INTRODUCTION:

The word 'Capsule' is derived from the Latin term 'Capsula', meaning a small box or container. Capsules are categorized into hard (two-piece) and soft (one-piece) types, and they are designed to hold medicinal formulations. A capsule is composed of a cap that fits over an open body piece, forming a closed cylindrical structure. While capsules are predominantly administered orally, they can also be utilized for inhalation (as seen with Spiriva HandiHaler), vaginal (such as Gyno-Daktarin), and rectal routes. Recently, HPMC tablets have emerged for powdered herbs and dietary supplements, alongside the majority of prescription drugs that are gelatin-based. The choice of capsule-based medications by patients may be affected by various religious, cultural, or personal considerations. HPMC capsules present a commendable alternative to gelatin capsules due to their vegetable origin. An increasing number of companies are opting for vegetarian capsules in their medication packaging. Although the majority of capsule users do not concern themselves with the origin of their medication, there are some who do. To guarantee the safety and natural integrity of the capsules, a complete transition is the most effective approach. Typically, vegetable capsule shells are produced from hydroxypropyl methylcellulose (HPMC), also referred to as Hypromellose. This chemically altered cellulose is considered safe for human intake and can serve as a coating polymer, bioadhesive, thickening agent in controlled release systems, solid dispersion to improve drug solubility, and as a binder.¹

What is vegetable capsule?

Vegetable capsule, also known as vegetarian capsule or veggie capsule, are a type of capsule made from plant derived materials. They are designed to replace traditional gelatin capsules, which are derived from animal products.¹ Vegetable capsule have gained popularity in recent years, due to growing demand for vegetarian and vegan products. They offer a suitable alternative for individuals who follow a plant based diet or prefer to avoid animal derived products.²

The use of vegetable capsules have become increasingly widespread in various industries, including dietary supplements, pharmaceuticals, and cosmetics. They are available in various size and shapes, and can be customized to meet specific requirements. Vegetable capsules are also biodegradable and compostable, making them attractive option for companies looking to reduce their environmental footprint.³

Why to use Vegetable Capsules?

Religious, cultural, and personal factors may influence patients' preferences regarding medications offered in capsule form. The consumption of gelatin from particular beast may be interdicted by religious or artistic customs. Vegetarians and vegan choose not to eat foods containing gelatin made from beast gelatin with material made obtained by extracting collagen from fish bones.4

Some more advantages of vegetable capsule over gelatin capsule:

1. Vegetable capsule are less likely to cause allergic reactions compared to gelatin capsules.

2. Vegetable capsule are easily to digest then gelatin capsule, making them ideal for individual with digestive issues.

3. Vegetable capsules can enhance the bioavailability of active ingredients, leading to improved efficacy.

4. Vegetable capsules are certified by Halal and Kosher, making them suitable for consumers.

5. Vegetable can improve stability for sensitive ingredients, such as probiotics and enzymes.⁵

Polymers Used in Vegetable Capsule:

1. Hydroxy propyl methyl cellulose (HPMC) capsule shell.

2. Pullulan capsule shell.

3. Starch capsule shell.

4. Poly vinyl alcohol capsule shell.

5. Alignate capsule shell.

Hydroxy Propyl Methyl Cellulose (HPMC) capsule shell:

HPMC vegetarian capsules, also referred to as polymer capsules, are made from natural polymers and fibers. They are primarily derived from Hydroxy Propyl Methyl Cellulose, commonly known as hypromellose.⁶ This substance is created through the synthetic modification of the naturally occurring polymer cellulose and is deemed safe for regular human consumption. Polymer capsules have the ability to postpone the release of medication from the capsule shell, which may render them advantageous for time-delayed release applications. These empty shells contain active pharmaceutical ingredients in dry or liquid form. Dry capsules are filled with powder, while liquid or semi-solid capsules may be filled with liquid.⁷

HPMC functions as a coating polymer, bioadhesive, and thickening agent within controlled release systems. It is also applicable in solid dispersion to enhance drug solubility. This compound is characterized as a white to slightly off-white powder or granules that are largely insoluble in hot water, acetone, dehydrated ethanol, and chloroform, yet it dissolves in cold water, creating a colloidal solution due to its reversible thermal gelation property. HPMC is offered in various types, with restrictions on methoxy and hydroxyl propoxy groups.⁸ HPMC is classified as GRAS, indicating it is generally recognized as safe by the FDA. In the pharmaceutical sector, HPMC serves as a film coating and as a component in sustained-release tablets.⁹

HPMC capsules are designed for application in both pharmaceutical products and dietary supplements. Shionogi Qualicaps developed QUALI-V, the inaugural HPMC capsule intended for medicinal use.¹⁰ In 1989, G.S. Technologies Inc. (currently part of R.P. Scherer Technologies) produced the first vegetable capsules branded as Vegicaps, which are composed of HPMC.

