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BRACKETING AND MATRIXING DESIGNS (Q1D)

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·          To reduce the total number of samples to be tested, the ICH guidelines introduced the concept of bracketing and matrixing. ·          BRACKETING ·          Definition : Bracketing is the design of a stability schedule such that only samples on the extremes (high level) of certain design factors (e.g., strength, container size and/or fill) are tested at all time points as in a full design. ·          The use of a bracketing design would not be considered appropriate if it cannot be demonstrated that, o    the strengths or container sizes and/or fills selected for testing are actually the extremes o    Bracketing can be applied to studies with multiple strengths where the relative amounts of drug substance and excipients change in a formulation. ·          An example of a bracketing design is given in following Table.  o    This example is based on a product available in three strengths and three container sizes.  o    In this example, it should be demons
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PLANT LAYOUT FOR CAPSULE MANUFACTURING DEPARTMENT & MANUFACTURING PROCESS

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PLANT LAYOUT  FOR CAPSULE MANUFACTURING DEPARTMENT: ENVIRONMENT CONDITION FOR CAPSULE FILLING AREA Humidity:          Not more than 35% RH Temperature:    Not more than 25% Area of each room, position of equipments, washing, drying, and sanitary facilities must be in accordance with GMP. MANUFACTURING PROCESS: CHEMCAPS Limited is an India based young and dynamic organization engaged in the manufacture and export of 'empty hard gelatin capsules' under the brand name of 'Chemlock' for discerning customers around the globe. COMPOSITION                                     Gelatin                                     Water                                     Colorants                                     Opecifier (TiO2 Dyes and Other)                                     Preservative MANUFACTURING OF HGC SHELL: SFR-901 FULLY AUTOMATIC CAPSULE MACHINE: FEATURES OF SFR-901 Ø   The Safrroys SFR-901 mod
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ANTIOXIDANTS: In Pharmaceutical Formulation

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Introduction: Chemically they are reducing agents. They oxidize themselves and prevent oxidation of API. A substance that inhibits oxidation is called antioxidants. The effectiveness of antioxidant can depend on the concentration used and pH of solution. Examples:  Ascorbic acid,  butylated hydroxy anisole (BHA),  butylated hydroxyl toluene (BHT) Oxidation is a chemical reaction involving the loss of electrons or an increase in oxidation state. Oxidation reactions can produce free radicals. In turn, these radicals can start chain reactions. When the chain reaction occurs in a cell, it can cause damage or death to the cell. Antioxidants terminate these chain reactions by removing free radical intermediates, and inhibit other oxidation reactions. The following are some of the qualities of an ideal anti-oxidant: It should be readily soluble or dispersible in the medium. It should be effective in low concentration. It should be non-toxic. It should be non-irrita
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3. Development of working hypothesis:

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After extensive literature survey, researcher should state in clear terms the working hypothesis or hypotheses. Working hypothesis is tentative assumption made in order to draw out and test its logical or empirical consequences. As such the manner in which research hypotheses are developed is particularly important since they provide the focal point for research. They also affect the manner in which tests must be conducted in the analysis of data and indirectly the quality of data which is required for the analysis. In most types of research, the development of working hypothesis plays an important role. Hypothesis should be very specific and limited to the piece of research in hand because it has to be tested. The role of the hypothesis is to guide the researcher by delimiting the area of research and to keep him on the right track. It sharpens his thinking and focuses attention on the more important facets of the problem. It also indicates the type of data required
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