Solid Dosage Forms Natural Medicinal Product

Solid Dosage Forms Natural Medicinal Product

PHMT2292 Nutraceuticals Product Development Kausar Ahmad [email protected] PHM2292 Nutraceuticals - Product Development 1 CONTENTS

Halal Products Materials & active ingredients Dosage forms Selection of excipients Processing Issues & Regulatory PHM2292 Nutraceuticals - Product Development

2 Halal Products PHM2292 Nutraceuticals - Product Development 3 MS2424:2012 6 HALAL CERTIFICATES - HALAL CERTIFICATION BODIES

Jabatan Kemajuan Islam Malaysia, JAKIM, is the body entrusted with the issuance of the halal certificate. JAKIM can get the involvement of the religious bodies in the respective state to handle the request for halal certification. In the state of Pahang, representatives from Jabatan Agama Islam Pahang (JAIP) may audit product in the Notification category such as hand sanitisers. Due to worldwide distribution of halal products, JAKIM has

endorsed selected foreign halal approving bodies that provide halal certification e.g. Australian Federation of Islamic Councils Inc. without doubt. MS2424:2012 7 HALAL CERTIFICATION MARK - HALAL LOGO Reference/Certificate number for the halal product Guideline used for the manufacturing process

The approved halal logo issued by JAKIM with the manufacturing standard used and the certificate number to be positioned beneath the logo PHM2292 Nutraceuticals - Product Development 6 PHM2292 Nutraceuticals - Product Development 7

SOURCE OF RAW MATERIALS Traditional use PHM2292 Nutraceuticals - Product Development 8 PLANT MATERIALS PHM2292 Nutraceuticals - Product Development 9

NATURE OF ACTIVE INGREDIENTS PHM2292 Nutraceuticals - Product Development 10 COMPOUND - ARBORINE PHM2292 Nutraceuticals - Product Development 11

Which Dosage Form? PHM2292 Nutraceuticals - Product Development 12 PREFORMULATION TESTS Organoleptic properties Purity of API and excipients Analytical method Solubility Hygroscopicity

Ionization/dissociation constant (pKa) Partition coefficient (Log P) Dissolution behaviour Crystallinity and polymorphism Particle size, shape and surface area Bulk density Powder flow property Pearmeability Stability Drug-excipient compatibility PHM2292 Nutraceuticals - Product Development

13 EXCIPIENTS PHM2292 Nutraceuticals - Product Development 14 DILUENT OR FILLER PHM2292 Nutraceuticals - Product Development

15 LACTOSE: FILLER PHM2292 Nutraceuticals - Product Development 16 BINDER PHM2292 Nutraceuticals - Product Development

17 DISINTEGRANT PHM2292 Nutraceuticals - Product Development 18 GLIDANT, LUBRICANT AND ANTI-ADHERENT PHM2292 Nutraceuticals - Product Development

19 TABLET FORMULATION Material Dried leaves/Crude extract Lactose PVP Starch Talc Aerosil TOTAL Composition (% w/w) 10

40 10 20 10 10 100 PHM2292 Nutraceuticals - Product Development 20 CAPSULATION Material

Composition (% w/w) Dried leaves/Crude extract 10 Lactose 60 PVP 20

Sodium starch glycolate 10 TOTAL 100 PHM2292 Nutraceuticals - Product Development 21

TABLETTING PHM2292 Nutraceuticals - Product Development 22 TYPES OF CAPSULES PHM2292 Nutraceuticals - Product Development 23

CAPSULATION PHM2292 Nutraceuticals - Product Development 24 ISSUES Is there a quality issue? Adulteration? Is there an efficacy issue? PHM2292 Nutraceuticals - Product Development

25 GUIDELINES ON SPECIFICATIONS NPR DEPARTMENT, MALAYSIA 1. Heavy metal analyses: a. Mercury: max. 0.5 ppm b. Arsenic: max. 5.0 ppm c. Lead: max. 10 ppm 2. Microbial contamination results 3. Disintegration test (for tablets and capsules only) PHM2292 Nutraceuticals - Product Development

26 ISSUE 1: HEAVY METAL CONTAMINATION Not uncommon for traditional products (Chan, 2003; Ting et al., 2013). Plants and herbs may have carryover of heavy metals from the soil. Heavy metal content due to contamination of fishes in many seas due to mercury is a concern. So, is fish oil safe? Chan, K. (2003). Some aspects of toxic contaminants in herbal

medicines.Chemosphere 52(9), 1361-71. Ting, A, Chow, Y & Tan, W. (2013).Microbial and heavy metal contamination in commonly consumed traditional Chinese herbal medicines. J Tradit Chin Med. 33(1),119-24. Posadzki, P., Watson, L. & Ernst, E. (2013). Contamination and adulteration of herbal medicinal products. Eur J Clin Pharmacol. 69 (3), 295-307. doi: 10.1007/s00228-012-1353-z. Epub 2012 Jul 29. PHM2292 Nutraceuticals - Product Development 27 SOME EXAMPLES OF NMP FROM OKUNLOLA ET AL. (2007) Dosage form

