The Brief History of Gelatin in Soft Caps: Why Is It Still the Leading Choice for Manufacturers?

Gelatin has been the backbone of soft capsule manufacturing for decades. Despite new materials entering the market, it remains the top choice for its reliability, performance, and regulatory acceptance.

Origins of Gelatin Use in Soft Capsules

Early Pharmaceutical Capsule Innovations (19th–20th Century)

The journey of soft capsules began in the early 19th century when pharmacists sought better methods to deliver medicines orally. While hard gelatin capsules had already been introduced, innovators soon recognized the need for a seamless, hermetically sealed solution—especially for liquid or oil-based ingredients. Gelatin, derived from animal collagen, quickly emerged as the go-to material due to its gel-forming properties and ease of use in manufacturing.

Development of Softgel Technology (e.g., by R.P. Scherer in the 1930s)

A key milestone came in the 1930s when R.P. Scherer invented a rotary die process that revolutionized softgel production. This patented method uses gelatin to encapsulate liquids in a uniform, tamper-proof format, enabling precise dosage and extended shelf life. Scherer’s innovation laid the foundation for the mass production of softgels, which became widely adopted in both the pharmaceutical and nutraceutical industries.

Timeline of Key Developments:

1. Early 1800s – Hard gelatin capsules introduced for dry powders
    
2. 1930s – Rotary die softgel process invented by R.P. Scherer
    
3. 1950s–1970s – Softgels adopted for oil-based drugs and vitamins
    
4. 1980s–Present – Dominance in global pharma and supplement markets
    

Initial Reasons for Choosing Gelatin

Gelatin was not only readily available but also demonstrated superior film-forming capabilities, thermoreversibility (melting and setting), and biocompatibility. These properties made it ideal for creating soft capsules that were safe, effective, and easy for patients to swallow, long before synthetic alternatives entered the picture.

Functional Properties of Gelatin That Cemented Its Dominance

Gel-Forming and Thermoreversible Characteristics

One of gelatin’s most critical advantages lies in its natural gel-forming ability. When heated, gelatin dissolves into a liquid; when cooled, it solidifies into a stable yet flexible gel. This thermoreversible nature makes it ideal for encapsulating liquids or semi-solids without complex chemistry or synthetic additives.

Key benefits include:

• Reversible physical transformation (liquid ↔ gel)
   
• Consistent gel strength across batches
   
• No need for synthetic cross-linkers
   
• Easily adjustable viscosity for processing

Biocompatibility and Digestibility

As a naturally derived protein, gelatin is safe, non-toxic, and easily digested by the human body. Its long-standing use in pharmaceuticals is backed by decades of clinical and regulatory acceptance, making it a low-risk, high-reliability option for both drug delivery and dietary supplements.

Advantages in application:

• Naturally metabolized by digestive enzymes
   
• Minimal allergic reactions or sensitivities
   
• Supported by pharmacopeial monographs (e.g., USP, EP)
   
• Suitable for pediatric, geriatric, and general populations

As a trusted gelatin manufacturer, Funingpu gelatin meets stringent pharmaceutical-grade standards, providing safe and reliable solutions for capsule production worldwide.

Encapsulation Performance for Oils and Fat-Soluble Nutrients

Gelatin creates a seamless, airtight shell around oily or fat-soluble compounds like fish oil, vitamin D, or CBD. This not only prevents oxidation but also ensures consistent dosage and longer shelf life—benefits that plant-based materials still struggle to match.

Seal Integrity, Elasticity, and Stability in Manufacturing

During softgel production, gelatin offers excellent moldability and sealing properties. It produces capsules that are flexible yet strong, minimizing the risk of leaks, breaks, or deformation during transport or storage. These mechanical advantages are critical for large-scale, high-speed capsule production.

Manufacturing strengths:

• Rapid sealing under rotary die conditions
   
• Uniform wall thickness and capsule shape
   
• Tolerance to heat, humidity, and handling
   
• Fewer production defects or rejects

Evolving Industry Demands and the Role of Gelatin

Scale-Up for High-Volume Softgel Production

As global demand for supplements and medications in softgel form grew, manufacturers needed a material that could scale efficiently. Gelatin fit this need perfectly. Its compatibility with rotary die equipment and consistent performance across batch sizes made it ideal for high-throughput production without compromising capsule quality.

Regulatory Recognition and Global Compliance

Gelatin has earned widespread regulatory approval from agencies such as the FDA, EMA, and USP. This long-standing recognition simplifies compliance and product registration for manufacturers, especially when exporting to multiple countries. Few alternative materials can offer the same level of regulatory history and global trust.

Consumer Trust and Legacy in OTC Drugs and Supplements

From vitamins to cold medicine, consumers have grown accustomed to gelatin-based softgels. This familiarity builds trust and influences purchasing decisions. Many leading over-the-counter brands still rely on gelatin capsules—not only for functionality but also to maintain consumer confidence.

