CHEMICAL PRODUCT DESIGN Obat Anti Kolesterol Berbahan Dasar Herbal

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Dipresentasikan Oleh : Annisa Yulian 1006706132 Johannes L Sasiang 1006706252 Karina Octavia Viriyo 1006706284 Yusra Yuliana 1106139935

Generating Concept
Sources of Ideas Collecting The Ideas New Ideas Concept Combining Existing Ideas and New Ideas

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Sources of Ideas
Consumers These ideas come from the answer or our questioners that we got before to gain the consumers need for our Anti-Cholesterol Drug Made from Herbs. Literatures Literatures such as patents, books, and journals are used to give us some information about current product and how do we need to do to make our product have the best performance. Product experts Product experts are the lecturer and their assistant who have some experience in chemical product design. They give us some advices to generate the best performance product design.

Collecting The Ideas

After knowing the specifications of the product and doing benchmarking with some competitor products, now we can generate some ideas underlying concept design of our product. Collecting ideas to make the best performance of Anti-Cholesterol Drugs Made from Herbs is done through some steps. These steps help us to have an systematic way of thinking to get the best product.

Collecting The Ideas

Figure 5.1. Scheme of Creating Concept

Step 1: Problem Decomposition

To generate the ideas we need to clarify the problem of out chemical product design. First, break the problem into some sub-problems.

Step 1: Problem Decomposition

1. Anti-Cholesterol Drug Some problems that would come up from this sub-problem are:
What is the meaning of anti-cholesterol drug? What is the function of anti-cholesterol drug? How the mechanism of drug to lowing cholesterol level in blood? Mention the kind of drug dosage forms and how to use that kind of drug? What are the side effects of consuming anti-cholesterol drug? What are criteria or condition of dozing a anti-cholesterol drug?

2. Made from Herbs Some problems that would come up from this sub-problem are:
What is the meaning of herbs? Mention some herbs that can lower cholesterol level! What substance that is contained in herbs which can lower cholesterol level? What are additional functions of herbs in anti-cholesterol drug?

Step 1: Problem Decomposition

In addition of sub-problems above, we need to consider about other problem that relate to our product. Those are: What would happen if people with high level of cholesterol who do not consume any drug to lowing the cholesterol level?
They need to maintaining diet Easy to have dizzy Frequent feel achy body Need to maintain the emotional stability

What are the side effects by consuming anti-cholesterol drug which is not made from herbs?
Sleepy Palpitation Kidney damage Nausea Low bioavailability Liver damage

Step 2: Existing Ideas Concept

Simvastatin Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product ofAspergillus terreus. It contains 3-hydroxy-3methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and ratelimiting step in the biosynthesis of cholesterol.
US Patent Application Publication No: US 2008/0300233 A1 This is a patent which contain Pharmaceutical Composition Comprising Simvastatin and Ezetimibe. This patent also used to make benchmarking between existing product simvastatin and own product. Composition of simvastatin is shown in Table IV.4.

Figure 5.2. Structural Formula of Simvastatin

Step 2: Existing Ideas Concept

Atorvastatin or Lipitor Lipitor is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.
European Patent Specification No: EP 2 117 534 B1 This is a patent which contain A Pharmaceutical Composition With A Atorvastatin In Active Ingredient. This patent also used to make benchmarking between existing product atorvastatin or lipitor and own product. Composition of atorvastatin or lipitor is shown in Table IV.5.

Figure 5.3. Structural Formula of Atorvastatin or Lipitor

Step 2: Existing Ideas Concept

Pro-Lestor
Pro-Lestor is the example of cholesterol-lowering drug that made from herbs. Observation of this existing product was mostly done by visualized analysis since there was still not much article or patent that discuss about this product. Pro-Lestor are available in form of tea wrapped in paper bags and packed in plastic transparent bottle. Pro-Lestor contain 100% percent of herbs, such as Guazuma Ulmifolia Folium, Syzygium Polyantum Folium, Andrographis Paniculata Folium, Persea Americana Folium, Camellia Sinesis Folium.

Step 2: Existing Ideas Concept

Figure 5.4. Concept Tree of Existing Ideas

Step 3: New Ideas Concept

Figure 5.5. Concept Tree of New Ideas

Step 4: Combining Existing Ideas and New Ideas

In this step, the existing ideas and new ideas are combined to make one or some new innovative idea which can be the same, less or better in performance. These combined ideas are arrange in a new concept tree which will be the beginning of concept selection process.

Figure 5.6. Concept Tree of Combined Existing and New Ideas

CONCEPT SELECTION
Concept Screening Concept Scoring

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Concept Selection
The purpose of this concept selection step is to find some feasible and best concept idea to proceed in chemical product design will be made. Concept selection is a step to evaluate all of the concept ideas that have been collected in previews chapter. There are two steps to selecting one concept idea, including concept screening and concept scoring.

