1. ICH Drug development guidelines are included in, explain why: a. Q7 b. Q8 e.
ID: 701958 • Letter: 1
Question
1. ICH Drug development guidelines are included in, explain why: a. Q7 b. Q8 e. Q7, Q8, and Q9 d. Q8 and Q10 2. CFR 210 and 211 do apply to the manufacture of, explain why a. Drugs and biotech finished products b. Drugs and biotech finished products as well as to APIs. c. APls and drug finished products d. Drugs and biotech finished products as well as to APls and intermediates 3. Describe briefly the following operations in the Pharmaceutical Manufacturing Process: a. Powder Blending b. Milling c. Granulation d. Hot melt extrusion e. Production of dosage formsExplanation / Answer
3.
a) Powder blending
Blending is al unit operation used in pharmaceutical manufacturing as it is a prerequisite for the homogenous distribution of a drug’s component. the content of the active pharmaceutical ingredients (API) in the final solid dosage form is particularly very much important. Tablets out of specifications leads to expensive rework or even recalls, and even more important, dosage forms not compliant with the therapeutic window can cause harm to patients.
there are two main mechanism for blending. The 1st mechanism is due to the convective transport, in which large volumes are imposed by the blender. It is mainly influenced by the geometry of the blender, and also generates homogeneity on a large scale. The direction of mixing is aligned with the direction of particle moving. shear mixing is an outcome of convective transport. The 2nd mechanism is the diffusive blending, which is a result of the movement of the individual particle w.r.t the convectively transported particle. Here, mixing occurs perpendicular to the direction of flow. It is slower and based on the particle mobility,
b) Milling
Size reduction mills are used in the pharmaceutical industry for the reduction of active pharmaceutical ingredients (API's), as well as bulk pharmaceuticals ingredients (BPI's) and excipients such as lactose, HPMC (hydroxypropylmethyl cellulose) and others.
Size reduction is mainly used to increase surface area and to improve formulation dissolution properties.
It is also used to maintain average particle size distribution (PSD) for the formulation, thus allowing for a better mixture when creating tablets and capsules.
Conventional dry size reduction in the pharmaceutical industry is done by impact. This impact size reduction falls into 2 categories:
1)mechanical impact and
2)impact via fluid energy.
Examples of mechanical impact mills are hammer mills and pin mills,loop jet mills, while spiral jet mills, and fluidized bed jet mills are examples of micronizers or fuid energy mills.
In size reduction mills, for determining particle size distribution,the feed rate is an important factor. Since the resultant distribution is largely dependent upon residence time in the milling device, the feeder is an important tool in controlling this residence time..
c) Granulation
In the pharmaceutical industry, granulation refers to the process in which primary powder particles are made to adhere to form larger entities called granules. It is the process of collecting particles together by creating bonds between them. compression or by using a binding agent are used for forming bonds. it is extensively used in the manufacturing of tablets and pellets.
This process combines one or more powder particles and forms a granule that will allow tableting process to be within required limits. This way predictable and repeatable process is possible and quality tablets or pellets can be produced using tabletting equipment.
d) Hot melt extrusion
HME has more recently been applied to the health care industry where it is used to manufacture medical devices and to mix active ingredients (APIs) with polymers to enhance the API’s bioavailability. This technical brief discusses the equipment and principles of HME with a particular emphasis on its use in the pharmaceutical industry.
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