ODF strips and oral dissolving films, made in San Diego, California

What oral dissolving films are

An oral dissolving film (ODF) is a thin, flexible strip of water-soluble polymer, usually pullulan or HPMC, that carries a measured dose of an active ingredient and dissolves in the mouth without water. Saliva breaks the strip down within seconds to about a minute and the contents are swallowed. Published reviews put fast-dissolving films at 1 to 20 square centimeters in area, 5 to 200 microns thick, and able to carry up to about 30 mg of active per strip. For a dietary supplement the strip is a delivery format for ingestion, not a separate regulatory category.

Specifications

How a project runs, in eight steps

1. Project brief

   Every project starts with a written brief: actives, target amount per strip, serving plan, flavor direction, pack count, launch market, claims, timing and forecast. We separate requirements from preferences so the tradeoffs stay visible.

2. Feasibility review

   We check whether the active system fits a film at the requested dose. Load, solubility, taste, moisture sensitivity and dissolve behavior all pull on each other. The review takes 3–5 business days and ends with a yes, a no, or a list of what development has to prove.

3. Formula and flavor development

   The film base is a water-soluble polymer, a plasticizer, sweeteners, flavors and the active. Sensory criteria are written before any sample is judged. Rounds continue until the strip meets the criteria, not until someone in the room likes it. Formula development runs 2–4 weeks; sample iteration 1–3 weeks.

4. Qualified 500-box pilot

   Qualified projects begin with a 500-box pilot: about 10,000 strips in 20-count boxes or 15,000 in 30-count boxes. The pilot runs the complete system, including sachet sealing, carton packout and lot coding. It is production at learning scale, not a lab batch. Pilot manufacturing takes 2–4 weeks after formula, material and packaging approvals.

5. Testing

   Finished strips are checked against the approved specification: appearance, dimensions and weight, moisture or water activity where relevant, seal integrity and coding reconciliation, potency, content uniformity where dose-critical, and microbiological controls suited to the formula. Third-party analytical work runs through ILS Lab. Results are recorded against the lot; testing and release take about a week.

6. Packaging

   Strips are sealed one per high-barrier PET/aluminum/PE sachet and assembled into 20-count or 30-count cartons. Sachet structure, seal width, tear notch, print method, artwork and lot and expiration fields are confirmed before the pilot, because printed components have their own minimums and lead times. Packaging is on the critical path from the first week.

7. Documentation

   Each released lot ships with a Lot Release Packet: finished-product certificate of analysis, certificate of conformance, lot identification, quantity reconciliation, packaging identification and the applicable third-party results. We retain the executed batch record. Lot codes on sachet and carton tie the product back to those records, and the document set is agreed in scoping so retailers, marketplaces and importers get what they ask for.

8. Scale and reorder

   The pilot ends with a locked formula, sensory criteria, packaging specification and testing plan. Reorders run against that specification, so 1,000, 3,000 or 5,000 boxes are a production and purchasing decision rather than a restart.

Oral films compared with other formats

What oral dissolving films are

An oral dissolving film is a thin polymer strip that carries a measured dose and dissolves in the mouth without water. The base is a water-soluble film former. The active, sweeteners, flavors and a plasticizer are mixed into it, cast as a wet layer, dried into a continuous film, then cut into strips.

Peer-reviewed reviews describe fast-dissolving films as 1 to 20 square centimeters in area, 5 to 200 microns thick, carrying up to about 30 mg of active per strip, and disintegrating in 5 to 30 seconds. Those are format-typical figures, not StripWorks specifications. The right numbers depend on the active, the dose and the sensory target.

Buyers search for the format under many names: oral strips, oral thin films, orodispersible films, orally disintegrating strips, melt strips. All describe the same object. Sublingual and buccal describe where a strip is placed, not a different product.

StripWorks makes oral dissolving films for dietary supplement and wellness brands. We do not make drug products, and we do not quote strips containing nicotine, kratom or cannabinoids.

Who uses oral strips

Four kinds of buyers come to us. Private-label and direct-to-consumer supplement brands want a format that stands out, ships flat and needs no water. Clinics and practitioners want a branded product to hand to a patient or sell through their own channel. Brands with a capsule or gummy line want an extension for people who will not swallow pills. Ingredient companies want a finished-format demonstration of their active.

The common thread is a short list of actives at modest doses. Melatonin, vitamin B12, vitamin D3, caffeine with L-theanine, zinc and biotin sit comfortably in a strip. Actives whose usual serving is measured in grams, such as collagen peptides or creatine, do not fit at that serving; a 100 mg collagen strip is a development target in our library, a 10 g scoop is not.

