Saw Palmetto Men's Prostate Formula Capsules
Finished capsule · Serenoa repens fruit extract at 85-95% total fatty acids with phytosterols, nettle root and zinc
Finished capsule built on Serenoa repens fruit extract at 85-95% total fatty acids, with beta-sitosterol, nettle root, pumpkin seed and zinc. Softgel or vegan HPMC - shell origin fixed at order.
Specifications
| Format options | Softgel carrying saw palmetto oleoresin, or two-piece HPMC hard capsule filled with adsorbed 25% or 45% powder grade. Size and fill set to the buyer's label claim. |
| Shell origin - decide at order | Softgel gelatin is bovine, porcine or fish. Porcine blocks halal and kosher; fish gelatin is a declarable fish allergen. Vegan starch-carrageenan softgel and HPMC available. |
| Saw palmetto component | Serenoa repens (W. Bartram) Small (Arecaceae), synonym Sabal serrulata; ripe dried fruit, wild-harvested from the coastal southeastern United States. |
| Extraction and assay | Supercritical CO2, hexane or ethanol, fixed at order; residual solvents to ICH class limits. Total fatty acids 85-95% by GC-FAME; USP monograph minimum is NLT 80%. |
| Fatty acid and sterol profile | Typically lauric 27-30%, oleic 27-30%, myristic about 10%, palmitic about 10%; eleven acids quantified per USP. Native phytosterols under 1%, principally beta-sitosterol. |
| Adulteration control | Lauric-to-individual-fatty-acid ratios per the USP CO2 revision, plus acid value, fatty alcohol and sterol profiling. Screened for palm, palm kernel, coconut and canola oils. |
| Added phytosterol | Beta-sitosterol, CAS 83-46-5, C29H50O, MW 414.72, mp 136-140 C. Tall-oil (pine) derived by default; soy-derived sterol must be declared as soy - specify the source. |
| Nettle root, not leaf | Urtica dioica L. radix. Root and leaf are different articles with different constituents and prices; a specification reading only 'nettle extract' will deliver the wrong one. |
| Pumpkin seed and lycopene modules | Cucurbita pepo L. cold-pressed seed oil or 4:1 seed extract. Lycopene CAS 502-65-8, C40H56, MW 536.87; gelatin-matrix beadlets are bovine or fish - specify starch matrix. |
| Mineral actives and authorised claim | Zinc as bisglycinate or citrate, selenium as selenium yeast or sodium selenite. EU Reg. 432/2012 gives zinc the normal-blood-testosterone claim on significant-source terms. |
| Claim boundary | Food supplement. Wording touching lower urinary tract symptoms or benign prostatic hyperplasia is a medicinal claim in the EU, US and India and cannot go on this label. |
| Excipients and opacifier | Glycerol softgel plasticiser; MCC, colloidal silica and vegetable magnesium stearate in hard capsules. Titanium dioxide (E171) is no longer authorised in EU food. |
| Allergen, diet and origin status | No milk, egg, soy, crustacean, gluten, peanut or tree nut in the default build. Fish only if a fish-gelatin shell or gelatin beadlet is chosen. Vegan on the HPMC route. |
| Testing and shelf life | Assay, fatty acid profile, adulteration screen, heavy metals, pesticides and micro per lot. 24 months for hard capsules, 18 months for softgels, cool, dry, out of light. |
| HS code | 2106.90 (21069099) |
The active core of this finished capsule is saw palmetto, Serenoa repens (W. Bartram) Small (Arecaceae), the palm still traded under the synonym Sabal serrulata. The part used is the ripe dried fruit, wild-harvested from the coastal southeastern United States, extracted by supercritical carbon dioxide or by hexane or ethanol as specified at order, with residual solvents tested to the applicable ICH class limits. Thovek's standard oleoresin assays 85-95% total fatty acids by GC-FAME against a USP monograph minimum of not less than 80%, and the fatty acid distribution runs typically lauric 27-30%, oleic 27-30%, myristic around 10% and palmitic around 10%, with eleven individual acids quantified by the USP method. Phytosterols are present natively at a fraction of a percent, principally beta-sitosterol. This is one of the most adulterated articles in the botanical trade, so authenticity work is not optional: lauric-acid-to-individual-fatty-acid ratios per the USP revision for CO2 extracts, plus acid value, fatty alcohol and phytosterol profiling, screened against the documented substitution routes using palm, palm kernel, coconut and canola oils and synthetic free fatty acid blends. Where a dry hard-capsule fill is wanted rather than an oil, the oleoresin is supplied adsorbed on silicon dioxide or maize-derived maltodextrin at 25% or 45% total fatty acids, or as a 4:1 native ratio berry powder extract.
