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NM-Carbomers processing guide for oral solid dosage forms

2022-06-28 16:55:39

Anhui Newman Fine Chemicals Co., Ltd is the one of the world’s largest manufacturers of pharmaceutical grade carbomers, and has been manufacturing carbomer excipients for more than10 years.

Our carbomers are excipients of chemically crosslinked acrylic acid. These carbomers have been successfully formulated into a variety of different commercial oral formulations, including swallowable (peroral), chewable, buccal, and sublingual tablets.

NM-Carbomers can impart the following to an oral solid pharmaceutical product:

Extended release

•Mucoadhesion/bioadhesion

•Taste-masking

•Size reduction (of tablets)

•Efficient binding


NM-Carbomer such as Carbomer 71G,974P,971P offer formulation flexibility as they can be used with a variety of active pharmaceutical ingredients (APIs) and excipients, and can be processed by direct compression, dry granulation (roller compaction,

slugging), or wet granulation (high/low shear, extrusion spherization) methods. NM-Carbomer such as Carbomer71G, 974P,971P provide highly effective controlled-release properties at low concentrations.

Typical usage levels in extended-release tablets are 5–30%, depending on the drug properties-excipients, and processing parameters.

Recommended Polymers for Solid Dosage Forms

Table 1. NM-Carbomers for oral solid dosage forms.

Product Name

Polymerization
Solvent

China (Ch.P.)

United States (USP/NF)

Europe (Ph. Eur.)

Japan

(JPE)

NM-Carbomer 974P

Ethyl Acetate

Carbomer Homopolymer
Type B

Carbomer Homopolymer
Type B

CARBOMERS

Carboxyvinyl

Polymer

NM-Carbomer 971P

Ethyl Acetate

Carbomer Homopolymer
Type A

Carbomer Homopolymer
Type A

CARBOMERS

Carboxyvinyl

Polymer

NM-Carbomer 71 G

Ethyl Acetate

Carbomer Homopolymer
Type A

Carbomer Homopolymer
Type A

CARBOMERS

Carboxyvinyl

Polymer


Regulatory Status of Carbomer

Regarding compendial classification, the European Pharmacopeia has only one monograph, titled“Carbomers”. Similarly, the Japanese Pharmaceutical Excipients (JPE) also has a single monograph titled“Carboxyvinyl Polymer.”The Chinese Pharmacopoeia (ChP.) monograph and United States Pharmacopeia/National Formulary has several monographs for different carbomer grades. The monographs applicable for oral pharmaceutical grade products based on polymer structure, are“Carbomer Homopolymer”in the table above. The differentiation between Type A and B within“Carbomer Homopolymer”is based on viscosity characteristics.

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