Children, older adults and anyone with swallowing difficulty are the end users the format serves best. A 2023 review in Pharmaceutics notes that orodispersible films benefit pediatric, geriatric and dysphagic populations, and cites dysphagia affecting about 15 million people in the United States.

We work with brands worldwide. Export projects need the destination market, importer and labeling language identified before formula and artwork are locked.

How oral dissolving films are made

A strip is a small engineered system. The film former is a water-soluble polymer. Pullulan, a natural polysaccharide, and hydroxypropyl methylcellulose (HPMC) are the usual choices for supplement films; polyvinyl alcohol (PVA), maltodextrin, starch and gelatin also appear in the literature. The polymer sets dissolve behavior, clarity and strength.

A plasticizer, usually glycerin or a low-molecular-weight polyethylene glycol, keeps the dried film flexible instead of brittle. Sweeteners such as sucralose, stevia extracts or sugar alcohols add sweetness without bulk. Flavors, colors, a saliva-stimulating acid and the active complete the mix.

The commercial process is solvent casting, which the Pharmaceutics review calls the widely preferred technique for practical manufacturing and scale-up. A controlled liquid mass is spread as a uniform wet layer, dried into a continuous film, slit and cut into strips, and each strip is sealed into a sachet. Hot-melt extrusion is a solvent-free alternative used mostly in pharmaceutical work.

What the process cannot fix: an active that is intensely bitter at the target dose, an active unstable around moisture, or a dose that will not fit in a film that still dissolves. Those are formula problems, and feasibility is where they get found.

Dose loading: what fits in a strip

The most useful question a buyer can ask is whether the dose fits. A strip weighs well under a gram. Published work puts a reference strip at under 200 mg total weight with the active at 5 to 30 percent of dry film mass, which is where the often-quoted ceiling of about 30 mg per strip comes from.

That ceiling is not a hard wall. Larger strips, thicker films and multi-strip servings extend it. But every milligram of active displaces polymer, and polymer is what makes the strip a strip. Push loading too far and the film gets brittle, cloudy, slow to dissolve or unpleasant on the tongue.

In our feasibility work, single-active loads up to approximately 250 mg per strip are supported, formulation dependent, on a 22 × 32 mm development format at roughly 50–150 μm dry-film thickness and 100–300 mg finished strip weight. Higher total solids, larger formats and multi-strip servings are developed when a project needs them.

Actives that fit easily: vitamins measured in micrograms such as B12 and D3, melatonin, caffeine with careful flavor work, zinc, biotin, folate and low-dose standardized extracts. Actives that do not fit at their usual serving: collagen, creatine, protein, fiber and any ingredient whose effective dose is a gram or more. We settle the loading question in feasibility, before any development spend.

Taste and mouthfeel engineering

A capsule hides its contents. A strip cannot. Whatever is in the film touches the tongue, so taste and mouthfeel are designed, not decorated.

The tools are sweeteners, flavors, acids, cooling agents and, for difficult actives, physical taste masking such as coating or complexing the active before it goes into the film. Published reviews list ion-exchange resins, microparticles and inclusion complexes as masking approaches. High-intensity sweeteners are common because they add sweetness at milligram levels without competing with the active for space.

Mouthfeel is the other half. A good strip feels thin, dissolves cleanly and leaves no gummy residue. Thickness, plasticizer level and polymer choice set that experience. Too little plasticizer and the strip cracks in the sachet; too much and it feels tacky.

We run sensory development in rounds against written criteria: taste on contact, bitterness, aftertaste, dissolve feel, residue and appearance. The criteria are agreed before the first sample so each review is a decision, not a debate.

Sublingual, buccal and orally dissolving: placement and the ingestion rule

Sublingual means under the tongue. Buccal means against the cheek. Orally dissolving, or orodispersible, means on the tongue, where the strip disperses and is swallowed with saliva. The strip can be identical in all three cases.

For dietary supplements in the United States, placement language is a regulatory decision. The Federal Food, Drug, and Cosmetic Act defines a dietary supplement in section 201(ff)(2)(A)(i) as a product intended for ingestion. FDA has stated in warning letters that because sublingual products are intended to enter the body directly through the skin or mucosal tissues, they are not dietary supplements and are not foods, and has applied that reasoning to melatonin and other products with sublingual directions.

So a supplement strip should be labeled and marketed as a product that dissolves in the mouth and is swallowed. Directions to hold it under the tongue, and marketing that promises absorption through the mouth or bypassing digestion, move the product outside the supplement definition. A regulatory attorney interviewed by NutraIngredients in January 2026 said instructions and advertising must be controlled so the product is consumed and does not convey the benefits of sublingual administration.