The co-actives are chosen for composition, and two of them carry declarations that decide what the finished label can say. Added phytosterol is beta-sitosterol, CAS 83-46-5, C29H50O, molecular weight 414.72, melting point 136-140 C, a hydrophobic plant sterol; the sourcing matters because commercial phytosterols come either from tall oil, a pine by-product, or from vegetable oil deodoriser distillate that is frequently soy. Thovek's default is tall-oil-derived so the finished capsule stays soy-free; a soy-derived sterol must be declared as soy under EU Annex II and US FALCPA. The nettle component must be specified as root, Urtica dioica L. radix, not leaf - root and leaf are different articles with different constituent profiles and different prices, and a specification that just says 'nettle extract' will get you the wrong one. Pumpkin seed, Cucurbita pepo L., is supplied as cold-pressed seed oil or as a 4:1 seed extract. Lycopene, CAS 502-65-8, C40H56, molecular weight 536.87, is offered as tomato oleoresin at 5-10% or as cold-water-dispersible beadlets, and here the beadlet matrix is the trap: a gelatin-matrix beadlet is bovine or fish in origin, so specify the modified food starch matrix if the pack has to stay vegan and fish-free. Zinc as bisglycinate or citrate and selenium as selenium yeast or sodium selenite complete the build; zinc carries an authorised EU nutrient function claim on the maintenance of normal testosterone levels in the blood under Commission Regulation (EU) No 432/2012, subject to the significant-source condition. Be clear about the claim boundary: this is a food supplement, and any wording touching lower urinary tract symptoms or benign prostatic hyperplasia is a medicinal claim in the EU, the US and India, and cannot be carried on a food supplement label.
The format decision is the single most consequential thing about this product, because saw palmetto oleoresin is an oil. A softgel is the natural carrier, and softgel shells are gelatin - bovine, porcine or fish. Porcine gelatin blocks halal and kosher certification outright; fish gelatin is a declarable fish allergen and the EU Annex II exemption for fish gelatine covers its use as a carrier for vitamin, carotenoid and flavouring preparations and as a fining agent, not a fish gelatine capsule shell. Vegan softgels built on modified maize starch and carrageenan are available and cost more. The alternative is a two-piece HPMC hard capsule filled with the adsorbed 25% or 45% powder grade, which keeps the article vegan end to end at the cost of a lower fatty acid load per capsule. Opaque shells for EU-bound stock use alternative opacifiers, since titanium dioxide (E171) is no longer authorised as a food additive in the EU. Glycerol is the softgel plasticiser; hard-capsule excipients are microcrystalline cellulose, colloidal silicon dioxide and vegetable-source magnesium stearate. Every batch ships with assay, fatty acid profile, adulteration screening, heavy metal, pesticide and microbiological data alongside allergen, GMO, vegan and gelatin-origin declarations, plus weight variation, disintegration and content uniformity to IP or USP method.
Applications
Men's health capsule rangesPrivate-label prostate formulasSoftgel contract manufacturingPharmacy own-label supplementsVegan capsule product linesSports and men's wellness stacksExport-ready dosage forms
Available grades
Saw palmetto as CO2 oleoresin at 85%, 90% or 95% total fatty acids, hexane or ethanol oleoresin at 85-90%, adsorbed powder at 25% or 45%, or 4:1 native ratio berry powder. Bovine, porcine, fish or vegan starch-carrageenan softgel shell, or vegan HPMC hard capsule in size 0 or 00. Optional beta-sitosterol, nettle root, pumpkin seed, lycopene, zinc and selenium modules. Halal, kosher and vegan certification on request, subject to the shell chosen.
Packaging: Bulk softgels or hard capsules in double food-grade LDPE liners inside 25 kg fibre drums or HDPE kegs with desiccant, nitrogen-flushed for oil-bearing fills. Retail options under a private-label agreement: 60, 90 or 120-count HDPE jars with induction seal and tamper band, or Alu-PVC and Alu-Alu blisters, printed to the buyer's artwork with batch coding and market-specific label text. Cartoned and palletised.