Concept Selection

Figure 6.1. Concept Development Funnel

Concept Screening
1. Bioavailability
Bioavailability is a pharmacokinetic term that describes the rate and extent to which the active drug ingredient is absorbed from a drug product and becomes available at the site of drug action. Thus, bioavailability is concerned with how quickly and how much of a drug appears in the blood after a specific dose is administered. The bioavailability of a drug product often determines the therapeutic efficacy of that product since it affects the onset, intensity and duration of therapeutic response of the drug.

2. Pharmacodynamic
Pharmacodynamics refers to the relationship between drug concentration at the site of action and the resulting effect, including the time course and intensity of therapeutic and adverse effects. The effect of a drug present at the site of action is determined by that drugs binding with a receptor. For most drugs, the concentration at the site of the receptor determines the intensity of a drugs effect. However, other factors affect drug response as well.

Concept Screening
3. Pharmacokinetic
Pharmacokinetics is currently dened as the study of the time course of drug absorption, distribution, metabolism, and excretion. A drugs effect is often related to its concentration at the site of action, so it would be useful to monitor this concentration. Obviously we cannot directly sample drug concentration in this tissue. However, we can measure drug concentration in the blood or plasma, urine, saliva, and other easily sampled fluids.

Concept Screening
In addition of drug performance in human body, some criteria to screen the concept ideas are based on ingredients that are already chosen. Olive Oil Olive oil contains antioxidants that can lower LDL cholesterol without affecting HDL cholesterol is good for health. Olive oil can be used instead of vegetable or cooking oil instead of butter for meat splatter. Some studies have suggested using extra-virgin olive oil, which means that the oil does not go through a lot of the production process and contains more healthy antioxidants.

Red Yeast Rice Red yeast rice or usually called as angkak contain monakolin K which is identical to lovastatin (chemical substance that can lowering cholesterol level in blood by inhibit HMG Ko A). This mechanism of lowering cholesterol level has been described previously. Red yeast rice also contains water soluble fiber and unsaturated fatty acid that can absorb fats.

Concept Screening
Coconut Oil Coconut oil consists of medium-chain fatty acids (MCFAs) or medium-chain triglycerides (MCT). MCT quickly burned and can even convert stored fat into energy in the body, leading to weight loss or reduction of cholesterol levels. Avocado Fats from avocado are not dangerous because it is in monounsaturated fat. This type of fat can increase good cholesterol (HDL = High Density Lipoprotein) and lower levels of triglycerides in the blood, in addition to fat avocado can also keep the body from the damaging effects of bad cholesterol (LDL = Low Density Lipoprotein). Avocado also contains vitamin A, B complex, C and E. Peanut Skins Peanut skin contains a phytosterol that it can lower cholesterol and triglyceride levels, by restraining the absorption of cholesterol from food is circulated in the blood and reduce the re-absorption of cholesterol from the liver, and maintains HDL cholesterol.

Concept Screening
Table VI.1. Concept Screening Matrix
No Criteria Referene Concept (11) 1 2 3 4 Easy to make Easy to packaging Easy to use 0 0 0 0 0 0 0 0 0 + + 0 + + + 0 + 0 + + 0 0 0 0 + 0 0 + + 0 + 0 0 + 0 + 0 0 1 2 3 4 5 6 7 8 9 10

Pharmacodynamic 5 Pharmacokinetic 6 Bioavailability 7 Cost Total + Total Total 0 Total Rank Yes/No

0 0 0 0 0 7 0 -

0 0 0 0 0 7 0 7 No

0 0 0 2 0 5 +2 3 Yes

+ 4 3 0 +1 5 No

+ + 4 1 2 +3 1 Yes

+ + 3 1 3 +2 3 Yes

0 + 0 2 1 4 +1 5 No

0 + 3 1 3 +2 3 Yes

+ 0 2 2 3 0 7 No

+ 0 3 2 2 +1 5 No

+ 1 4 2 -2 10 No

Concept Screening
Table VI.2. List of Concepts
Concept Form How to Use Packaging

Reference 1 2 3 4 5 6 7 8 9 10

Tablet Tablet Coating tablet Solid gazette Guttea Pasta Kapsul Softgel Granule Granule Tea

Drink with water Drink with water Drink with water Sucked like candy Dripped into the mouth Sucked like candy Drink with water Drink with water Dissolved in water Sprinkled over food Boiled in water

Wrapped in aluminum Wrapped in aluminum In the bottle In the small box In the bottle In the bottle Wrapped in aluminum In the bottle Wrapped in aluminum Wrapped in aluminum In the filter paper

Concept Screening
Sign + : indicates that the concept of the idea of "better" than the reference concept. Sign : indicates that the concept of the idea of "worse" than referenca concept. Signs 0 : indicates that the concept of the idea of "as good as" referenca concept.

Concept Scoring
Easy to make, percentage = 10%
Easy to make is one of industrial needed which will always exist in every criteria of concept selection. This criteria selection is considering the relation of drug dosage form and ingredients of drugs, and also contains benchmarking with the reference concept.

