first-pass metabolism, and molecules that benefit from direct absorption into the bloodstream. They’re particularly effective for emergency medications, CNS drugs, hormones, and compounds sensitive to digestive degradation.

Sublingual films offer significant advantages: rapid onset (plasma levels detectable within 5 minutes), enhanced bioavailability by bypassing first-pass metabolism, precise dosing without liquid measurement, and portability resulting in improved patient compliance. This delivery system can create meaningful differentiation for your product in competitive markets.

Most small molecule APIs and even peptides with appropriate solubility and permeability characteristics are suitable for sublingual delivery. Our advanced formulation capabilities can accommodate many challenging compounds through solubility enhancement, permeation promoters, and specialized excipients. A feasibility study can determine your API’s suitability.

Our sublingual films typically dissolve within 5-30 seconds, depending on formulation requirements. This rapid dissolution ensures quick drug release for immediate absorption through the highly vascularized sublingual mucosa, making them ideal for situations requiring prompt therapeutic response.

Sublingual films offer several key advantages: significantly faster onset of action, higher bioavailability, avoidance of first-pass metabolism, no water required for administration, discreet and portable format, elimination of swallowing difficulties, and precise, consistent dosing.
Yes, sublingual films significantly enhance compliance through ease of use without water, discreet administration, elimination of swallowing difficulties, pleasant taste options, portable packaging, and rapid onset of effect. These benefits are especially valuable for patients who struggle with traditional oral medications.
Our sublingual films can accommodate various APIs, particularly those benefiting from rapid absorption and bypassing first-pass metabolism. We’ve successfully formulated films with hormones, analgesics, anti-emetics, cardiovascular drugs, and CNS-active compounds, with API loads up to 65mg per film.
Sublingual films deliver the API directly to the highly vascularized tissue under the tongue, allowing immediate absorption into the bloodstream while bypassing first-pass metabolism in the liver. This direct route can improve bioavailability by 30-80% compared to oral administration of the same compound.

Our sublingual films utilize pharmaceutical-grade film-forming polymers, plasticizers, disintegrants, taste-masking agents, and permeation enhancers. All excipients are USP/NF compendial or GRAS and selected specifically for their compatibility with sublingual delivery and rapid dissolution characteristics.

Yes, our sublingual films can be extensively customized for size, thickness, dissolution rate, taste profile, and API load. We can develop specialized formulations for pediatric populations, geriatric patients, and those with specific sensitivities or requirements.

Our development follows a structured approach: feasibility assessment, prototype development, analytical method establishment, formulation optimization, stability studies, process development, clinical supplies manufacturer and regulatory documentation. Each phase incorporates quality-by-design principles to ensure successful commercialization.

Sublingual thin films are individually packaged in sealed pouches that protect from moisture and oxygen. Depending on formulation specifics, shelf life typically ranges from 24-36 months at ambient environmental conditions. Most formulations are stable at room temperature, making them convenient for patients and reducing distribution complexities.

Let’s Collaborate On Your Sublingual Thin Film Needs

Questions about our sublingual thin film options? Curious about application for your therapeutic area? Talk to our experts today about your needs.

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