About aloe vera
Aloe vera manufacturers supply two different products: dried aloe leaf juice (aloes), used as a stimulant laxative, and aloe vera gel, used in skin care. Aloe vera (Aloe barbadensis Miller) is a succulent plant. In the EU, aloes preparations have a herbal monograph for short-term use in occasional constipation. Pharmaceutical companies can source aloes extracts, laxative products and aloe gel through supply or out-licensing.
Aloe vera key facts
|
Property |
Aloe vera |
|---|---|
|
Botanical name |
Aloe barbadensis Miller (aloe vera); also Aloe ferox (Cape aloes) |
|
Medicinal preparation |
Aloes: dried juice of the leaves (Aloes folii succus siccatus) |
|
Active constituents |
Anthranoids (hydroxyanthracene derivatives such as aloin) in the leaf juice |
|
Drug class |
Stimulant laxative (aloes); emollient (aloe gel) |
|
EU herbal monograph |
HMPC monograph on aloes, well-established use for short-term occasional constipation |
|
Dosage forms |
Tablets, capsules and liquids (laxative); gels and creams (topical) |
|
Age limit (laxative) |
Adults and adolescents over 12 years; maximum 1 week |
|
US status |
FDA does not recognise aloe as safe and effective for OTC laxative use |
|
Topical gel |
Sold mainly as cosmetic or skin care, not covered by the HMPC monograph |
|
Legal status |
Usually non-prescription |
Aloe vera manufacturers and licensing history
Aloes, the dried leaf juice, has long been used as a laxative. The EMA's Committee on Herbal Medicinal Products (HMPC) concluded that aloes preparations can be used short-term for occasional constipation, based on well-established use. Its conclusions cover preparations made by cutting the leaf near the base so the juice flows out, then drying it.
Aloe vera gel, from the inner leaf, is a different product. It is widely used in cosmetics and skin care and is not covered by the laxative monograph.
Aloe is grown commercially in Mexico, the US, South Africa, China and the Caribbean. Buyers should confirm the plant part, aloin content, GMP status and pharmacopoeial compliance before choosing a supplier.
Aloe vera dosage forms and dossier types
Aloe products are supplied as oral laxatives made from dried leaf juice and as topical gels made from the inner leaf. Laxative products follow herbal medicine rules, while gels are usually cosmetics.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Aloes dried juice extract (oral laxative) |
Per HMPC monograph |
EU well-established use (Art. 10a) |
Short-term occasional constipation |
|
Aloe vera gel (topical) |
Per product |
Cosmetic |
Not covered by the HMPC monograph |
|
Aloes / aloe gel raw material |
Bulk |
Supplier documentation; Ph. Eur. |
Aloin content is the key specification |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
European Union |
Herbal dossier (WEU) |
Follow HMPC monograph; anthranoid warnings |
|
United States |
Not applicable as laxative |
Not recognised for OTC laxative use |
|
Cosmetic markets |
Cosmetic notification |
Aloin limits; product claims |
Aloe vera regulatory and patent status
In the EU, the HMPC monograph supports well-established use of aloes for short-term occasional constipation. Use is limited to adults and adolescents over 12, for no more than 1 week, and it must not be used in pregnancy, breastfeeding, bowel obstruction or inflammatory bowel disease. In the US, the FDA does not recognise aloe as safe and effective for OTC laxative use. Aloe products are off-patent.
Aloe vera mechanism of action and therapeutic use
The anthranoids in aloes stimulate the muscle of the large intestine and increase the water content of the stool, which helps it pass. Aloes is used short-term for occasional constipation. Long-term use can cause electrolyte imbalance and discoloration of the gut lining. Aloe vera gel is used on the skin as a soothing and moisturising agent.
Aloe vera licensing and sourcing
Aloe vera suppliers and licensing partners typically offer extract supply, finished-product supply or dossier out-licensing. Buyers usually compare GMP status, plant part and aloin content, dossier type and territory availability. Current offers and supplier contacts are listed among the aloe vera manufacturers on Pipelinepharma.
Frequently asked questions about aloe vera
Who are the main aloe vera manufacturers? Aloe is grown and processed in Mexico, the US, South Africa, China and the Caribbean. Suppliers offer either dried leaf juice for laxatives or inner-leaf gel for skin care.
What is the difference between aloes and aloe vera gel? Aloes is the dried juice from the leaf, which contains laxative anthranoids. Aloe vera gel comes from the inner leaf and is used on the skin.
Is aloe approved as a laxative? In the EU, aloes has an HMPC monograph for short-term occasional constipation. In the US, the FDA does not recognise aloe for OTC laxative use.
Is an aloe vera herbal dossier available for licensing? Yes. EU well-established-use dossiers for aloes laxatives can be licensed, following the HMPC monograph. Topical aloe gel products are usually cosmetics.
Who should not use aloe laxatives? Children under 12, pregnant or breastfeeding women, and people with bowel obstruction, inflammatory bowel disease or unexplained abdominal pain should not use aloe laxatives.
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