{"id":19150,"date":"2026-06-17T17:24:57","date_gmt":"2026-06-17T10:24:57","guid":{"rendered":"https:\/\/www.tibdglobal.com\/product\/softgel-stability\/"},"modified":"2026-10-01T15:25:13","modified_gmt":"2026-10-01T08:25:13","slug":"softgel-stability","status":"publish","type":"product","link":"https:\/\/www.tibdglobal.com\/en\/product\/softgel-stability\/","title":{"rendered":"Softgel and Soft Lozenge Stability Testing Service"},"content":{"rendered":"
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Softgel capsules (Soft Gelatin Capsules) and Soft Lozenges are dosage forms that combine a liquid or semi-solid fill with a flexible outer shell, creating a product format that is highly sensitive to temperature, humidity, and oxidation conditions. Under the hot and humid environment of ASEAN Zone IVb, Softgel shells are prone to softening and stickiness at high humidity, brittleness and cracking at low humidity, and gelatin cross-linking from aldehyde compounds formed during lipid oxidation in the fill. Omega-3 fish oil, krill oil, linseed oil, herbal extracts in oil carriers, and fat-soluble vitamins enclosed in Softgel capsules are all subject to oxidative degradation characterized by Peroxide Value (PV), Anisidine Value (AnV), and TOTOX index monitoring throughout the shelf life.<\/p>\r\n

TIBD’s service is designed specifically for Softgel Capsules and Soft Lozenges, covering Shell Integrity assessment, Hardness by Texture Analyzer, Brittleness Drop Test, Disintegration Time, Fill Weight and Content Uniformity, Moisture Content, Peroxide Value (PV) per AOCS Cd 8b-90, Anisidine Value (AnV) per AOCS Cd 18-90, TOTOX index, Active Ingredient Assay by HPLC and GC-FID, Cross-linking assessment by Two-Tier Dissolution per USP Apparatus 1 in pepsin medium and by FTIR, and Microbiology including TSE Certificate verification, Heavy Metal, Pesticide Residue, and Persistent Organic Pollutants (POPs) for Fish Oil products under ASEAN Zone IVb conditions per ICH Q1A(R2) and ICH Q1B Photostability, in partnership with VISBIO as an Independent Quality Assurance Verifier (IQAV) using Validated Methods per ICH Q2(R1).<\/p>\r\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t

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<\/span>Softgel and Soft Lozenge Product Types in the Thai and ASEAN Market<\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=”” woodmart_inline=”no” text_larger=”no”]\r\n

Seven product types covering the main Softgel and Soft Lozenge formats are commercially produced in Thailand and the ASEAN region.<\/p>\r\n\r\n

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  • Omega-3, Krill Oil, and Linseed Oil Softgels are produced by encapsulating polyunsaturated fatty acid oils from fish, krill, or flaxseed in a gelatin shell. These products are among the highest-volume softgel products in the Thai and ASEAN market and require monitoring of EPA and DHA content by GC-FID per AOCS Ce 1i-07, Peroxide Value, Anisidine Value, and TOTOX index throughout the shelf life to confirm that the oil quality remains within GOED Monograph limits: PV not more than 10 mEq\/kg, AnV not more than 20, and TOTOX not more than 26.<\/li>\r\n \t
  • Herbal Extract in Oil Softgels encapsulate lipid-soluble herbal extracts or CO2 supercritical extracts in oil carriers such as Olive Oil, MCT (Medium Chain Triglyceride) Oil, or Sunflower Oil. Products include Turmeric (Curcuminoids), Black Pepper (Piperine), Copaiba (Beta-Caryophyllene), and herbal essential oil extracts. Active Ingredient Assay by HPLC monitors both the active and the carrier oil oxidation status.<\/li>\r\n \t
  • SEDDS (Self-Emulsifying Drug Delivery System) Softgels encapsulate an oil-surfactant-co-surfactant mixture that self-emulsifies upon contact with gastrointestinal fluids, providing improved bioavailability for poorly water-soluble herbal actives. SEDDS formulations are particularly sensitive to polymer precipitation and crystallization during storage, which must be monitored by Dissolution testing at each Pull Point.<\/li>\r\n \t
  • Vitamin E, Vitamin K2, and Fat-Soluble Vitamin Softgels are produced by dissolving fat-soluble vitamins in a carrier oil at defined concentrations. Vitamin E (d-alpha-Tocopherol and mixed Tocopherols) and Vitamin K2 (MK-7 form) require monitoring by Fluorescence HPLC due to their sensitivity to oxidative and photolytic degradation.<\/li>\r\n \t
  • Children Soft Candy Lozenge products are soft, chewable dosage forms for pediatric vitamin and herbal supplement delivery. These products use gelatin or Pectin as the base, sugar or sugar alcohols as plasticizers and sweeteners, and natural flavors and colors. Stability testing covers Hardness by Texture Analyzer, Moisture Content, Water Activity, and Vitamin Assay.<\/li>\r\n \t
  • Gummy Lozenge products are high-sugar or sugar-free gummy formats produced from gelatin or Pectin base with Corn Syrup or Isomalt as humectant. These products are susceptible to moisture loss causing texture hardening, moisture absorption causing stickiness, and color and flavor degradation.<\/li>\r\n \t
  • Functional Soft Lozenge products include CoQ10 Softgel, Astaxanthin Softgel, Lutein and Zeaxanthin Softgel, and other functional ingredient softgels for the health supplement market. Active Ingredient Assay, Isomer Ratio monitoring, and oxidation status monitoring are required for all these product types.<\/li>\r\n<\/ul>\r\n[\/vc_column_text][vc_single_image image=”19009″ img_size=”full” alignment=”center” css=”” parallax_scroll=”no” woodmart_inline=”no”][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t
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    <\/span>Specific Stability Challenges of Softgels and Soft Lozenges in Tropical Climates<\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=”” woodmart_inline=”no” text_larger=”no”]\r\n