Fig.1 Chemical structure of HPMC²⁷

The manufacturing process of HPMC-based capsules necessitates specific modifications to the molding apparatus or the formulation of the shell materials. In contrast to gelatin solutions, HPMC gels when the temperature is elevated and reverts to its original solution state upon cooling. Consequently, the pins immersed in the dip pan containing the HPMC solution must be maintained at an elevated temperature of 70°C to facilitate film formation. Furthermore, it is essential to sustain the temperature of the pins post-dip to encourage gelation until the films are adequately dried in the kilns.^11.12,13,14. Given that the structural integrity of HPMC shells is inferior to that of gelatin shells, extracting the capsule from the pins and subsequently handling and filling it poses challenges. To mitigate these difficulties, three strategies have been devised: employing a stripper jaw with inner surface depressions, enhancing the thickness of the formed HPMC film, and incorporating gelling agents.¹⁵ These HPMC vegetarian capsules provide the advantages associated with hard gel capsules, such as ease of ingestion, effective masking of taste and odor, and enhanced product visibility. Moreover, these HPMC capsules present a significant benefit over alternative solid dosage forms due to their unique advantages and prominent characteristics.¹⁶

Fig.2 Empty vegetable capsule shell

Fig.3 HPMC capsule, QUALI-V¹⁷

Advantages: Moisture level is 4-6% lower than gelatin capsules (13-16%), lowering the risk of microbial infection.

- Dissolves quickly and remains soluble in water at normal temperature, even under stress circumstances.

Disadvantages: - Manufacturing costs are high. As Vegetarian capsules are used more frequently now a days.

- It has lower tensile strength than gelatin capsule shells causes processing issues.

Table No. 1 Details on the empty HPMC capsule and their manufacturer:¹⁸

Capsule Shell BrandName	Manufacturer	Registered in year	Gelling Aid
Quali-V	Shionogi Qualicaps	July, 2002	Carrageenam
Vcaps Plus	Capsulgel (Adivision of Pfizer)	-	None
Vcaps	Capsulgel (Adivision of Pfizer)	April, 2003	Gellan gum
VegiCaps	G.S. Technologies Inc. (now R.P. Scherer Technologies ownership)	May, 1989	None
Natural Plant Capsule	Zhejiang LinFeng Capsules Co.Ltd.	-	Carrageenam
Capstech’s HPMC	Baotou Capstech Co.Ltd.	-	None
Embo Caps-Vg	Suheung Capsules Co.Ltd.	-	Pectin and Glycerin

Pullulan capsule shell:

Pullulan is a naturally occurring, water-soluble polysaccharide with a high molecular weight, derived from starch or saccharides through microbial fermentation. Pullulan capsules serve as an excellent alternative to materials prone to oxidation, as they are entirely biodegradable, odorless, and tasteless. With a lower moisture content (10–15%) compared to gelatin, they are also less toxic. These capsules are chemically inert, meaning they do not react or cross-link with their contents, thus maintaining high stability during storage, including mechanical and dissolution characteristics. Pullulan provides the most effective oxygen barrier among all plant-based products, making these capsules beneficial for masking strong odors from ingredients and enhancing the protection of sensitive components.

Fig.4 Chemical Structure of Pullulan.²⁷

Advantages: - They are chemically inert and do not react with capsule contents, resulting in good stability throughout storage, including mechanical and dissolving qualities.

They have low water content and show low toxicity as compared to gelatin.

Disadvantage: - Greater sensitivity to low moisture conditions compared to gelatin and HPMC, this sensitivity leads to increased shell brittleness at low water content.¹⁸

Starch capsule shell:

The plant kingdom's polysaccharide strength store resource is starch. Which consist of amylopectin, a highly branched, high molecular weight glucan, and amylose, a linear α- (1→4) glucan. Amylopectin contains α– (1→4) glycosidic bonds with α– (1→6) branch points.^19,20 One of the most widely accessible biopolymers is starch, which can be derived from a variety of plant sources, including corn, rice, cassava, potatoes, and others. It is also biodegradable and reasonably priced. It is composed of two polysaccharides made from glucose monomers, amylose and amylopectin. When plasticizing chemicals are introduced, starch exhibits thermoplastic behavior, increasing film flexibility, but it is not an effective barrier against oxygen or humidity.²¹ Starch-based capsules work well with alkaline formulations and those that contain strong acids, alkalis, or salts, unlike soft gelatin capsules that need formulations within a particular pH range.^22,30 Starch can be made using water and standard plasticizers like sorbitol, glycerol, etc. (10–60% w/w of dry shell) to create a molten mass that can be extruded to set in less than 20 seconds, creating elastic, mechanically strong films on temperature-controlled casting drums. As with soft gelatin capsules, sealing may be performed using a fusion method that works at temperatures ranging from 25 to 80°C. Products that are very elastic and mechanically robust can be produced once they have dried. Lipophilic fill compositions used in prototype capsules give them a glossy appearance that holds up well over time. When subjected to high humidity and temperature, the capsule shells do not crosslink and show more mechanical resilience than soft gelatin shells; that is, they may not become sticky even in hot and humid storage conditions. The mechanism of dissolution is entirely different from that of a soft gelatin capsule. Amylases are necessary for the enzymatic breakdown of shells; when the capsules come into contact with amylase-free aqueous media at 37°C, their contents can only be released through swelling-induced disintegration.²³

Fig. 5 Chemical Structure of Starch with Amylose and Amylopectin.²⁷

Advantages: Dissolution is independent of pH.

- Provide superior resistance to heat and humidity compared to gelatin while enabling easy filling due to their non-static nature.

Disadvantage: The utilization of plain starch capsules is restricted in effectively delivering substances to the lower sections of the digestive tract. Therefore, an enteric coated starch capsule shell can offer targeted delivery, but it may significantly raise expenses.²⁴

Polyvinyl Alcohol Capsule Shell:

The International Patent Application WO 9 755 3723 describes the optimal use of polyvinyl alcohol (PVA) along with the optional addition of various other substances, all of which are film-forming polymers lacking the gelling properties necessary for the conventional rotary die method of soft capsule production. Consequently, the invention provides for the use of preformed rolls of nearly water-free plasticized films that can be delivered to a rotary die encapsulation unit for the manufacture of soft capsules. To enhance the flexibility of the film material and facilitate seam formation at temperatures determined by the film's composition, the films undergo partial spray solvation prior to encapsulation.²² The films produced from polyvinyl alcohol (PVA) as outlined in this invention may comprise 70–75% w/w PVA, 10–15% w/w glycerol, and 5–10% w/w starch, with a sealing temperature ranging from 140–180°C, which is contingent upon the degree of solvation. When utilized as a substitute for gelatin, PVA presents the benefit of reduced hygroscopicity, resulting in soft capsule shells that are less susceptible to moisture-related issues compared to soft gelatin capsule shells. Furthermore, these capsules dissolve readily in water and exhibit no propensity for cross-linking. Polyvinyl alcohol (PVA) copolymer capsules are a form of non-gelatin capsule currently under development. The foundational materials include PVA, acrylic acid (AA), and methyl methacrylate (MMA). As previously noted, these capsules provide advantages such as low gas permeability and are particularly suitable for encapsulating hydrophilic solvents like polyethylene glycol (PEG) 400 and surfactants. The use of these capsules facilitates the formulation of insoluble medications and is expected to enhance bioavailability. PVA copolymer capsules were fabricated using the dipping and forming method, with carrageenan (0.05-0.5%) added as a gelling agent and potassium chloride (0.05-0.5%) included as a gelling enhancer. This approach necessitates no extra investment for capsule manufacturers since standard gelatin capsule production machines can be utilized. Prototype PVA copolymer capsules were tinted, exhibited a nice shine, and were similar to traditional capsules.²⁵

Fig.6 Chemical Structure of Poly Vinyl Alcohol.²⁷

Advantages: They are water soluble and less hygroscopic than gelatin.

The oxygen permeability of the PVA copolymer is notably lower as compared to gelatin and HPMC capsules.

Disadvantages: Moisture from the surroundings softens the material.

