Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered a pre-requisite for the acceptance and approval of any pharmaceutical product. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to the stability of pharmaceutical products have been presented in a concise manner in the present review.

Acid proteases represent an important group of enzymes, extensively used in food and beverage industries. There is an increased demand for acid proteases adapting to the industrial extreme environment, especially lower pH. Thus, this necessitates the search for a better acid protease from fungi that best performs in industrial conditions. The fungal isolates were isolated from grape and dairy farm soil using potato dextrose agar and further screened for protease production based on the hydrolysis of clear zone on skim milk agar. The potential fungi were then subjected to secondary screening under solid-state fermentation (SSF). After the secondary screening, the potential fungus was identified to the genus level by the macroscopic and microscopic methods. The growth conditions and media composition for the potential fungus were further optimized under SSF. The crude enzyme produced by the potential isolate was characterized after partial purification by acetone and ammonium sulfate precipitation. A total of 9 fungal isolates showed protease production in primary and secondary screening; however, one potential isolate (Z1BL1) was selected for further study based on its protease activity. The isolate was identified to the genus Aspergillus based on their morphological features. The maximum acid protease from the isolate Z1BL1 was obtained using fermentation media containing wheat bran as a solid substrate, 1 mL of 3.2 × 106 inoculum size, 50% moisture content, and pH 4.5 upon 120-h incubation at 30°C. The acetone-precipitated enzyme exhibited the maximum activity at 50°C and pH 5 with stability at pH 4–6 and temperature 40–60°C. Thus, the acid protease produced from Aspergillus showed suitable enzyme characteristics required in the industry and could be a candidate for application in the food industry after further purification.

Acid proteases represent an important group of enzymes, extensively used in food and beverage industries. There are a diversification of food industries and thus an increasing demand for biocatalysts capable of adapting the industrial extreme environments. These demands can be covered by a plant and animal proteases; however there is a shortage to meet the present industrial demands. This necessitates the search for an alternative acid protease sources from fungi. The fungal isolates were recovered from grape and dairy farm soil using potato-dextrose Agar. The fungi were further screened for protease production based on the hydrolysis of clear-zone on skim-milk agar media. The potential fungi were then subjected to secondary screening under solid-state fermentation. After primary and secondary screening, the potential fungus (isolate Z1BL1) was identified to the genus level by combination of macroscopic and microscopic morphological study. The growth condition and media composition for potential fungal isolate (Z1BL1) was further optimized under solid-state fermentation. The crude enzyme produced from isolate Z1BL1 was characterized after partial purification by acetone and ammonium sulphate precipitation. A total of 9 fungal isolates were showed protease production in primary and secondary screening, however 1 potential isolate (Z1BL1) was selected for further study based on its protease activity. The potential fungus, isolate Z1BL1 was identified to the genus Aspergillus based on their morphological features. The optimization of media composition and growth conditions for acid protease production from Z1BL1 were slightly increased the protease activity. The acetone precipitated enzyme exhibited the maximum activity at 50 0C and pH 5 with stability at pH 4-6 and temperature 40-60 0C. Thus based on the above findings, the acid protease produced from Aspergillus was shown suitable enzyme characteristics required in industry and could be a candidate to be applicable in food industry after further purification by high resolution techniques.

The research was conducted with the aim to formulate and evaluate whey-based ready-toserve (RTS) therapeutic beverage from Aloe debrana juice and determine the phytochemical composition and sensory acceptability of the formulated therapeutic beverage. The whey and Aloe debrana juice were prepared in three blending ratios including WA1 (70:30), WA2 (80:20), and WA3 (90:10) respectively; and control (100% whey) with the addition of ingredients such as: sugar 15 g/100 mL, vanilla 0.1 g/100 mL, starter culture of Streptococcus thermophiles and Lactobacillus bulgaricus (0.02 g/100 mL). The four formulations were generated by Central composite design (CCD). The formulated raw materials range 70% to 90% whey, 10% to 30% Aloe debrana juice, and control (100% whey). Design expert 7.0 software was used to formulate the two components. Therapeutic beverages were fermented for 9 hrs at 37°C and 120 rpm using shaker incubator. Mineral contents (ppm) of the formulated beverage ranged from 375 to 573.01, 1244.02 to 1491.03, 460.01 to 742, and 93.02 to 107.0 of sodium, potassium, calcium, and magnesium, respectively. Phytochemical composition (mg/100 g) of the formulated beverages and Aloe debrana juice ranged from 43.20 to 147.56, and 4.98 to 11.17 for phytic acid and tannin respectively. The phytic acid and tannin content of Aloe debrana juice was (467.6 mg/100 g) and (130.1 mg/100 g), respectively. The therapeutic beverages were stored at room temperature for nine days without any change in sensory attributes. Sensory quality evaluation results showed that sample containing 70% whey and 30% Aloe debrana juice (WA1) scored the highest in overall acceptability 4.15, 3.7, 3.2, and 3.03 for the first, third, sixth, and ninth days of room storage temperature, respectively. Based on sensory quality evaluation parameters, therapeutic beverage containing 70% Whey and 30% Aloe debrana juice blend ratio revealed sensory acceptable for therapeutic beverage production. Therefore, it can be concluded that Aloe debrana juice can be incorporated with whey up to 30% to produce organolepticaly acceptable therapeutic beverages.