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Asiatic Laboratories Limited 42-43, Siddeshwari Circular Road Dhaka-1217, Bangladesh

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TECHNICAL DISCUSSION ON CLINDAMYCIN TABLET

Asiatic Laboratories Limited 42-43, Siddeshwari Circular Road Dhaka-1217, Bangladesh

PRESENTED BY ASIFUL ALAM ID NO:31 B.Pharm : Noakhali Science And Technology University M.Pharm: North South University

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CONTENT

CLINDAMYCIN

MECHANISOM OF ACTION OF CLINDAMYCIN

INDICATION OF CLINDAMYCIN

ADVERSE EFFECT OF CLINDAMYCIN

OBJECTIVE FOR CLINDAMYCIN TABLET

INTERNATIONAL AND NATIONAL MARKET ANALYSIS

SWOT ANALYSIS FOR CLINDAMYCIN TABLET

POSTER PRESENTATION FOR CLINDAMYCIN TABLET

CONCLUSION

REFERENCE3

What is clindamycin? Clindamycin is an antibiotic of the lincosamide class, which blocks the

ribosomes of microorganisms.

It is usually used to treat infections with anaerobic bacteria, used to treat protozoal diseases, such as malaria. can be useful against some methicillin-resistant Staphylococcus aureus (MRSA) infections

It has primary bacteriostatic action

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Clindamycin 3d Clindamycin structure

Aerobic gram-positive cocci: Staphylococcus aureus and S.epidermis both pencillin and nono-penicillinase producing strains,streptococci except E.feacalis

Anaerobic gram-negative: Bacteroides spacies Fusobacterium Anaerobic and microaerophillic gram-positive cocci.

Clindamycin inhibit protein synthesis by revesibly binding to 50s subunits of the ribosomal thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting to stunted cell growth.

Spectrum of activity

Mechanism of Action

Bacteremia Bacterial Endocarditis Prophylaxis Deep Neck Infection Intraabdominal Infection Malaria Pelvic Inflammatory Disease

Indication of Clindamycin Infection of lower respiratory

tract Bone and joint infections Bacterial vaginosis Severe Acne Bacterial Infection Sinusitis, pneumonia Skin or Soft Tissue Infection

adverse of Clindamycin

• systemic clindamycin therapy — found in over 1% of people — include: diarrhea, pseudomembranous colitis ,nausea , vomiting, abdominal pain or cramps and/or rash, metallic taste.

• topical formulations - found in over 10% of people - include: dryness, burning, itching of skin.

• Gastrointestinal: Abdominal pain, nausea, vomiting and diarrhea and esophagitis with oral preparations.

• Hypersensitivity Reactions: Maculopapural rash and urticaria have been observed during drug therapy.

• Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.

Objectives of Clindamycin Tablet

To make Clindamycin tablet To make Clindamycin as a reknown brand

of Company as well as in IM. To make Clindamycin tablet as a highest

selling products of Company. To make Clindamycin tablet as a highest

prescribed product of company. To make Clindamycin a loyal brand.

Business Unit Strategic Planning For Clindamycin tablet

Figure : outlines strategic planning at the SBU level.

• Strategic• Analysis of

marketing opportunities

• Target marketing decisions

• Value proposition

• Tactical• Product features• Promotion• Merchandising• Pricing• Sales channels• Service

