Evidence map›Paper›PMID 35931906›Full record

ArticlePharmaceutical research2022

Process Modelling, Scale-Up and Characterization of Acetaminophen Spray Dried Milk Powder as Novel Pediatric Dosage Form.

Harsh S Shah, Urmilasri Syamala, Khushbu Chaudhari, Jignasa Savjani, Shital Butani

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Article in Pharmaceutical research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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5 · Who and what money

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5 authors.

Harsh S Shah *J-Star Research Inc., 6 Cedarbrook Drive, Cranbury, NJ, 08512, USA. harsh.shah@jstar-research.com.ORCID http://orcid.org/0000-0002-0678-5617
Urmilasri SyamalaDivision of Pharmaceutical Sciences, Long Island University, 1 University Plaza, Brooklyn, NY, 11201, USA.
Khushbu ChaudhariDepartment of Pharmaceutics, Institute of Pharmacy, Nirma University, Sarkhej-Gandhinagar Highway, Ahmedabad, Gujarat, 382481, India.
Jignasa SavjaniDepartment of Pharmaceutics, Institute of Pharmacy, Nirma University, Sarkhej-Gandhinagar Highway, Ahmedabad, Gujarat, 382481, India.
Shital Butani *Department of Pharmaceutics, Institute of Pharmacy, Nirma University, Sarkhej-Gandhinagar Highway, Ahmedabad, Gujarat, 382481, India. shital.butani@nirmauni.ac.in.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSuccessful drug therapy in children is contingent upon hassle-free administration of pediatric dosage forms. Pediatric patients suffer from difficulty in swallowing due to weak esophagus muscles in their early age. Considering this challenge liquid formulations are preferred over solid dosage form among pediatric patients to avoid the possibility of choking which can be a serious life-threatening condition in children. The main aim of the present research work was to develop a reconstitutable amorphous acetaminophen spray-dried milk powder (ASDM) as novel pediatric formulation.

methodsASDM was prepared by spray drying process and the spray drying process was optimized using Box-Behnken design to study the effect of spray drying process parameters at X

resultsPredicted parameters from optimized spray drying process model were successfully employed to manufacture a scale up cum validation batch of ASDM, which showed notably improved yield and desirable flow properties. The scale-up validation batch was further characterized using thermal analysis, diffraction studies, spectroscopic analysis, dispersion studies, stability APAP in dispersion formulation and formulation stability studies to confirm the physico-chemical stability of ASDM.

conclusionsThus, ASDM for oral use can serve as a promising pediatric formulation and the developed prototype formulation can be further extended to future newly discovered drugs with similar characteristics.

Indexed as

AcetaminophenChemistry, PharmaceuticalAnimalsChildDrug CompoundingHumansMilkParticle SizePowdersAcetaminophenPowdersacetaminophennovel approachpediatric formulationsspray dried milk powder

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