Lowering the hardness and trying to enhance it with another co-polymer can reduce polymer solubility.²⁴

Alginate Capsule Shell:

Alginate is a naturally occurring polysaccharide sourced from brown sea algae and certain microorganisms. It is characterized by its non-toxic and biodegradable properties. Sodium alginate, the sodium salt of alginic acid, is a natural polysaccharide composed of a linear arrangement of β-D Mannuronic acid (M) and α-D-glucuronic acid (G) residues in varying proportions and configurations. Sodium alginate is water-soluble and exhibits a reticulated structure. It can undergo cross-linking with divalent or polyvalent cations, resulting in an insoluble meshwork. Calcium and zinc cations have been identified as effective cross-linkers for the acid groups of alginate. In contrast, alginic acid is insoluble in water, which is why sodium alginate is utilized. Alginate capsule shells provide a vegetarian, enteric, and seamless alternative to gelatin soft capsules, making them suitable for pharmaceutical and nutraceutical applications.²³

Fig.7 Chemical Structure of Alginate.²⁷

Advantage: Capsule manufacturing is easier and more cost-effective per unit.

Smaller capsules with a seamless, thinner shell can boost patient compliance by 30% compared to regular gelatin capsules.

Disadvantages: Alginate capsule shells have a limited shelf life, when they are exposed to moisture and heat.

Alginate capsule shell are not widely available as compared to other types of shells.

Table No.2 Comparison of gelatin capsule and vegetable Capsule:¹

Gelatin Capsule	Vegetable Capsule
Animal derived (cow skin, bovine, pig fat) products are used.	These are 100% Vegetarian derived from plants and vegetables.
Gelatin is mainly used.	HPMC, Starch, PVA are mainly used.
GRAS listed in FDA	GRAS listed in FDA
These are certified by Kosher.	These are certified by Kosher.
Microbial growth can be seen.	No microbial growth is seen.
These are not suitable for vegetarian requirements.	Suitable for cultural, religious and dietary requirements.
They are less stable.	They are highly stable.

Table No.3 Comparison of Capsule Characteristic:¹⁸

Property	PVA Copolymer	HPMC	Gelatin
Water Content	2-5%	13-15%	4-6%
Goss	Low	High	High
Water Vapour Permeability	Low	Low	Low
Oxygen Permeability	High	Low	Very Low
Light Degradation	No	Yes	No
Static Electricity	Weak	Strong	Weak
Protease Degradation	No	Yes	No
Maillard reaction with filled substance	No	Yes	No
Solubility in water at room temperature	Soluble	Insoluble	Soluble
Filling of Macrogol 400	Impossible	Impossible	Possible
Filling of Tween 80	Impossible	Impossible	Possible

Challenges Faced When Implementing Vegetable Capsules:

Vegetable capsule implementation comes with a number of barriers, such as increased manufacturing costs, locating raw ingredients, formulation difficulty, encapsulation issues, regulatory obstacles, and quality control procedures.

Vegetable capsules can be more expensive for production than standard gelatin capsules. Limited availability of raw ingredients, such as cellulose or pullulan, can cause supply chain interruptions. The quality of vegetable capsules varies according on the supplier and manufacturing procedure. Vegetable capsules may have inconsistent disintegration times, affecting the release of active components. Vegetable capsules may be incompatible with certain fill materials, such as oils and fats. Some vegetable capsules, such as those composed of cellulose, are sensitive to moisture, which might compromise their integrity. Ensuring regulatory compliance for vegetable capsules can be difficult, particularly in nations with strict rules. Scaling up production of vegetable capsules can be difficult, particularly if the manufacturing process is complicated. Vegetable capsules have a short shelf life, particularly when exposed to moisture or heat. Some consumers may be cautious to move to veggie capsules, particularly if they are used to traditional gelatin capsules. Formulating vegetable capsules can be difficult, especially if the active components are sensitive to moisture or temperature. Stability testing for vegetable capsules can be difficult, especially if they are susceptible to moisture or heat.²⁸

The Cost of Vegetarian Capsule:

Vegetable capsules often cost more than gelatin capsules. The cost variation is primarily attributable to the raw materials utilized and the manufacturing process. Gelatin is derived from animal resources like bones and connective tissue, which are both affordable and abundantly available. Vegetable capsules, on the other hand, are manufactured from plant-based materials like cellulose or pullulan, which are more expensive to manufacture. In terms of specific expenses, gelatin capsules are frequently less expensive than veggie capsules due to cheaper raw material costs and a longer production history. However, the cost difference can vary depending on the individual application, capsule size and quantity, and the manufacturer, However, it remains within the budget. Many companies, both kosher and non-kosher, offer vegetarian capsules to their customers. People would use more vegetable capsules in future which will help in lowering the cost.²⁴

Evaluation Test for Vegetable Capsule:

Establishing quality guidelines for capsule shell evaluation is crucial for ensuring optimal dosage form performance. The following characteristics describe the test performed to evaluate the vegetable capsule shell.