SNo Brand Name Manufacturers Type Unit

1 Acneclin Themis Pharmaceuticals Limited Oint 10 gm

2 Acneris Psyco Remedies. Oint 10 gm

3 Acneriv East African (I) Remedies Pvt Ltd Oint 15 gm

4 acnesol (20 gm) Systopic Laboratories (P) Ltd. Oint 20 gm

5 Acnethro C Salve Pharmaceuticals Pvt. Ltd. Oint 15 gm

6 Biolinx Bio Sciences Pharmakon Capsule 150mg

7 Braclin-300 Plenus Pharmaceuticals Pvt Ltd Injection 300mg

8 Braclin-600 Plenus Pharmaceuticals Pvt Ltd Injection 600mg

9 Carebet -Clin Sure Care Pharma (P) Ltd. Oint 10 gm

10 Clid Bennet Pharmaceuticals Capsule 150mg

11 Clid (2 ml) Bennet Pharmaceuticals Capsule 150mg

12 Clid (20 gm) Bennet Pharmaceuticals Oint 20 gm

13 Clid (300 mg) Bennet Pharmaceuticals Capsule 150mg

14 Clid Gel Bennet Pharmaceuticals Oint 20 gm

15 Clim Canbro Healthcare Oint 20 gm

16 Climycin Neon Laboratories Ltd Capsule 150mg

17 Clin -Gold Indkus Drugs Pharma (P) Ltd Oint 10 gm

18 Clincin Indi Pharma Pvt. Ltd. Capsule 150mg

Some International Clindamycin Formulation

Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price

CINAMYCIN IBN SINA Pharmaceutical Industry Ltd. Clindamycin hydrochloride 150mg & 300 Capsule 30's each: 240.00 & 450.00 MRP

CLIMYCIN 300 Square Pharmaceuticals Ltd. Clindamycin 300mg Capsule 30's: 451.50 MRP

Clindacin 150 Incepta Pharmaceuticals Limited Clindamycin Hydrochloride BP equivalent to Clindamycin 150 mg Capsule 10x3's:MRP 240 Tk

Clindacin 300 Incepta Pharmaceuticals Limited Clindamycin Hydrochloride BP equivalent to Clindamycin 300 mg Capsule 10x3's:MRP 450 Tk

Clindacin 600 Injection Incepta Pharmaceuticals Limited Clindamycin Phosphate 300mg/4ml Injection 1x5's:MRP 350 Tk

Clindacin Cream Incepta Pharmaceuticals Limited Clindamycin 2% Vaginal Cream Cream 20gm x 1:MRP 70 Tk

Clindacin Lotion Incepta Pharmaceuticals Limited Clindamycin 1% Lotion Lotion 25ml:MRP 125 Tk

Clindacin plus Incepta Pharmaceuticals Limited Clindamycin Phosphate 1.2% +Tretinoin 0.025% Gel Gel 15gm x 1:MRP 150 Tk

Clindacin Powder Incepta Pharmaceuticals Limited Clindamycin 75 mg/5 ml Powder For Suspension

Powder for oral solution 1x1's:MRP 280 Tk

CLINDAX Opsonin Pharma Limited Clindamycin hydrochloride 75mg/5ml Oral Solution 100ml: 250.00 MRP

CLINDAX Capsule Opsonin Pharma Limited Clindamycin hydrochloride 150mg & 300 Capsule 30's each: 240.00 & 450.00 MRP

CLINDAX Cream Opsonin Pharma Limited Clindamycin phosphate BP 20mg/gm Cream 20gm: 70.00 MRP

CLINDAX Lotion Opsonin Pharma Limited Clindamycin Phosphate USP 10mg/ml (1% w/v) Lotion 25ml: 125.00 MRP

CLINEX Aristopharma Ltd. Clindamycin Phosphate USP 10mg/ml (1% w/v) Lotion 25ml: 125.00 MRP

CLINEX Capsule Aristopharma Ltd. Clindamycin hydrochloride 300mg Capsule 30's: 450.00 MRP

DACLIN Capsule ACI Ltd. Clindamycin hydrochloride 150mg & 300 Capsule 30's each: 240.00 & 450.00 MRP

DALACIN C Janata Traders Clindamycin hydrochloride 300mg Capsule 16's: 848.16 MRP

LINDAMAX Eskayef Bangladesh Ltd Clindamycin Hydrochloride BP equivalent to Clindamycin 150mg & 300mg Capsule 30's each, MRP: 240.00 & 450.00

XINDAL Orion Pharma Ltd. Clindamycin hydrochloride 300mg Capsule 30's: 450.00 MRP

Some Bangladeshi Clindamycin Formulation

1. In IMS we have positive share & growth in negative market trend.

2. Internal brand growth is positive.3. Strong brand name .

4. Excellent coverage in Specialty and GP level.

5. Reputation of Company.6. Attractive getup of Tablet.

1. Lack of coverage.2. Capsule form is preferable

than tablet.3. Lack of promo materials.

