HPMC for pharma grade film coating
*It is semi-synthetic in nature, derived from plant cellulose,
*Cross-linking problem with the excipients is totally absent since, the polymer is free from amino acids,
*Can be used for a variety of fill materials containing aldehydic group,
*It readily dissolves in cold water giving a colloidal solution owing to the reversible thermal gelation property,
*Forms a flexible film of controlled dimensions,
*Water does not act as a plasticiser for HPMC.
HPMC (Hydroxypropyl methylcellulose) Capsules are two-piece capsules made from cellulosic raw materials that satisfy vegetarian, religion, cultural and policy needs. These vegetable capsules are an attractive, all-natural dosage form that retain all the advantages - easy to swallow, effectively mask taste and odor, and allow product visibility. HPMC capsules are also starch-free, gluten-free and preservative-free, and meet the strict dietary needs of customers that choose a vegetarian lifestyle. HPMC capsules have been developed for both Health Supplements products and Nutraceutical.
Formula HPMC Specification
(n-2)/2
OR=-OH、-OCH3、-[OCH2CH(CH3)]nOH or-[OCH2CH(CH3)]OCH3
Plant Capsule Specification
Item | Results | ||
Tightness | grain | ≤1 | |
Friability | grain | ≤2 | |
Disintegration time limit | min | ≤15 | |
Burning residue | Transparent | % | ≤2 |
Semitransparent | % | ≤4 | |
Opaque | % | ≤6 | |
Loss on drying | % | ≤8 | |
Heavy metal | ppm | ≤10 | |
Arsenic salt | ppm | ≤2 | |
Microbial Limit | Total number of aerobic bacteria | cfu/g | ≤1000 |
Total Mold and Yeast | cfu/g | ≤100 | |
Escherichia coli | cfu/g | Not checked out | |
Total Staphylococcus aureus | cfu/g | Not checked out | |
HPMC Specification
Item | Results | ||
| ML-E3 | cp | 2.4～3.5 |
ML-E4 | cp | 3.6～4.5 | |
ML-E5 | cp | 4.6～5.5 | |
pH | 5.5～7.5 | ||
Insoluble matter in water | % | ＜0.4 | |
Loss on drying | % | ≤4.5 | |
Burning residue | % | ＜1.2 | |
Heavy metal | ppm | ＜10 | |
Arsenic salt | ppm | ＜2 | |
Methoxy（2910） | % | 28.0～30.0 | |
Hydroxypropyl（2910） | % | 7.0～12.0 | |
Microbial Limit | Total number of aerobic bacteria | cfu/g | ≤600 |
Total Mold and Yeast | cfu/g | ≤60 | |
Escherichia coli | cfu/g | Not checked out | |
Characteristics of plant capsules
The capsule has high transparency and good color.
Good formability and solidity after dipping in glue, which is more conducive to demoulding.
The capsule shell has uniform thickness and good toughness.
It does not contain chloroethanol, and the heavy metal indicators meet the requirements of the United States and European Pharmacopoeia.
HPMC packaging and storage
Barrel or paper plastic bag lined with polyethylene film inner bag. Net weight of each bag: 25kg.
Protect from sun and rain during storage and transportation.
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