Weight Variation Test: This test measures the homogeneity of capsule weight. Twenty capsules are separately weighed, and the average mass is estimated. The capsule mass should be ±10% of the average mass.

Content Uniformity Test: This test determines the homogeneity of the active component in the capsules. Thirty capsules are chosen and ten are tested separately. The requirements are met if 9 of the 10 are within the stated potency range of 85 to 115%, and the tenth is not outside of 75 to 125%.

Disintegration Test: This test examines how long it takes for the capsule to disintegrate. The capsule is placed in a glass tube, which is then introduced into the disintegration apparatus. The equipment moves the tube up and down, and the disintegration time is measured.

Leak Test: This test determines the strength of the capsule seal. The capsule is placed in a desiccator and a vaccume is applied. The capsule must maintain its shape, which indicates a good seal.

Friability Test: This test determines the capsule's tendency to shatter or crumble. A friability tester rotates a drum containing the capsules, and the weight loss is determined.

Dye Migration Test: This test determines the movement of dyes from the capsule shell to the filler material. A dye migration test is conducted with a spectrophotometer.

Accelerated Stability Test: This test determines the stability of the capsule under accelerated situations. An accelerated stability test is carried out in a stability chamber.

Heavy Metals Test: This examination identifies the existence of heavy metals in capsules. The concentration of heavy metals is assessed through either atomic absorption spectrophotometry (AAS) or inductively coupled plasma mass spectrometry (ICP-MS).²⁹

CONCLUSION:

Religious, cultural, and personal beliefs can significantly influence patients' preferences for medications in capsule form. Individuals who identify as vegetarians or vegans, as well as certain religious or ethnic groups such as Hindus, Jews, and Muslims, often adhere to dietary restrictions that exclude specific animal-derived products, leading to concerns regarding gelatin capsules made from animal sources. Additionally, there is an elevated risk of transmissible spongiform encephalopathies (TSE), including Creutzfeldt-Jakob disease (CJD), associated with the use of gelatin capsules. In such cases, vegetarian capsules present a more suitable alternative. Starch and hydroxypropyl methylcellulose (HPMC) are promising materials for producing both hard and soft capsules. However, one challenge in utilizing these alternatives is the substantial initial capital investment required. ³⁰

This review article emphasizes different polymers obtained from plant-based sources that can act as alternatives to gelatin capsules in the pharmaceutical and food sectors, tackling the limitations associated with conventional gelatin. In summary, gelatin-free capsule innovations have yet to be fully applied in the industry. Plant-based or synthetic polymer capsules are a promising alternative to gelatin capsules, potentially gaining market share for niche products due to their plant-derived materials and regulatory benefits.

ACKNOWLEDGEMENT:

In this transformative journey, my heartfelt gratitude extends to my family, friends, and cherished loved ones. I would especially like to thank our Director, Dr. Akhlesh Kumar Singhai and Dr. Ashish Jain for their wonderful support and time for successful completion of this paper. Their unwavering support, belief, and encouragement have been my guiding light. I reserve a special place of thanks for my dear friends, whose inspiration has been my constant companion.

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31. Monograph for Hard Cellulose Capsule Shells, Amendment list -004 to the 7th edition of Indian Pharmacopoeia 2014.

32. Hard Hypromellose Capsule shells monograph, USP, Pharmacopeial Forum (PF) 42(4) and PF 44(5), The United States Pharmacopeial Convention 2021.

Received on 30.06.2025 Revised on 18.08.2025

Accepted on 27.09.2025 Published on 08.10.2025

Available online from October 17, 2025

Asian J. Pharm. Tech. 2025; 15(4):377-384.

DOI: 10.52711/2231-5713.2025.00055

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.

Sr. No.	Name of Pharmacopeia	Status of monograph	Remarks
1.	Indian Pharmacopoeia (IP)	Monograph published	Documented in AMENDMENT LIST -004 to the 7th edition of the Indian Pharmacopoeia 2014, published on November 28, 2016.³¹
2.	United State Pharmacopoeia (USP)	Draft monograph published	A new draft monograph for Hard Hypromellose Capsule shells (HPMC or plant-based capsules) has been introduced in Pharmacopeial Forum (PF) 42(4) and again in PF 44(5) dated March 2, 2020, and it has yet to be made official in the USP.³²
3.	European Pharmacopoeia (Ph.Eur.)	No monograph published	Not yet published
4.	British Pharmacopoeia (BP)	No monograph published	Not yet published
5.	Japanes Pharmacopoeia (JP)	No monograph published	Not yet published