We make orally dissolving strips intended for ingestion and do not write sublingual or buccal directions for supplement products. If a client's counsel reaches a different conclusion, that decision and its documentation belong to the client.

Packaging and stability

An oral film is a dry, hygroscopic sheet, and moisture is its main enemy. A published review describes fast-dissolving films as extremely sensitive to environmental moisture and puts shelf life at 2 to 3 years depending on the active. Humidity a capsule shrugs off will soften a strip, make it tacky in the sachet, or shift its dissolve time.

The answer is a barrier, and the barrier has a number. At the standard 38 °C and 90 % RH test condition, a 1 mil PET film passes 16–20 g of water vapor per square meter per day, LDPE 16–23, metallized PET roughly 0.5–1.0, and a laminate with a true aluminum foil layer about 0.005–0.006. That is why our standard primary pack is one strip per high-barrier PET/aluminum/PE heat-seal sachet, lot-coded, with no desiccant inside the sachet by default and secondary-pack desiccant only when a stability program shows a benefit. Thin foil carries pinholes (industry allowances run from hundreds per square meter at 7 μm down to zero at 25 μm), but a pinhole in the foil alone leaks very little through the polymer layers over it; the seal is the usual failure point, which is why seal integrity is checked on every lot.

Sachet structure, seal width, tear notch, print method and lot and expiration fields are agreed before the pilot, because a sachet that is hard to open or a seal that leaks turns a good film into a bad product. Cartons run from 10- to 60-count, with wallet, sample and AM/PM formats available at pilot scale, and certified child-resistant secondary packaging through packaging partners where law, channel or specification requires it. Cartons carry the Supplement Facts panel, directions, warnings and the structure/function disclaimer where claims are made. Small panels mean short copy, and artwork readiness is on the critical path.

Shelf life is not a number stated from memory. Our target is 24 months, subject to product-specific stability data. Stability programs use the ICH Q1A conditions, 40 °C and 75 % RH for six months accelerated and 25 °C and 60 % RH for twelve months long-term, and are scoped per project.

Testing and documentation

StripWorks does not hold cGMP, FDA registration, ISO or NSF certification today, and this page will not claim otherwise. What we can state is what the process includes and what a lot ships with.

Every lot is produced against an approved specification. Standard release controls on every lot: appearance, dimensions and weight, moisture or water activity where relevant, seal integrity and coding reconciliation, potency to the agreed finished-product specification, content uniformity where dose uniformity is material, and microbiological controls appropriate to the formula. Heavy metals, pesticides, residual solvents, allergen-specific testing, disintegration or dissolution, probiotic enumeration, specialized contaminant panels and formal accelerated or real-time stability are defined and quoted per project. Independent third-party analytical testing runs through ILS Lab, an accredited laboratory partner.

The framework these controls follow is 21 CFR Part 111, the federal cGMP rule for manufacturing, packaging, labeling and holding dietary supplements. The sections a buyer should see assigned in a scope document: 111.13, qualified supervisors over each operation; 111.35, written equipment, cleaning and calibration records; 111.70, specifications for components, in-process points, packaging, labels and finished product; 111.75, identity testing of dietary ingredients and finished-batch verification; 111.210, the master manufacturing record; 111.255, the batch production record; and Subpart O, complaint handling. FDA's 2016 quality-agreement guidance for drug contract manufacturing is a useful template for the division of duties: purpose and scope, definitions, dispute resolution, manufacturing activities, change control, and the agreement's life cycle, with business terms such as pricing kept out of it.

One point brands often miss: FDA's compliance guide to Part 111 says the firm that distributes a supplement under its own label is responsible for it, contract manufacturer or not, and must know what manufacturing activities were performed and how. Our documentation exists so that responsibility can be met.

Every released lot ships with a Lot Release Packet: the finished-product certificate of analysis, a certificate of conformance, lot and manufacturing identification, quantity reconciliation, packaging identification and the applicable third-party laboratory results. Raw-material certificates and additional quality documentation are available under the applicable quality agreement, and we retain the complete executed batch record for audit.

Private label vs. custom oral strips

Private label means a proven formula and format that a brand puts its own name on. White label is a ready-made formula sold to several brands under each brand's name. OEM means manufacturing to the buyer's specification. Custom means a formula built for one brand from a project-specific active system, dose and sensory target. None of these change the dosage form; they describe who is responsible for what. On the label the difference shows up as one line: under 21 CFR 101.5, a product not made by the company named must carry "Manufactured for" or "Distributed by" that company.

