Seven chassis, one platform.
A unified lipid-formulation architecture across seven chassis — actives, co-surfactants, and a preservative — engineered to share the same delivery substrate. Liquid in, oral spray or transdermal out. The same CMC, the same supply chain, the same scientific spine.
7 CHASSIS – 8 VARIANTS – 3 PATENTS (FILED)
The platform, at a glance.
TAB. 01 . Comparison 29 APR 2026
| № 01 CHASSIS NAME | № 02 CHASSIS | № 03 CLASS | № 04 FORMAT / DELIVERY | № 05 PHARMACOLOGY / SAFETY | № 06 USE LEVEL | № 07 REG. PATHWAY | № 08 STAGE |
| Ibumix® № 01 | Sodium ibuprofen + lipid + water | NSAID · ACTIVE Standalone platform / Suspension vehicle. | → Liquid · oral / oral spray → Liquid · transdermal → Gel · cream | PKA / LOG P 4.4 / ~3.5 HALF-LIFE (ORAL) 1.8 – 2.0 h ADULT OTC CEILING 1,200 mg/day | 5 – 10% w/w topical, lead | FDA 505(b)(2) MHRA Art. 10(3) · IRP 60–150 wd | LEAD · 12–36 MO |
| Naproxymix® № 02 | Sodium naproxen + lipid + water | NSAID · ACTIVE Standalone platform / Suspension vehicle. | → Liquid · oral / oral spray → Liquid · transdermal → Once-daily gel · cream | PKA / LOG P 4.15 / 3.18 HALF-LIFE (ORAL) 12 – 17 h ADULT OTC CEILING 660 mg/day | 5 – 10% w/w topical, OD/BID | FDA 505(b)(2) MHRA Art. 10(3) · IRP 60–150 wd | SEQUENTIAL · 18–48 MO |
| Sorbymix® · 4 platforms | Polysorbate (Tween) family. Four standalone platforms. non-ionic POE-sorbitan fatty-acid esters + lipid + water | Standalone platform / solubiliser / emulsifier / Suspension vehicle— oral, topical, parenteral, ophthalmic. EXCIPIENT | → Liquid · oral / oral spray → Liquid · transdermal → Used in all platforms | JECFA GROUP ADI 25 mg/kg bw/day EFSA NOAEL (RAT) 2,500 mg/kg/day FDA-IID listed (oral, topical, parenteral) | 1.0 – 8.4% w/w cap PS-80 ≤ 2% | FDA-IID excipient EMA 2018 polysorbate guidance | ESTABLISHED |
| Sorbymix 20 № 03 | Standalone platform. PS-20 · Tween 20 · monolaurate · C12 + lipid + water | Solubiliser, oral & topical | 0.02 – 66 mg/dose oral | Standard component, vet oral suspensions | |||
| Sorbymix 40 № 04 | Standalone platform. PS-40 · Tween 40 · monopalmitate · C16 + lipid + water | Emulsifier, food-grade GRAS | Low % topical | 21 CFR 172.836 · niche vet topicals | |||
| Sorbymix 60 № 05 | Standalone platform. PS-60 · Tween 60 · monostearate · C18 + lipid + water | O/W emulsion stabiliser | 0.5 – 5% topical | Cream architecture; vet pastes | |||
| Sorbymix 80 № 06 | Standalone platform. PS-80 · Tween 80 · monooleate · C18:1 + lipid + water | Solubiliser; LD₅₀ rat 2.9–39.8 g/kg | Oral max ≈ 350 mg/day | Licensed vet injectables & vaccines |
| Cinnamix® № 07 | Potassium cinnamate + lipid + water· GRAS (FEMA 1965 · JECFA 657) | Standalone Platform / Suspension vehicle. PRESERVATIVE · ANTI-MICROBIAL | → Liquid · oral / oral spray → Liquid · transdermal → Used in all platforms | JECFA TEMP. ADI 0 – 0.7 mg/kg bw/day CINNAMIC ACID LD₅₀ (RAT) ~ 2.5 – 3.5 g/kg GENOTOX / AMES negative | 0.2 – 0.4% w/w at pH 4.5 – 6.5 | GRAS · FDA EU additive · feed cleared | ESTABLISHED |
† All values from primary regulatory or compendial sources (FDA, MHRA / eMC SmPC, EMA, JECFA, FDA Inactive Ingredient Database) as of 29 April 2026. Doses for orientation only; the Sponsor’s CMC dossier and clinical protocol must restate them with the specific reference cited at submission. ‡ Sodium-NSAID platforms (Ibumix, Naproxymix) are NOT licensed for any companion-animal species in UK / EU / USA and are contraindicated in dogs and cats.
Per chassis, in detail.