Easy to package, percentage = 10%

Easy to package is also one of industrial needed that relating drug dosage form and packaging. Every different form of drug needs a different packaging material and packaging process. For example, granule drug is not packaged with bottle or wrapped in aluminium but it needs a piece of paper or a sachet. It happens because every single drug form needs a different package to seal and to measure the dosage.

Easy to use, percentage = 15%

Easy to use is one of consumer needs and also one of the major considerations in concept generating. This criteria gives a lot idea how the drugs should be packed, or what

Concept Scoring
Pharmacodynamic, percentage = 10% Pharmacokinetic, percentage = 5% Bioavailability, percentage = 15% Packaging cost, percentage = 5% Manufacture cost, percentage = 10% Resistance to contaminant, percentage = 7.5% Resistance to temperature, percentage = 7.5% Resistance to humidity, percentage = 5%

After mention the criteria with their scoring percentage that will be used to evaluate som qualify concept, now arrange the concept scoring matrix with value of scoring: 1 : very bad 2 : bad 3 : equal 4 : good 5 : very good Below will be a concept scoring matrix for some qualify concept from concept screening before:

Concept Scoring
Table VI.3. Concept Scoring Matrix
No Criteria Percentage Rating 2 Score Rating 4 Score Rating 5 Score Rating 7 Score

1
2 3 4 5 6 7 8 9 10 11

Easy to make
Easy to packaging Easy to use Pharmacodynamic Pharmacokinetic Bioavailability Packaging cost Manufacture cost Resistance to contaminant Resistance to temperature Resistance to humidity Total Rank

10%
10% 15% 10% 5% 15% 5% 10% 7.50% 7.50% 5% 1

4
3 3 5 5 4 3 2 4 3 3

0.4
0.3 0.45 0.5 0.25 0.6 0.15 0.2 0.3 0.225 0.15 3.525 3

4
4 5 4 5 5 4 2 4 3 3

0.4
0.4 0.75 0.4 0.25 0.75 0.2 0.2 0.3 0.225 0.15 4.025 1

2
3 4 3 3 3 3 3 3 3 3

0.2
0.3 0.6 0.3 0.15 0.45 0.15 0.3 0.225 0.225 0.15 3.05 4

3
5 3 5 5 5 2 2 5 4 4

0.3
0.5 0.45 0.5 0.25 0.75 0.1 0.2 0.375 0.3 0.2 3.925 2

Concept Scoring
Table VI.4. List of Qualified Concept
Concept Reference 2 4 5 7 Tablet Coating tablet Guttea Pasta Softgel Form How to Use Drink with water Drink with water Dripped into the mouth Sucked like candy Drink with water Packaging Wrapped in aluminum In the bottle In the bottle In the bottle In the bottle

Concept Testing
This concept testing proving that selected concept product can be accepted by people and give some critics or advice to improve our product according to people needs.

Concept Testing
Seven steps in concept testing 1. Decide the purpose of concept testing
The purpose of this concept testing is to know consumers respond for selected concept product whether in accordance with consumers needs. And also to analyze and estimate the product capacity need to be produced.

2. Decide observation populations

This observation is done to 25 people in age about 19 50 years that also considering about drug problem.

3. Decide observation format

There are some ways to get consumers respond that can used in this observation, such as interview and questioner. But, we need to publish our product to the people. We can publish our product in many ways, such as: Verbal Description, Sketch, 2D or 3D Photograph, Storyboard, Video, Simulation, Interactive Multimedia, Physical Model, Prototype

Concept Testing
4. Communicating concept product
Our concept product is communicated by in a form of verbal description. Our product description, information and some questions are including in this verbal description. This verbal description is made into a brochure that can be spread to many people. Communicating our concept product is have to be done in good, clear and easy to understand language to attract the consumers to read and give some responds.

5. Determining consumers respond

This is the result of observation that have done to 25 people. I will definitely buy : 4 people I may buy : 12 people I hesitant to but : 7 people I will not buy : 2 people No answer : 0 people

Concept Testing
6. Result interpretation
The result of observation above is interpreted to a pie chart form to facilitate understanding. The pie chart of observation result is shown below.

Concept Testing Result

8% 28% I may buy I hesitant to but I will not buy 16% I will definitely buy

48%

Figure 6.3. Concept Development Result

Concept Testing
7. Data analysis
From the result of concept testing, 16% from respondent say that they will definitely buy our product, 48% may buy, 28% hesitant to buy but there are 8% of respondent who will not buy our product. Several reasons why the respondent dont want to buy our product is because they feel that they dont need this product due to their paradigm that they dont want to consume any drug.

Conclusion
There are 5 steps to generate some concept ideas of our product, they are:
Step 1: Problem Decomposition Step 2: Existing Ideas Concept Step 3: New Ideas Concept Step 4: Combining Existing Ideas and New Ideas Step 5: Look Back The Ideas To Problem Decomposition

There are 3 steps to select the best concept product, they are:
Step 1: Concept Screening Step 2: Concept Scoring Step 3: Concept Testing

Our selected concept product for Anti-Cholesterol Drug Made From Herbs is oral guttae (drop) drug.

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