Private label is the right choice when a proven concept already fits the brand: a melatonin strip, a B12 strip, an energy strip. Development is limited to flavor preference, artwork and pack count, so the path to a pilot is shorter and the risk lower. Custom is the right choice when the active system, dose or positioning does not exist as a proven formula. It takes more time, because feasibility, formula and flavor work start from a brief rather than a base. Either way, the scope should state in writing who handles sourcing, artwork, packaging, testing, claims review, release decisions and the repeat-production specification.

Why the 500-box pilot exists

Most manufacturers quote a minimum in strips. We quote it in boxes, because boxes are what a brand sells, counts and forecasts. Five hundred 20-count boxes are about 10,000 strips; five hundred 30-count boxes are about 15,000 strips.

The pilot is sized to do three jobs. It is large enough to run the full production system, including casting, cutting, sachet sealing, carton packout, lot coding and documentation, so what the brand learns is about the real product. It is small enough that a brand can afford to learn: a flavor adjustment after 500 boxes is a revision, not a write-off. And it produces sellable inventory, so the pilot funds market feedback.

Qualified means the formula, ingredients, packaging, testing and production requirements have been confirmed as workable at that quantity. Raw-material minimums, printed-sachet minimums and testing scope can move the practical number for some projects, and we say so during scoping.

The pilot ends with a locked specification. The second run should be a production decision against the same formula, criteria and packaging, modeled at 1,000, 3,000 and 5,000 boxes before it is placed. A 5,000-box run is ten times the pilot, the same ratio FDA's SUPAC-IR drug guidance treats as a low-level change when equipment design, formulation, procedures and controls stay the same.

What StripWorks can formulate

From vitamins and minerals to branded botanicals, nootropics, probiotics, beauty-from-within ingredients, sports-nutrition actives and custom functional blends, we support more than 100 formulation starting points and fully custom oral-film development. High-load projects, premium branded ingredients, specialty packaging and market-specific formulations are scoped through the technical team.

Representative development targets from the current library: caffeine up to 80 mg; KSM-66 ashwagandha up to 250 mg; bacopa systems up to 160 mg; CoQ10 up to 150 mg; NMN up to 150 mg; collagen 100 mg; iron up to 27 mg elemental; L-citrulline 200 mg; LJ100 200 mg; probiotic systems of approximately 5–17 billion CFU input, strain dependent; melatonin 5 mg adult benchmark; zinc up to 10 mg adult benchmark; lion's mane 50 mg in the current mushroom-blend benchmark. All final doses remain formulation-, safety-, regulatory- and stability-dependent, and a development target is not a claim that a finished product has already been manufactured.

Common questions

Primary sources

• Orally dissolving strips: A new approach to oral drug delivery system (Int J Pharm Investig; PMC3757902)
• Orodispersible Films: Current Innovations and Emerging Trends (Pharmaceutics, 2023; PMC10747242)
• FDA Warning Letter: DK Vitamins, Feb 5, 2019 (sublingual products are not intended for ingestion)
• 21 U.S.C. 321(ff), definition of dietary supplement (Cornell LII)
• 21 CFR Part 111, cGMP for dietary supplements (Cornell LII)
• FDA: FDA 101: Dietary Supplements
• FDA: Is It Really FDA Approved?
• FDA: Structure/Function Claims
• FDA: Dietary Supplements overview
• FDA: Registration of Food Facilities and Other Submissions
• NutraIngredients, Jan 15, 2026: Compliance challenges rise with novel supplement delivery formats
• mdi Consultants: Orally disintegrating strips as dietary supplements
• 21 CFR 101.5, name and place of business of manufacturer, packer, or distributor (Cornell LII)
• FDA Small Entity Compliance Guide: cGMP for dietary supplements (own-label distributor responsibility)
• FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements (2016)
• 21 CFR 111.70, specifications; 111.75, testing (Cornell LII)
• Poly Print: Water vapor transmission rate of common films (38 °C, 90 % RH)
• CarePac: PET/AL/PE barrier laminates, WVTR and OTR
• TAPPI PLACE 2006, Murray: The Impact of Foil Pinholes and Flex Cracks on the Moisture and Oxygen Barrier of Flexible Packaging
• ICH Q1A(R2): Stability Testing of New Drug Substances and Products
• 16 CFR 1700.20, testing procedure for special packaging (Cornell LII)
• FDA SUPAC-IR: Immediate Release Solid Oral Dosage Forms, Scale-Up and Postapproval Changes (1995)

Build the next step around facts.

Tell us the active ingredients, target amount, flavor direction, formula status, pack count, first-run quantity, launch market, timing, and anything already decided. StripWorks will use the brief to map the most practical next step.