Spec Sheet – 01
Ibumix®
№ 01 · Sodium Ibuprofen + Lipid + water
The lead chassis. Lowest-risk, fastest to market.
The platform’s validation vehicle.
KEY PARAMETERS
CHASSIS Sodium ibuprofen + Lipid + Water
PKA 4.4
LOG P ~ 3.5
ORAL T½ 1.8 – 2.0 h
TOPICAL % 5 – 10% w/w
LEAD TIME 12 – 36 months
WHY THIS IS THE LEAD
Sodium ibuprofen + Lipid sits squarely within the precedent set by the licensed 5% and 10% ibuprofen topical gels already on the UK and EU markets. The sodium-salt rate-controls release into the vehicle; lipid rate-controls flux across the stratum corneum. Both worlds, by design.
DOSE & EXPOSURE
ADULT OTC
1,200 mg/day (UK BNF, MHRA SmPC) · Rx up to 2,400 mg/day
PAEDIATRIC
5 – 10 mg/kg q6–8h · ceiling 40 mg/kg/day or 2,400 mg/day · ≥ 3 months
TOPICAL (PER APP.)
~ 4 g product (≈ 200 mg sodium ibuprofen at 5% w/w) · up to 4×/day
DAILY TOPICAL
~ 5% of oral OTC ceiling — well within tolerability claims
FORMAT-BY-FORMAT FIT
CREAM (O/W)
Strong · Lipid in oil phase, sodium ibuprofen in water phase, PS-60 stabilises · paediatric/elderly tolerated
HYDROALCOHOLIC GEL
Strong · matches existing 5–10% gel category · fast-drying · consumer-preferred
METERED SPRAY
Good · 3–5% Lipid · hand-free · sport / inflamed skin · device validation
LIQUID ROLL-ON
Good – simplest engineering – cheapest to manufacture – OTC friendly
REGULATORY PATHWAY
USA · FDA
505(b)(2) NDA referencing listed 5% topical ibuprofen · PK bridging study · 30–36 mo post Pre-IND
UK · MHRA
Hybrid Article 10(3) · comparator: Ibuleve Max / Ibugel Forte SmPC · IRP 60–150 wd
EU · EMA
Hybrid centralised or DCP/MRP · polysorbate excipient labelling above thresholds
COMPANION-ANIMAL WARNING
NOT licensed for dogs, cats or food-producing species. Toxicity ≥ 50 mg/kg in dogs, ≥ 25 mg/kg in cats. Topical packaging carries pet-safety labelling and bittering agent in cream/gel.
Spec sheet – 02
Naproxymix®
№ 02 · Sodium Naproxen + Lipid + Water
The long-acting cousin. A once- or twice- daily topical, sequenced behind the lead.
KEY PARAMETERS
CHASSIS Sodium naproxen + Lipid
PKA 4.15
LOG P 3.18
ORAL T½ 12 – 17 h
TOPICAL % 5 – 10% w/w
LEAD TIME 18 – 48 months
WHY NAPROXEN, WHY NOW
Long systemic half-life plus high water-solubility of the sodium salt is the classic platform for a once- or twice-daily transdermal product. The local cutaneous-tissue accumulation observed in 5–10% naproxen gel PK studies (1.0–2.1% systemic bioavailability) supports a meaningful local pharmacological effect with fewer applications per day than ibuprofen.
DOSE & EXPOSURE
ADULT OTC
660 mg/day (US Aleve®, UK Feminax Ultra®, ≥ 12 yrs) · Rx 1,100–1,500 mg/day
PAEDIATRIC
20 mg/kg/day in two divided doses · ceiling 1,000 mg/day Rx · OTC ≥ 12 yrs only
TOPICAL (PER APP.)
~ 4 g product (≈ 200 mg sodium naproxen at 5% w/w) · 1–2×/day
DAILY TOPICAL
< 10% of oral OTC ceiling
FORMAT-BY-FORMAT FIT
CREAM (O/W)
Strong · same architecture as Ibumix · BID dosing aligned with chronic OA adherence
HYDROALCOHOLIC GEL
Strong · existing 5–10% gel precedent · long-acting, low-frequency · skin-stain studies needed > 5%
METERED SPRAY
Moderate · higher EtOH fraction · once-daily · elderly with grip difficulty
LIQUID ROLL-ON
Good · simplest · lowest cost-of-goods · clothing-staining risk
REGULATORY PATHWAY
USA · FDA
505(b)(2) NDA referencing 5.5% naproxen sodium gel where available · 36–48 mo
UK · MHRA
Hybrid Article 10(3) · fewer ready UK comparators · fuller PK + tolerability dataset
EU · EMA
Hybrid · long-acting profile fits elderly OA · paediatric investigation plan if EU strategic
COMPANION-ANIMAL WARNING
NOT licensed for dogs or cats. More toxic than ibuprofen — signs at ≥ 5 mg/kg in dogs, t½ 35–74 h. Black-box-equivalent consumer pack warning required.
