Capsule filling and testing -LAW JIA JUIN

Title of Experiment: Capsule filling and testing 

Content of this report

A.     Objective

B.     Introduction

C.     Materials and equipment used

D.     Formulation for drug preparation

E.      Results and calculation

F.      Discussions

G.     Conclusion

H.     references

A.Objectives

1.                   To prepare hard gelatin capsules, using the powder mix and semi-automatic filling machine.

2.                   To evaluate the prepared capsules; for its disintegration characteristics as well as weight variation.

Notes: Disintegration test of capsule implies the same as tablet disintegration of tablets. However, it is usually not required for the capsules unless they have been treated to resist solution in gastric fluid (enteric-coated).

B.INTRODUCTION:

There are many different dosage forms available in the market for the delivery of a single drug, for examples, solution, suspension, powder, tablet and capsule. Capsules are solid dosage form of pharmaceutics medication, it is used to deliver drugs in a predetermined dose of medications so that patient can get an accurate dose and better compliance compare to solutions and suspensions. Capsules are gelatin shells filled with the ingredients that make up an individual dose. Dry powders, semi-solids, and liquids that do not dissolve gelatin may be encapsulated in it. They are used because:

1.      they mask the unpleasant tastes of a drug,

2.      they increase patient compliance.

2.   they allow powders to be dispensed in an uncompressed form, thus allowing for quicker dissolution and absorption of the drug following oral dosing (as compared with tablets).

3.They may be easier than tablets for some people to swallow.

There are 2 different types of capsules ,which are the hard-shelled capsules (going to be discussed in this report) and also the soft-shelled capsules. The hard gelatin capsule consists of a base or body and a shorter cap. The cap will fits firmly over the base of the capsule. They are eight sizes of capsules available fro human use. The capacity of each size varies according to the combination of drugs and their apparent densities. Capsules can also be classified as clear gelatin capsules or colors capsules.

Hard-shelled capsules are normally used to hold dry powdered ingredients or miniature pellets or tablets. Soft-shelled capsules are normally used for oils and also for active ingredients which are insoluble in water and are suspended in oil and they are encapsulated into capsules.

Generally, capsules are used to allow a better delivering of solid or liquid active ingredients It allows the solid active ingredient to be dissolved and absorbed quicker following an oral administration. Gelatin shells of capsules are smooth and slippery when in contact with our saliva, this is why I said that capsule is easy to be swallow by patient as compare to other solid dosage form.

In this experiment, the capsules produced are assessed. The 2 important aspects of in process quality control were conducted. The first one is weight variation test, and the second one is the disintegration test. In the weight variation test, 10 capsules were selected randomly from the batch produced. Each capsule was weighed individually, and the mass of individual capsule was compared to the average weight of the 10capsules. The weight variation of each individual capsule was calculated. The batch will be accepted if not more than two of the tablets differ from the average weight by more than the percentage listed and no tablet differs by more than double that percentage. For the disintegration test, 6 capsules were selected randomly, and all of them should disintegrate within 15 minutes. If one or two tablets fail to disintegrate completely, repeat the test on 12 additional tablets, not less than 16 of the total of 18 tablets tested must disintegrate completely.

C.Materials & equipments required

Weighing balance, Capsule filling machine, disintegration and dissolution test apparatuses, glass wares and the materials mentioned below.

D.Formulation for drug peparation

Formula	For one capsule (mg)	Calculated for  100capsules (gm)
Amoxycillin	250	25.00
Starch	q.s	4.65
Lactose	q.s	4.65
Aerosil	2%	0.70

                                  

E.Results and calculations:

1.Weight variation test

Weight variation (% ) = average weight – weight of individual tablet  X 100%

                                                       Average weight

Tablet Number	Weight of individual Tablet (g)	Weight Variation (%)
1	0.49	**[(0.5-0.485)/0.5] x100=+3%
2	0.5	0
3	0.51	-2
4	0.52	-4
5	0.52	-4
6	0.48	+4
7	0.48	+4
8	0.48	+4
9	0.5	0%
10	0.51	-2%
Average weight	(0.49+0.5+…..0.51)/10=0.5
Number of tablet outside the limits		0
Batch passes of fails		Passed

Average weights for the 10 capsules chosen are 0.5gm, thus the acceptable % weight variation +/-5%

***The calculation for % weight variation was done based on the formula above and an example of calculation was also given above.

Since there is no more than two of the tablets differ from the average weight by more than +/-5.0%  and no tablet differs by more than double that percentage,

*we can conclude by saying this batch of capsules had passed weight variation test.*

2.Disintegration Test:

All 6 capsules disintegrated within 4min (below 15 minutes).  

*This batch of capsule passed this disintegration test.*

F.Discussion:

For the weight variation test, 10 capsules were selected randomly from the batch produced. Each capsule was weighed individually, and the mass of individual capsule was compared to the average weight of the 10capsules. The weight variation of each individual capsule was calculated. The batch will be accepted if not more than two of the tablets differ from the average weight by more than the percentage listed and no tablet differs by more than double that percentage. Since the average weight of the 10 capsules was found to be around 0.485gm (more than 324mg), then the acceptable percentage weight variation should be +/-5.0 % . Since there is no more than two of the tablets differ from the average weight by more than +/-5.0%  and no tablet differs by more than double that percentage, we can conclude by saying this batch of capsules had passed weight variation test.

All the 6 capsules managed to disintegrate within 4minutes(less than 15 minutes) and hence we can say that this batch of capsules had passed the disintegration test. The standard steps and guidelines for the conduction of disintegration test are recorded in the USP 24 standard. Disintegration time of capsules is important because it has a direct effect on the bioavailability of drugs delivered by capsules. In fact the disintegration time of capsule should be optimum, not too fast nor too slow, for example, if the disintegration time of capsule is too short, they will start to disintegrate before reaching the site of absorption, this is not good as it will directly affects on the drug doses. If the capsule starting to disintegrate right in the mouth ,then for sure ,some portion of this disintegrated capsule may remained in the mouth or tooth, not reaching the site of absorption, hence the bioavailability of the medication will be reduce .On the other hand, if the time taken for disintegration is too long, then the drugs may not be released effectively, and again affecting the bioavailabilty and doses of this drug.

            Since in our experiment, the capsule filling process was done by semi-automated machine, Hence there were some problems encountered by us during the filling process. Firstly, during the filling of the capsules bodies and caps onto the upper mould A and upper mould B, we found out that some of the bodies or caps were filled inverted and hence hands were used to revert them manually. Secondly we realized that the powder filling process (into the bodies) was ineffective, as there were some powders dropped outside the frame or sticked on the original container containing the powder ,these will definitely affect the dose of drug in our capsule. Thirdly, the press pressure applied by the lever was not evenly distributed. Some of the capsules were distorted by the pressure applied. Besides that, upon removing the capsules from the press machine, there were some capsules which were not interlocked properly. These were due to the weak pressing. These weak interlocked capsules may open up and the medication are wasted.  All these errors may contribute to weight variations and also affect the quality of capsules produced. These errors can be minimized or even be avoided by using fully automated machine .

G.Conclusion

This batch of capsules prepared had passed both the weight variation test and disintegration test.

H.REFERENCE:

1.       Aulton Me. Pharmaceutics: The Science of Dosage Form Design. 2nd edition. Chapter 29 Hard gelatin capsule. Britain: Churchill Livingstone. 2002. p449-460.