Ankita Kapoor

The need of the day is to produce the product that meets customer requirements. As pharmaceuticals are related to health care this should be vital part of industry to produce a product such as tablets, capsules, ointments, creams, gels and emulsions etc. with minimum variation satisfying the needs of customer. Customer requirements are translated into ‘Critical to Quality’ (CTQ) characteristics of the products that they are about to produce by the formulation scientists.  As example, hardness, thickness, uniformity of weight, assay, dissolution etc are CTQ characteristics of tablets, Content uniformity, viscosity, density are CTQ characteristics of a gel etc.  There are various sources of variation which can be monitored by the Quality by Design i.e., QbD approach. Process should be monitored and controlled by using statistical process control which includes six sigma approach, process capability and control charts. Some of the more frequently used indices are Cp and Cpk. Cp represents process capability while Cpk is the process capability index which are determined between USL and LSL which signifies upper specification limit and lower specification limit. Cpk of at least 1.33 is desired, and 1.5 is excellent and if there are not more than 3.4 defects per million units, then six sigma is achieved.

Domperidone is a water insoluble drug exhibiting poor dissolution pattern. Domperidone is an antiemetic and shows gastroprokinetic properties. It is a weak base and shows poor solubility in alkaline pH. Several methods are being employed to enhance the solubility of domperidone irrespective of its pH dependent solubility. The present protocol aim to design Polyethylene glycol (PEG) based solid dispersions of Domperidone to enhance its solubility. PEG 8000 based solid dispersions containing the drug in different mass ratio i.e. 1:1, 1:3, 1:5 and 1:7 were prepared using fusion method. The prepared solid dispersions were characterized for their drug content, phase solubility studies, Fourier-transform infrared (FTIR) spectroscopy, differential scanning calorimetry (DSC), x-ray diffraction, and in-vitro dissolution studies. All the formulations showed marked improvement in the solubility and dissolution rate of drug which may be due to decrease in crystallinity of drug and additives. It was concluded that prepared solid dispersion of the Domperidone with PEG can improve the solubility and dissolution rate of the drug.