For manufacturers looking to scale efficiently while meeting international compliance standards, Funingpu gelatin delivers consistent quality and global-ready formulations tailored to the needs of pharmaceutical clients.

Challenges and Rising Alternatives

Vegetarian and Vegan Capsule Materials (HPMC, Pullulan)

With the rise of plant-based lifestyles and dietary restrictions, manufacturers have explored alternatives like hydroxypropyl methylcellulose (HPMC) and pullulan. These materials aim to mimic gelatin’s role while catering to vegetarian, vegan, kosher, and halal requirements. Though growing in popularity, they still represent a small share of the softgel market.

Market Push for Plant-Based Ingredients

Consumers are increasingly seeking clean-label and animal-free products, especially in the health and wellness sectors. This demand has led to innovations in capsule technology, including starch-based and alginate formulations. However, these materials often lack the same functional reliability as gelatin under industrial conditions.

Technical Limitations of Gelatin Alternatives

Many plant-based alternatives present challenges in capsule formation, such as lower elasticity, poor sealing properties, and increased sensitivity to temperature and humidity. These issues can lead to higher defect rates or the need for more complex manufacturing processes.

Cost, Availability, and Manufacturing Hurdles

Producing softgels from non-gelatin materials typically requires longer drying times and modified machinery, increasing both operational costs and production timelines. Moreover, plant-based raw materials may have more variable quality or limited sourcing options compared to gelatin, which benefits from a robust global supply chain.

As a trusted gelatin manufacturer, Funingpu gelatin supports pharmaceutical producers with consistent, high-grade gelatin backed by stable sourcing, cost-efficiency, and technical compatibility, minimizing risks and delays in large-scale production.

Why Gelatin Remains the Industry’s Leading Choice

Cost-Efficiency and Global Supply

Gelatin is cost-effective to produce at scale and benefits from a well-established global supply network. Whether sourced from bovine, porcine, or fish origins, manufacturers can secure reliable volumes with consistent quality, making it a practical choice for brands targeting both local and international markets.

As a global gelatin manufacturer, Funingpu gelatin offers scalable solutions tailored to pharmaceutical and nutraceutical producers seeking dependable, high-quality supply chains.

Superior Performance in Softgel Encapsulation

When it comes to performance, gelatin consistently delivers. It provides excellent capsule integrity, uniform thickness, fast sealing, and a smooth consumer experience. These technical benefits reduce production losses and quality control issues—key factors in large-scale operations.

Long-Term Regulatory Approval and Manufacturer Familiarity

Decades of use in FDA- and EMA-approved products give gelatin a strong regulatory advantage. Manufacturers are already equipped with processes and equipment tailored for gelatin, minimizing the learning curve, reducing compliance risk, and streamlining development timelines for new products.

Our pharmaceutical gelatin meets global regulatory standards and aligns with monographs from major pharmacopeias, helping clients ensure compliance in regulated markets.

Continuous Innovation in Gelatin Refinement

Leading gelatin suppliers have continued to improve their products, offering variants with lower endotoxin levels, enhanced clarity, and faster disintegration times. These innovations make gelatin even more competitive, particularly in pharmaceutical-grade applications where performance and safety are non-negotiable.

H2: Future Outlook of Gelatin in Soft Caps

Can Plant-Based Materials Catch Up?

Plant-based capsule materials are evolving, with improvements in machinability, moisture resistance, and shelf life. However, most still fall short of matching gelatin’s all-around performance in softgel applications. Until these gaps are fully closed, gelatin is likely to remain the preferred material for most manufacturers.

Sustainability Concerns and Gelatin Sourcing

Sustainability is becoming a key consideration in material selection. While gelatin is animal-derived, it is often produced as a byproduct of the meat industry, making it a form of upcycling. Transparency in sourcing, along with certifications like halal, kosher, or clean-label, helps manufacturers position gelatin-based products responsibly in eco-conscious markets.

Role of Gelatin in Emerging Delivery Systems

Gelatin is also proving adaptable to new markets such as CBD supplements, functional foods, and personalized medicine. Its ability to encapsulate oils, sensitive bioactives, or controlled-release compounds keeps it relevant in next-generation delivery systems. Innovations like fast-dissolving or enteric-coated gelatin capsules further expand its potential.

Final Thoughts

From its early pharmaceutical origins to its current dominance in both medical and wellness markets, gelatin has proven to be an unmatched material for soft capsule production. Its unique combination of functionality, cost-efficiency, safety, and scalability has kept it at the forefront, even in the face of rising plant-based alternatives.

While the demand for vegetarian capsules is growing, gelatin continues to offer superior performance in high-volume manufacturing and oil-based encapsulation. For manufacturers seeking a reliable, globally approved, and time-tested solution, gelatin remains the leading choice.

If you're looking for a dependable partner in pharmaceutical gelatin supply, Funingpu offers tailored solutions to meet your production, quality, and regulatory needs. Contact us today to explore how our gelatin can elevate your soft capsule formulations.