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Drug Product Stability01:16

Drug Product Stability

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The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...
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Related Experiment Video

Updated: Mar 17, 2026

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality
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Bifidus milk powder: processing parameter standardization and shelf stability evaluation.

Meenakshisundaram Selvamuthukumaran1, Selva Muthukumaran1, Shiv Shankar Shukla1

  • 1Department of Food Science and Technology, Jawaharlal Nehru Krishi Vishwa Vidyalaya, Jabalpur, Madhya Pradesh 482004 India.

Journal of Food Science and Technology
|July 15, 2016
PubMed
Summary

Spray-dried bifidus milk powder, incorporating Bifidobacterium bifidum, maintained acceptable organoleptic qualities and a 120-day shelf life. However, probiotic viability decreased significantly during storage at ambient temperatures.

Keywords:
Bifidobacterium bifidumBifidus powderHydroxymethyl furfuralPhysico-chemical propertiesShelf lifeSpray drying

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Area of Science:

  • Food Science
  • Microbiology
  • Dairy Technology

Background:

  • Probiotics, such as Bifidobacterium bifidum, offer health benefits but require careful processing for stability.
  • Spray drying is a common method for preserving microbial cultures in food products.
  • Maintaining probiotic viability and product quality during storage is crucial for functional foods.

Purpose of the Study:

  • To develop and standardize spray-dried bifidus milk powder using Bifidobacterium bifidum.
  • To evaluate the impact of storage on the physicochemical properties and microbial stability of the bifidus milk powder.
  • To determine the shelf life and consumer acceptability of the reconstituted product.

Main Methods:

  • Cow milk was supplemented and processed into a slurry, pasteurized, inoculated with B. bifidum, and spray-dried.
  • Physicochemical analyses (moisture, bulk density, HMF, TBA, reflectance) and microbial counts were performed during storage.
  • Organoleptic evaluation and shelf stability testing at ambient temperature (27 ± 2°C) were conducted.

Main Results:

  • A specific total soluble solids concentration yielded optimal organoleptic characteristics.
  • During 120 days of storage, moisture, bulk density, insolubility index, HMF, and TBA values increased, while reflectance decreased.
  • B. bifidum counts significantly reduced, becoming undetectable by the end of the storage period.

Conclusions:

  • Spray-dried bifidus milk powder can be produced with good initial quality and consumer acceptability.
  • Storage leads to significant degradation of physicochemical properties and loss of probiotic viability.
  • The product demonstrated a shelf stability of 120 days, but probiotic functionality is limited over this period.