    Seven stability challenges specific to Softgel Capsules and Soft Lozenges must be addressed in a protocol designed for ASEAN Zone IVb conditions.<\/p>\r\n\r\n

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    1. The first challenge is shell softening, tackiness, and deformation at high temperature and humidity. Gelatin softgel shells contain Glycerin as plasticizer, which absorbs moisture from the environment at high relative humidity, causing the shell to become excessively soft, sticky, and prone to deformation and capsule-to-capsule adhesion. Shell Hardness by Texture Analyzer and visual assessment of tackiness are conducted at each Pull Point.<\/li>\r\n \t
    2. The second challenge is shell brittleness and cracking at low relative humidity. When stored in dry conditions (below 30% RH), the gelatin shell loses plasticizer moisture and becomes brittle, forming cracks that allow the fill to leak. Brittleness is assessed by Brittleness Drop Test: capsules are dropped from 1 meter height and examined for cracking or leakage.<\/li>\r\n \t
    3. The third challenge is gelatin cross-linking causing shell dissolution failure. Aldehydes formed from oxidation of polyunsaturated fatty acids in the fill react with the Amino Groups of the gelatin shell in a cross-linking reaction, forming covalent bonds that render the shell insoluble. Cross-linking is detected by Disintegration Time exceeding twice the initial value. It is confirmed by Two-Tier Dissolution testing per USP Apparatus 1 (Basket) in 0.1 M HCl with pepsin (simulating gastric digestion) for Stage 1, followed by phosphate buffer pH 6.8 without enzyme for Stage 2. Cross-linked shells fail Stage 1 Dissolution in pepsin medium. Cross-linking is confirmed structurally by FTIR spectroscopy showing characteristic Maillard or Schiff base absorption bands.<\/li>\r\n \t
    4. The fourth challenge is oil oxidation in the fill. Peroxide Value (PV) reflects primary oxidation products (Hydroperoxides). Anisidine Value (AnV) reflects secondary oxidation products (Alkenals and Dienals). TOTOX index (TOTOX = 2 \u00d7 PV + AnV) is the combined oxidation index per GOED Monograph: PV not more than 10 mEq\/kg, AnV not more than 20, TOTOX not more than 26. Once these values exceed the GOED limits, the product is considered unfit for consumption regardless of the declared shelf life.<\/li>\r\n \t
    5. The fifth challenge is active ingredient degradation in the fill. Astaxanthin, CoQ10, Vitamin D3, Curcuminoids, EPA, and DHA all degrade under oxidative conditions accelerated by the elevated temperature of ASEAN Zone IVb storage. Active content must be maintained at Not Less Than 90% of the labeled value throughout the shelf life.<\/li>\r\n \t
    6. The sixth challenge is moisture absorption and texture change in Soft Lozenges. Gummy and soft candy lozenges absorb moisture at high humidity causing stickiness and shape loss, or lose moisture at low humidity causing hardening. Texture Profile Analysis (TPA) by Texture Analyzer measures Hardness, Gumminess, and Cohesiveness at each Pull Point.<\/li>\r\n \t
    7. The seventh challenge is flavor and color degradation in Soft Lozenges and flavored Softgels. Natural flavors and colors derived from fruits, vegetables, and herbal extracts are sensitive to heat and light. Color assessment by CIE La<\/em>b* Colorimetry and sensory evaluation at each Pull Point document the color and aroma stability throughout the shelf life.<\/li>\r\n<\/ol>\r\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t
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      <\/span>Testing Parameters: Shell Integrity, Hardness, PV, AnV, TOTOX<\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=”” woodmart_inline=”no” text_larger=”no”]\r\n

      TIBD’s stability testing protocol for Softgel Capsules and Soft Lozenges covers the full set of physical, chemical, and microbiological parameters.<\/p>\r\n\r\n