4. We don’t have procedure of formulation.

1. Opportunity to launch Clindamycin tablet For the First

time. 2. Promote Clindamycin tablet with

broad activity.3. Bangladeshi people may prefer

tablet form.

01.Chloramphenicol, Tetracycline,

AZITHROMYCIN may threat for Clindamycin.

02. Negative growth of Clindamycin molecule.

Clindamycin

Tablet SWOT

Analysis

Weakness

Opportunity

Strengths

Threat

Internal factors strengths weakness factors opportunities threatsmanagement favourable economic unfavourable yesmarketing favourable competition favourable nomanufacturing unfavouable yes consumer favouanleR&D Unfavourable yes technology unfavouablefinance unfavouable Legal/regulatory unfavourable

offerings unfavourable no industry unfavouable no

Establishment Objective

Have To create new customer and keep existing customer. To build brand image Clindamycin Tablet day will be performed.

To increase sales of Clindamycin Tablet, Chemist/PC conference will be performed.

• coated core particles of clindamycin are overcoated with a binder-dispersing agent, such as povidone; streptococci, pneumococci, and staphylococci infections

Problems : production of

clindamycin tabletGoal:production of

clindamycin oral tabletHypothesis:produce

new form

Introduction

The present invention is directed to an extended release multiparticulate formulation of a therapeutic agent, wherein coated core multiparticulate particles of the therapeutic agent are overcoated with a binder-dispersing agent, such as povidone or cross-povidone. The invention is also directed to compressed tablets of the extended release multiparticulate formulation of the invention, and to a method of oral administration of compressed tablets of clindamycin to a subject to treat or prevent a gram-positive bacterial infection therein. The binder-dispersing agent in the formulations of the present invention ensure that compressed tablets formed therefrom will remain intact through oral administration, and dissolve shortly thereafter, enabling the multiparticulates to release the therapeutic agent contained therein over an extended period of timei

MethodUsing binder like

povidon.erdgt,pvc,other flavouring

agent,diluent,adhesive for making clindamycin oral

tablet

ResultSome therapeutic agents, such as

clindamycin, are particularly difficult to produce in the form of compressed tablets

of multiparticulates due to the fact that they tend to behave like a monolithic tablet when multiparticulates thereof are directly

compressed into tablets, failing to disintegrate within less than 30 minutes, as

is preferred for multiparticulate tablets. Furthermore, the recommended dosage of

some agents, such as clindamycin, is relatively large for an average adult human. In an unpublished study, oral compressed tablets produced by directly compressing

multiparticulate clindamycin were found to demonstrate a sustained release rate.

However, the tablets behaved like monolithic tablets, failing to disintegrate in

a 24 hour dissolution test. As part of the same study, it was found that disintegration

time could be reduced by the addition of extra-multiparticulate material to the

formulation; but, a significant increase in tablet size was needed in order to

incorporate the extra-multiparticulate material. The resulting tablet size was so

large that oral administration to an average adult human would be impractical

Reference:https://www.google.com/patents/US20040228915

Conclusion :It has some difficulties for clindamycin

tablet formulation

• The safety of use in pregnancy has not been established.

• Clindamycin has been reported to appear in breast milk.

• If therapy is prolonged, liver and renal function tests may be monitored periodically.

• People Prefer Capsule form than Tablet form. • People prefer Cephalosporin And Tetracycline

than Clindamycin• It needs 2-3 years for clindamycin Tablet

formulation which is not favourable• The resulting tablet size was so large that oral

administration to an average adult human would be impractical

• Tablet manufacturing cost may be higher than available capsule form

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Conclusion

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Reference

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Thanking you

Have a good day………………. 16