Common Pitfalls in Softgel Production and How to Fix Them

Softgel capsules are one of the most commonly seen dosage forms in the nutraceutical industry. They are popular because they are easy to swallow, offer better absorption, and help deliver oils, vitamins, and fat-soluble nutrients effectively. However, softgel production is a technical process, and even small mistakes can lead to quality issues, wastage, and regulatory problems.

Many nutraceutical brands face challenges in softgel manufacturing due to formulation errors, poor raw materials, or weak quality control systems. Understanding these common pitfalls and knowing how to fix them is essential for producing safe, stable, and market-ready softgel products.

Poor Shell Composition and Gelatin Quality

One of the most common problems in softgel production is improper shell formulation. The softgel shell must be flexible, strong, and stable.

Common issues include:

• Shell cracking or leaking
• Sticky or brittle capsules
• Uneven shell thickness

These problems usually occur due to low-grade gelatin, incorrect plasticizer ratio, or poor temperature control during processing.

How to fix it:

• Use pharmaceutical or food-grade gelatin only
• Maintain the correct balance of gelatin, plasticizer, and water
• Control drying temperature and humidity carefully

Working with a reputable nutraceutical manufacturer helps ensure that shell composition follows standardized quality norms and testing protocols.

Fill Material Incompatibility

Another major pitfall is incompatibility between the fill material and the softgel shell. Some oils, extracts, or active ingredients may react with gelatin or weaken the shell over time.

This can result in:

• Shell softening
• Leakage during storage
• Reduced shelf life

How to fix it:

• Conduct compatibility studies before finalizing the formulation
• Use suitable antioxidants or stabilizers when required
• Avoid ingredients known to migrate into gelatin shells

Pre-formulation testing is essential to prevent long-term stability issues.

Inconsistent Capsule Weight and Dosage

Uniformity in capsule weight and fill volume is critical in nutraceutical production. Inconsistent dosage can lead to regulatory non-compliance and loss of consumer trust.

Common causes include:

• Improper machine calibration
• Variation in fill viscosity
• Inadequate process monitoring

How to fix it:

• Calibrate encapsulation machines regularly
• Maintain consistent viscosity of fill material
• Perform in-process checks at fixed intervals

Strict quality checks ensure every capsule meets label claim requirements.

Air Entrapment and Bubble Formation

Air bubbles inside softgel capsules affect appearance, stability, and sometimes dosage accuracy. This problem usually occurs during mixing or filling.

Effects include:

• Capsule deformation
• Increased oxidation risk
• Lower product stability

How to fix it:

• Use vacuum mixing systems
• Allow proper deaeration before encapsulation
• Avoid high-speed agitation that traps air

Careful handling during formulation preparation is key to avoiding this issue.

Improper Drying and Moisture Control

Drying is one of the most critical stages in softgel manufacturing. Excess moisture can cause stickiness, while over-drying can make capsules brittle.

Problems caused by poor drying include:

• Capsules sticking together
• Shell cracking during storage
• Reduced shelf life

How to fix it:

• Maintain controlled temperature and humidity
• Follow validated drying timelines
• Monitor moisture content regularly

Environmental control systems play a vital role in consistent drying outcomes.

Oxidation of Fill Ingredients

Many softgel formulations contain oils, omega fatty acids, or fat-soluble vitamins that are sensitive to oxidation. Oxidation reduces potency and causes an unpleasant odor or taste.

Signs of oxidation include:

• Rancid smell
• Color change
• Reduced efficacy

How to fix it:

• Use antioxidants such as vitamin E where appropriate
• Minimize exposure to light, heat, and oxygen
• Use protective packaging like blister packs or amber bottles

Oxidation control is essential for product stability and consumer satisfaction.

Weak Quality Control and Testing

Skipping or reducing quality testing is a serious mistake in softgel production. Without proper testing, defects may go unnoticed until products reach the market.

Key testing areas include:

• Weight variation
• Disintegration time
• Leak test
• Stability studies

How to fix it:

• Follow defined SOPs for quality control
• Perform batch-wise testing
• Maintain proper documentation

WHO emphasizes that quality assurance systems are critical for health product safety and consumer trust [1].

Regulatory Non-Compliance

Nutraceutical products must comply with national regulations related to labeling, ingredients, and safety. Non-compliance can lead to recalls, penalties, or brand damage.

Common compliance issues include:

• Incorrect label claims
• Use of unapproved ingredients
• Missing stability data

How to fix it:

• Follow FSSAI and applicable guidelines
• Ensure documentation is complete
• Work with experienced regulatory teams

WHO and related authorities stress that compliant manufacturing systems protect both consumers and businesses [2].

Choosing the Wrong Manufacturing Partner

One of the biggest long-term pitfalls is choosing an inexperienced or poorly equipped manufacturer. This can lead to repeated quality failures and supply disruptions.

How to fix it:

• Select manufacturers with proven softgel expertise
• Verify certifications and quality systems
• Review past production capability and testing standards

Partnering with a reliable manufacturer ensures consistent output and long-term brand stability [3].

Final Thoughts

Softgel production offers excellent opportunities in the nutraceutical market, but it also requires technical precision and strong quality systems. Most problems arise from avoidable issues such as poor formulation planning, weak process control, or a lack of testing. By identifying these pitfalls early and applying corrective measures, brands can improve product quality, reduce wastage, and build long-term trust.

If you want to avoid these challenges and ensure smooth production, it is wise to contact the best nutraceutical manufacturer in India and work with experts who understand softgel technology deeply.

To explore more, you can also check our group websites: Zoicayurveda for 3rd party Ayurvedic and herbal cosmetic manufacturing, Biozoc for allopathic and drug PCD franchise opportunities, and Zocveda for Ayurvedic and herbal PCD franchise solutions.

Frequently Asked Questions

1. Why are softgels difficult to manufacture?
   They require precise control of formulation, temperature, humidity, and machinery.
2. What causes softgel leakage?
   Poor shell quality, incompatible fill materials, or incorrect drying.
3. How can oxidation be prevented in softgels?
   By using antioxidants and protective packaging.
4. Are quality tests mandatory for softgels?
   Yes, they are essential for safety and compliance.
5. Can startups manufacture softgels safely?
   Yes, by partnering with experienced third-party manufacturers.
6. Do softgels have a shorter shelf life?
   Not if properly formulated and stored.

Medical Disclaimer

This content is for general informational purposes only and does not constitute medical or nutritional advice. Always consult a qualified healthcare professional before using any nutraceutical product.

References

[1] World Health Organization – Quality Assurance of Health Products
[2] WHO Guidelines on Nutritional Supplement Safety
[3] International Standards for Nutraceutical Manufacturing