Spec Sheet – 03
Sorbymix®
№ 03 · Polysorbate (Tween) family · 4 variants + Lipid + Water
The co-surfactant chassis. Four chain lengths, one shared safety dossier. Standalone platform.
KEY PARAMETERS
FAMILY Tween 20 / 40 / 60 / 80
GROUP ADI 25 mg/kg bw/day
EFSA NOAEL 2,500 mg/kg/day (rat)
FDA-IID listed (oral, topical, parenteral)
TOPICAL % 1.0 – 8.4%
PS-80 ORAL MAX ≈ 350 mg/day
THE VARIANTS, BY FATTY-ACID CHAIN
SORBYMIX 20
PS-20 · monolaurate · C12. Solubiliser. Common in vet oral suspensions and injectables. JECFA group ADI 25 mg/kg/day.
SORBYMIX 40
PS-40 · monopalmitate · C16. Direct food additive (FDA 21 CFR 172.836). Niche use in vet topicals; food-grade GRAS.
SORBYMIX 60
PS-60 · monostearate · C18. Cosmetic / topical excipient at 0.5–5%. Used in vet creams and oral pastes. Lead emulsion stabiliser for our cream architecture.
SORBYMIX 80
PS-80 · monooleate · C18:1. The workhorse: FDA-IID oral max ≈ 350 mg/day, topical up to 8.4%. Licensed in vet injectables, oral suspensions, vaccines (adjuvant). LD₅₀ rat 2.9–39.8 g/kg.
FUNCTION IN THE PLATFORM
Sorbymix variants are standalone platforms.
REGULATORY ANCHORS
FDA
CPG Sec. 555.800 · IID listed for oral, ophthalmic, topical, parenteral · 21 CFR 172.836
EMA
2018 polysorbate excipient guidance · mandatory PIL wording above per-day threshold
JECFA
Group ADI 25 mg/kg bw/day across PS-20/40/60/80
EFSA
Chronic-rat NOAEL 2,500 mg/kg/day for the polysorbate group
HYPERSENSITIVITY FLAG · PS-80
Oral PS-80 is well tolerated, but parenteral and high-dose topical PS-80 has been associated with rare anaphylactoid and contact-urticaria reactions. EMA mandates labelling above defined thresholds. Platform rule: cap PS-80 ≤ 2% w/w; consider PS-60 for chronic-use cream products.
Spec Sheet – 04
Cinnamix®
№ 04 · Potassium Cinnamate + Lipid + Water
Standalone Chassis (preservative). GRAS, food-grade, antimicrobial.
KEY PARAMETERS
CHASSIS Potassium cinnamate + lipid
JECFA TEMP. ADI 0 – 0.7 mg/kg bw/day
CINNAMIC ACID LD₅₀ ~ 2.5 – 3.5 g/kg (rat)
GENOTOX / AMES negative
IN-FORMULATION % 0.2 – 0.4% w/w
WORKING pH 4.5 – 6.5
WHAT IT DOES, WHAT IT IS
Potassium cinnamate is a functional preservative and antimicrobial — GRAS in the US (FEMA 1965), JECFA No. 657, with food usage at 0.1–0.5% — applied in our platform at 0.2–0.4% within a working pH of 4.5–6.5. Cinnamic acid is permitted as flavouring in animal feed across EU additive registers; non-mutagenic Ames-negative profile.
ROLE ACROSS THE PLATFORM
IN IBUMIX
Preservative for water-phase cream / gel · paired with sodium ibuprofen at pH 4.5–6.5
IN NAPROXYMIX
Same preservative system; lead format = once-daily gel
WITH SORBYMIX
Compatible with PS-60 / PS-80 emulsions; no known incompatibilities at use levels
STANDALONE
Available as oral spray / transdermal vehicle when API-free preservation is required
REGULATORY ANCHORS
USA · FDA
GRAS · FEMA 1965 · cosmetic / food usage cleared
EU · EFSA
Cosmetic and food usage acceptable within EFSA limits
JECFA
No. 657 · temporary ADI applied to cinnamic-acid family at 0–0.7 mg/kg bw/day
PRESERVATIVE CHALLENGE
Potassium cinnamate at 0.2–0.4% in pH 4.5–6.5 is a credible system. Where USP <51> challenge requires reinforcement, combine with potassium sorbate or sodium benzoate; full preservative effectiveness programme runs alongside accelerated stability.