521
therefore that measures aimed at preventing the initiation of oxidation processes
should be instituted during the production of RUTF (Manary 2006). For example,
heating of oils during mixing processes should be done at temperatures below 45 °C
to prevent oxidation of lipids. The use of airtight containers is and overly filled containers is recommended so as to limit the quantity of oxygen within the container
thus preventing the initiation of oxidative processes.
The mineral ingredients used in RUTF formula are water soluble and do not form
insoluble complexes when mixed together. Caution is exercised during production
of the foods to ensure that the mineral composition of the food will not alter the acid
base balance of children when administered for treatment of severe acute malnutrition (WHO & UNICEF 2007). It is recommended that the products have a moderate
positive non-metabolizable base sufficient to safeguard against the risk of metabolic
acidosis.
23.7 Shelf-Life Determination of Medical Foods and Infant
Formulas
The shelf life of medical foods and baby formulas vary according to manufacturer’s,
market and regulators’ needs, demands and requirements. Most of these foods are
designed to have a shelf life of not less than 24 months. Shelf life is determined
through research and development programs. They consist the identification of key
stability and deterioration indicators. These include physical appearance of the
products, chemical as well as microbiological susceptibility. Organoleptic analyses
are one of the most important technical but basic activities that can be carried out to
determine the taste-response relationship of the product and consumer’s acceptability over time. Shelf life tests results are all compared against standards usually
developed and provided by regulators. They are always required to be kept at
all times.
23.8 Pre-Clinical, Clinical Trials and Regulations
23.8.1 Pre-Clinical, Clinical Trials and Regulations
Infants are vulnerable because of many organs are immature and undergoing rapid
development. It should be given emphasis than food for adult who have developed
homeostatic mechanisms to cope up with and developed protective mechanism.
Therefore, it is important to assess the safety of infant formula by conducting preclinical and clinical study (Lönnerdal 2012).
23 Medical Foods and Infant Formulas
therefore that measures aimed at preventing the initiation of oxidation processes
should be instituted during the production of RUTF (Manary 2006). For example,
heating of oils during mixing processes should be done at temperatures below 45 °C
to prevent oxidation of lipids. The use of airtight containers is and overly filled containers is recommended so as to limit the quantity of oxygen within the container
thus preventing the initiation of oxidative processes.
The mineral ingredients used in RUTF formula are water soluble and do not form
insoluble complexes when mixed together. Caution is exercised during production
of the foods to ensure that the mineral composition of the food will not alter the acid
base balance of children when administered for treatment of severe acute malnutrition (WHO & UNICEF 2007). It is recommended that the products have a moderate
positive non-metabolizable base sufficient to safeguard against the risk of metabolic
acidosis.
23.7 Shelf-Life Determination of Medical Foods and Infant
Formulas
The shelf life of medical foods and baby formulas vary according to manufacturer’s,
market and regulators’ needs, demands and requirements. Most of these foods are
designed to have a shelf life of not less than 24 months. Shelf life is determined
through research and development programs. They consist the identification of key
stability and deterioration indicators. These include physical appearance of the
products, chemical as well as microbiological susceptibility. Organoleptic analyses
are one of the most important technical but basic activities that can be carried out to
determine the taste-response relationship of the product and consumer’s acceptability over time. Shelf life tests results are all compared against standards usually
developed and provided by regulators. They are always required to be kept at
all times.
23.8 Pre-Clinical, Clinical Trials and Regulations
23.8.1 Pre-Clinical, Clinical Trials and Regulations
Infants are vulnerable because of many organs are immature and undergoing rapid
development. It should be given emphasis than food for adult who have developed
homeostatic mechanisms to cope up with and developed protective mechanism.
Therefore, it is important to assess the safety of infant formula by conducting preclinical and clinical study (Lönnerdal 2012).
23 Medical Foods and Infant Formulas