Tablet Contents Therapeutic claim Gingko biloba extract, Ganoderma lucidum, Brain fatigue, Schisandra chinensis improvement of thought process. Capsule Strophanthus sarmentosus 75%, Pyrenancantha 25% Hibiscus sabdariffa, Sorghum bicolor,

Gongronema latifolium Suspension Solution Chronic fever, Cough Immune booster, Energizer, Blood normalizer Enantia chloranthia, Mormodica charanthia, Antimalarial Citrus aurontifolia, Morinda Cocos nucifera, Occimum gratissimum,lucida, Azaridachta indica,

Reference: Adenike Okunlola, Babatunde A. Adewoyin and Oluwatoyin A. Odeku. Evaluation of Pharmaceutical and Microbial Qualities of Some Herbal Medicinal Products in South Western Nigeria. Tropical Journal of Pharmaceutical Research, March 2007; 6 (1): 661-670. Retrieved March 13, 2015 from PHM2292 Nutraceuticals - Product Development 28 FINDINGS BY OKUNLOLA ET AL. (2007)

Twelve (57.1%) of the products had their manufacturing and expiry dates stated, Nine (42.9%) products have been registered by NAFDAC Ten (47.6%) did not have their content stated but had their therapeutic claims indicated on the container. The tablet formulation (Product A) showed acceptable crushing strength and friability but failed the test for disintegration time. The angle of repose of the powder dosage forms were considerably high showing that the powders were highly cohesive and not free flowing.

The microbial load of the products varied considerably. Ten (47.6%) of the samples were contaminated by E. coli, seven (33%) were contaminated by Salmonella, fifteen (71.4%) were contaminated by Staphylococcus aureus and twelve (57.1%) were contaminated by fungi. PHM2292 Nutraceuticals - Product Development

29 FINDINGS BY GUPTA ET AL. (2012) 20 herbal products as tablet, powder and capsule were evaluated Isolation and identification of microbial contamination showed that all samples were contaminated with Salmonella sp. Reference: DK Gupta, RD Sharma, R Gupta, S Tyagi, KK Sharma (2012), Evaluation of Some Herbal Solid Dosage Forms for Microbial Contamination, Int J PharmPharm Sci, Vol 4, Suppl 4, 261-263 PHM2292 Nutraceuticals - Product

Development 30 ADULTERATION Adulteration refers to the accidental or intentional addition or substitution or dilution of a material with an ingredient (not disclosed, lower-cost) PHM2292 Nutraceuticals - Product Development 31

ADULTERATION OF HERBAL PRODUCTS Posadzki, P., Watson, L. & Ernst, E. (2013). PURPOSE: To summarise and critically evaluate the evidence from systematic reviews. METHODS: Five electronic databases were searched to identify all relevant systematic reviews. RESULTS: Twenty-six systematic reviews. The most commonly HMPs were adulterated or contaminated with dust, pollens, insects, rodents, parasites, microbes, fungi, mould, toxins, pesticides, toxic heavy metals and/or prescription drugs. The most severe adverse effects caused by these adulterations were agranulocytosis, meningitis, multi-organ failure, perinatal stroke, arsenic, lead or mercury poisoning, malignancies or carcinomas, hepatic encephalopathy, hepatorenal syndrome, nephrotoxicity, rhabdomyolysis, metabolic acidosis, renal or liver failure, cerebral

edema, coma, intracerebral haemorrhage, and death. Adulteration and contamination of HMPs were most commonly noted for traditional Indian and Chinese remedies, respectively. CONCLUSIONS: More stringent quality control andPHM2292 its enforcement seem to be necessary to avoid health Nutraceuticals - Product 32 risks. Development ISSUE 2: PHARMACOKINETIC AND BIOAVAILABILITY Evidence-based verification of efficacy

Analytical data for bioavailability elucidation of metabolic pathways (yielding potentially new active compounds), and the assessment of elimination routes and their kinetics. Interaction with synthetically-derived drug Reference: Bhattaram VA, Graefe U, Kohlert C, Veit M, Derendorf H. Pharmacokinetics and bioavailability of herbal medicinal products. Phytomedicine. 2002;9 Suppl 3:1-33. Review. PubMed PMID: 12222652. PHM2292 Nutraceuticals - Product Development 33

CONCLUSION * Action plan http:// 9ce756077e36d05afbf3fa106057d344 PHM2292 Nutraceuticals - Product Development 34 Exercise Identify the nutritional benefits of the following items and discuss with your BFF on

the best dosage form: Ketum Petai Peria PHM2292 Nutraceuticals - Product Development 35

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