Pre-formulation and Stability Study of 20-mcg Clonidine Hydrochloride Pediatric Capsules.

ABSTRACT:

Objective

Clonidine hydrochloride is an antihypertensive, centrally acting α2 adrenergic agonist with various pediatric indications. For pediatric patients, 20-mcg clonidine hydrochloride capsules can be compounded from commercial tablets or from a pre-compounded titrated powder. These methods should be compared to ensure the best quality for the high-risk patients, and a beyond-use date should be established.

Methods

Eight experimental batches were made from commercial tablets and 8 were made from microcrystalline cellulose (MCC)-based titrated powders. Quality controls were performed to determine the best compounding protocol. Stability study was conducted on capsules compounded with the best method.

Results

Of 8 batches manufactured from commercial tablets, 7 were

SUBMITTER: Wasilewski M 

PROVIDER: S-EPMC9514770 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature